Mako Surgical Corp. 2555 Davie Roadgmcboard.vermont.gov/sites/gmcb/files/files/certificate...Mako...

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Transcript of Mako Surgical Corp. 2555 Davie Roadgmcboard.vermont.gov/sites/gmcb/files/files/certificate...Mako...

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Mako Surgical Corp. 2555 Davie Road Fort Lauderdale, FL 33317 t: 954 927 2044 f: 954 927 0446 www.stryker.com

PREPARED FOR: Brattleboro Memorial Hospital OFFER EXPIRATION DATE: March 31, 2017 Date Created: 2/23/2017

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Mako Surgical Corp. 2555 Davie Road Fort Lauderdale, FL 33317 t: 954 927 2044 f: 954 927 0446 www.stryker.com

EQUIPMENT

MAKO™ ROBOTIC ARM SYSTEM AND APPLICATION(S)

Total Knee Application will be installed following commercial release and

upon availability for shipment to customer’s facility.

QTY. PART # EQUIPMENT List Price Discounted Price

1 210000 Stryker Robotic Arm System (MakoTM/RIO®)

Includes:

1 209999 RIO® Surgical Arm

1 207110 RIO® Guidance Module

1 209927 RIO® Camera Stand Assembly

1 211394 RIO® Accessory Kit 3.0

1 211845 MakoTM Partial Knee Application

Includes:

1 100020 RESTORIS® Partial Knee Software License

2 111758 MAKOplasty® Partial Knee End Effector

2 151030 MAKOplasty® Partial Knee Array Kit

1 200681 MAKOplasty® Partial Knee CT Scan Kit

2 110570 IMP DeMayo Leg Positioner - 25" Kit

2 EMAX2PLUS Anspach EMAX 2 Plus Motor

2 EMAX2-TRAY Anspach EMAX 2 Sterilization Case/Tray

2 ACB Anspach EMAX 2 Cleaning Brush

4 LONG-HD Anspach EMAX 2 Long Attachment

1 203997 Surgeon & Surgical Staff Training, Knee

1 212025 Mako PKA 2.5/RIO 3.0 User Manuals Master CD

2 200004 Mako PKA CT Scanning Protocol

1 201845 Mako PKA Instrument Cleaning and Sterilization Guide

TOTAL 1,015,000$ 650,000$

MIN QTY. PART # EQUIPMENT List Price Discounted Price

1 212183 Mako Total Knee Application

Includes:

1 212184 Mako TM Total Knee Software License

2 151050 Mako MICS Handpiece & Knee Attachment Kit

2 151100 Mako Knee Array/ Balancing Tray Kit

2 151150 Leg Positioner Tray Kit

1 212199 Mako TKA User Manuals Master CD

1 210551 Mako TKA Instrument Cleaning and Sterilization Guide

2 200004 Mako Knee CT Scanning Protocol

1 212249 Surgeon & Surgical Staff Training, Total Knee

Total 400,000$ 300,000$

MakoTotal Knee Application

MakoTM

System with Partial Knee Application

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Mako Surgical Corp. 2555 Davie Road Fort Lauderdale, FL 33317 t: 954 927 2044 f: 954 927 0446 www.stryker.com

WARRANTY & SERVICE AGREEMENT Purchase includes one (1) year standard warranty on the originally installed Equipment. Thereafter, Customer may enter into a Service Agreement for four (4) years beginning one year after the installation of the Equipment. Service coverage includes all hardware, firmware, installation, parts, labor and preventive

maintenance (excluding damage due to vandalism). On-site response within twenty four (24) hours, during local business hours. Local business

hours are Monday through Friday, excluding holidays from 8:00 a.m. to 5:00 p.m. Loaner Equipment may be shipped for continuing downtime of forty eight (48) hours or

more. Replacement parts as required on an exchange basis, excluding consumable items. Travel and related expenses to and from service site.

SERVICE CONTRACT ANNUAL COST $95,000

OTHER KEY TERMS Robotic-Arm Destination Agreement In recognition of their shared interest in educating prospective patients and health care

professionals concerning the benefits of robotic-arm assisted surgery as a treatment option for

certain conditions, Mako Surgical Corp. (“Stryker Mako”) encourages Customer to partner with

Stryker Mako in the development and promotion of Customer’s facility as a Robotic-Arm Destination

offering a state-of-the-art robotic-arm assisted surgery program. Customer and Stryker Mako

would collaborate to support efforts related to marketing, public relations and patient education. In addition, Stryker Mako will assign a Marketing Specialist to collaborate with employee(s) of

Customer and its surgeons to implement a number of best practices established in robotic-arm

assisted surgery sites across the country.

Additional Conditions Stryker Mako will extend all of the aforementioned additional conditions provided that Customer signs a binding written agreement and accepts delivery and installation of the Equipment on or before the expiration date of this Executive Summary.

This Executive Summary is for discussion purposes only and is NOT an offer to sell from Stryker Mako and shall not be binding for such purposes. Any order shall be offered and accepted only when made pursuant to a binding written agreement between Stryker Mako and Customer.

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DRAFT INTERNAL PURPOSES ONLY

Mako Robotic-Arm Assisted System: A Clinical and Economic Analysis for Health Plans and Providers.

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DRAFT INTERNAL PURPOSES ONLY

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About this document

This document, prepared by Baker Tilly, LLP at the request of Stryker, presents health plans and

providers with clinical and economic information supporting the Mako Robotic-Arm Assisted System

(‘Mako’) as a safe and effective surgical tool that surgeons can use to help achieve greater accuracy

of component placement and enhance patient satisfaction during hip and knee arthroplasty

procedures. Moreover, this document supports Mako’s use within current standard-of-care

treatment protocols and reimbursement parameters.

The studies relied on in this document are of varying design, ranging from large randomized

controlled trials (RCTs) to single-surgeon studies and cadaver studies. As a result of variations in

study design, the robustness of the data arising from different studies may vary. The document

includes descriptions of studies relied upon and published sources are cited throughout. We

encourage you to consult the cited publications.

Executive Reimbursement Statement:

Many payers consider the robotic surgical system a tool or technique that is “integral to the primary

procedure.” This policy is employed by payers in the U.S. such as UnitedHealthcare and Humana.a

Moreover, some payers state that “[s]uch matters are left to the discretion of the surgeon.”a

Recommended approach, or reimbursement statement, if necessary:

“Robotic-Arm Assisted Systems are integral to the primary surgical procedures (e.g., hip and knee arthroplasties), and as such, these systems are available for surgeons to use at their discretion within existing reimbursement parameters.”

a Policies in place as of April 18, 2016.

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Purpose:

The purpose of this report is to provide clinical and economic evidence of the Mako Robotic-Arm

Assisted System (‘Mako’) to support coverage and adoption of this technology. Mako is an assistive

tool that is ancillary to the primary procedure and is designed to enhance the surgical outcome.

Mako has demonstrated value to surgeons, patients, hospitals, and payers through clinical and

operational benefits. For example, studies have shown surgeons using Mako for assistance in

unicompartmental knee arthroplasty (UKA) have demonstrated the following value when compared

to non-robotic UKA and/or total knee arthroplasty (TKA) that do not include the Mako Robotic-Arm

Assisted System:

• More accurate implant placement1-3

• Lower early post-operative pain4

• Reduced average length of stay for the index procedure5

• Reduced revision rates at 24 months6-8

Legend:

ALOS: Average Length of Stay

PMPM: Per Member Per Month

TKA: Total Knee Arthroplasty

THA: Total Hip Arthroplasty

UKA: Unicompartmental Knee Arthroplasty

CJR: Comprehensive Care for Joint Replacement

IPSAF: Inpatient Standard Analytical File

OPSAF: CMS Medicare Outpatient Standard Analytical File

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A retrospective analysisb of the OptumInsight commercial claims database (2013 to 2015)

documented the following favorable trends for robotic-assistance associated with UKAs:

Category Non-Robotic

UKA Robotic-UKA Difference

Percent Reduction

p-value

Index Cases (patients) 1,312 284

Revision Cases (patients) 46 1 -45

24 Month Revision % 3.5% 0.4% -3.1% 88% 0.004

In addition, for this same population of commercial patients, all-cause readmissions and their

associated payer costs were lower for the robotic-assistance group in key episode-of-care time

intervals as follows:

Episode Length 30 days 90 days

Metric Readmission

rate (%) Allowed per

readmission ($) Readmission

rate (%) Allowed per

readmission ($)

Non-robotic 1.10% 15,881 4.20% 25,286

Robotic assistance 0.70% 15,009 3.50% 10,328

% Difference 36.36% 872 16.67% 14,958 Overall readmission cost reduction 40% 66%

While these readmission rate and cost findings have substantial quality and patient satisfaction

implications, they also suggest that payers, employers, and hospitals participating in bundled

payments (i.e., Comprehensive Care for Joint Replacement) may reduce costs for hip and knee

arthroplasty surgery when physicians use robotic assistance.

The following is a summary of key value points for Mako which are discussed and sourced in greater

detail in the ensuing narrative:

• Since Mako’s market release, over 70,000 joint arthroplasty proceduresc have been performed

using the Mako system. In 2016, Mako is available in less than 5% of U.S. hospitals and is

estimated to be utilized for approximately 1% of all applicable joint arthroplasty procedures in the

U.S.d

b Analysis conducted by Baker Tilly using a database compiled by OptumInsight, Inc. (Eden Prairie, MN) comprising

claims generated by a national commercial health plan consisting of approximately 25 million members. Index cases incurred Jan. 2013 – Dec. 2013, revision cases incurred within 24 months of index procedure. This commercial data has not been blended with Medicare or Medicare Advantage data. c www.Stryker.com. Accessed May 12, 2016.

d Analysis conducted by Baker Tilly using Mako volume and installations provided by Stryker Orthopedics.

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• Over 30 published peer-reviewed studies have reported favorable outcomes with the use of

robotic-arm assistance.

• A Level 1 randomized controlled trial has demonstrated UKAs with robotic-arm assistance had

more accurate implant placement 4,9

and less early post-operative pain than non-robotic UKAs.4,9

• For total hip arthroplasty (THA), the use of the Mako Total Hip application has demonstrated

more accurate component positioning,10-12

which may lead to greater range-of-motion, reduced

soft-tissue damage, decreased bone-to-bone impingement, and enhanced stability.11

• Mako can be used in all surgical facility types including ambulatory surgical centers, community

hospitals, and large academic centers. This means that payers can potentially benefit from

patients seeking care at lower cost, but high quality, ambulatory surgical centers and community

hospitals.

• Mako facilitates enhanced precision4,9

and enables surgeons to perform technically challenging

UKA procedures. Several studies have shown that meaningful subsets of patients treated with

TKA may have been candidates for UKAs.13-15

Moreover, a 2011 study that reviewed surgeries

performed by seven (7) clinicians at the same tertiary site found 21% of cases treated with a

TKA could have been treated with a UKA.13

Note: UKA with robotic-arm assistance has shown a significantly lower adverse event rate

(less than 1%) than that of non-robotic UKAs (3.5%) in a retrospective analysis of

commercial claims (OptumInsight commercial claims database 2013 to 2015). UKA with

robotic-arm assistance also drives lower index and revision procedure costs when

compared to non-robotic UKAs and/or TKAs (OptumInsight commercial claims database

2013 to 2015).

• To the extent UKA candidates are currently undergoing TKAs,13 -15

and the use of robotic-arm

assistance can allow surgeons to perform UKAs when appropriate in a lower cost outpatient

setting, the use of Mako may lead to savings for payers. In an analysis of the OptumInsight

commercial claim database (2013 to 2015) with the following conservative assumptions, Mako

has the potential to deliver a potential savings of $0.02 to $0.05 Per Member Per Month

(PMPM).

o Five to twelve percent (5-12%) of procedures are switched from TKA ($30,982) to

robotic-arm assisted UKA ($30,398),

o Ten percent (10%) migration from an inpatient setting to hospital outpatient,

o Reduced readmissions per the study described herein,

o Industry-standard utilization and cost growth projection to 2020.

Note: If, as seen in the 2011 study referenced above,13

21% of UKA candidates were treated

with a UKA where robotic-arm assistance was used, the savings can increase to $0.09

PMPM. Furthermore, if a 20% migration from inpatient to hospital outpatient is realized, savings

can increase to $0.30 PMPM by 2020.

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Introduction:

The Mako Robotic-Arm Assisted System

The Mako Robotic-Arm Assisted System allows surgeons to treat painful knee and hip conditions

with reproducible precision and more accurate implant alignment.2,3

It allows surgeons to optimize

current and proven standard surgical approaches for joint arthroplasty. The robotic technology

facilitates more accurate component placement1-3,16,19

and helps to eliminate unnecessary variation

in the surgical process across surgeons.4

The Mako System’s ability to enable surgical and implant

placement accuracy begins with patient-specific pre-operative planning. Pre-operative planning is an

Enhanced planning

Patient-specific pre-operative plan enables

accurate implant sizing and positioning.1-3,16,17

Functional positioning

Surgeon-controlled intra-operative adjustments can be made

to optimize implant placements.45

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essential prerequisite for the success of many orthopedic procedures. Emerging evidence to date

suggests that pre-operative planning may be an effective means of favorably influencing the

outcomes of orthopedic procedures.20 Mako’s pre-operative, computer-assisted 3D planning allows

surgeons to evaluate the bone structure, alignment, and joint space as well as the surrounding

tissue, so that the surgeon can plan the patient-specific orientation for the implant, select the

appropriate size implant, balance the soft-tissue and ensure proper alignment.21

In the operating room, the robotic-arm system provides real-time data to the surgeon, allowing

continuous assessment of ligament tension and range-of-motion during implant placement and

articulation. Mako technology allows the surgeon to make intra-operative adjustments, as needed,

to optimize joint implant placement.21

In addition, the real-time data collected through Mako

technology enables the surgeon to avoid transection of vital structures, which has shown to reduce

blood loss. The decrease in blood loss associated with Mako may be attributed to a number of

factors including a smaller incision, decreased soft-tissue trauma, and conservative reaming for hip

arthroplasty.18

These benefits potentially eliminate the need for routine post-operative hemoglobin

monitoring and post-procedure blood transfusions, all factors which could lengthen the patient’s

hospitalization.22

Importantly, by using real-time data, surgeons are able to refine the surgical plan

intra-operatively to achieve soft-tissue balance, resulting in patients who are more likely to forget

their artificial joint in daily life.23

The Mako Robotic-Arm Assisted System was released in 2006 for use during partial knee

arthroplasty surgery and in 2010 for total hip arthroplasty surgery (Mako plans to have a market

release in 2017 for total knee arthroplasty). To date, approximately 70,000 patients or 1% of those

receiving a partial knee or hip arthroplasty procedure in the United States have received the benefit

of Mako robotic assistance. Over 30 studies summarizing the results of procedures performed with

the Mako System, including several randomized trials, have been published in peer-reviewed

journals. Results from many of these studies have reported that Mako is associated with enhanced

clinical outcomes.4,18

Key studies are highlighted in this document. A full bibliography is available

upon request.

Burden of Disease: The Cost of Osteoarthritis is Unsustainable without Treatment

Changes

Osteoarthritis, the most common form of arthritis, affects more people than any other joint disease

and is the most widespread cause of walking-related disability in people over the age of 65 years.24-

26 Osteoarthritis has been estimated to affect nearly 27 million adults in the United States.

27 Among

adults 60 years and older in the United States, an estimated 37.4% have osteoarthritis.28

Due to the

aging population and increasing trends in joint injury, the number of affected adults with

osteoarthritis is expected to increase by about 50% over the next 20 years (with the caveat that past

projections have underestimated future burden).29

The morbidity associated with osteoarthritis is considerable:

• 80% of individuals report limitations of movement,

• 25% of those have difficulty performing major activities of daily living.30

While osteoarthritis-related symptoms such as physical pain affect patients’ quality of life, the burden

of osteoarthritis extends far beyond that, to encompass the social and personal aspects of everyday

functionality.31

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The economic burden of osteoarthritis in the United States is estimated to be more than $60 billion

per year, with job-related costs reaching as much as $13 billion per year.24

As the fourth-most

common cause for hospitalization, a diagnosis of osteoarthritis is attributed to approximately 12

million ambulatory care visits and 85,000 emergency room visits per year.32

Osteoarthritis is the leading indication for joint arthroplasty surgery, which is expected to grow

exponentially. By 2030, demand for knee arthroplasty is projected to grow by 673% or to 9.6

procedures per 1,000, while the demand for primary total hip arthroplasty is estimated to grow by

174% or to 1.6 procedures per 1,000. As the number of primary procedures increases, so will the

number of joint revision procedures.33

This trend demands that providers and payers collaborate to

manage this segment of the population.33

Joint Arthroplasty - Treatment Complications and Adverse Events

Joint replacement or arthroplasty is most often performed for painful arthritis that limits activities of

daily living and the pain is not relieved by medications or other conservative therapies. Joint

arthroplasty has been performed with favorable outcomes over the past several decades and is a

proven medical advancement in the field of orthopedic surgery.34

That said, a revision procedure

may be necessary due to an ineffective primary joint procedure.35

This can be due to infection

involving the joint, bone loss in the structures supporting the prosthesis, fracture, loosening of the

implant, among others.36

The risk of an ineffective primary procedure may also be affected by

patient factors such as age, weight, activity level, rehabilitation compliance, and the presence of co-

morbidities, as well as by the surgical technique. Complications associated with the surgical

procedure can include incorrect ligament balancing, poor cement technique, and malrotation of

implant parts. Major perioperative adverse events are reported in under 7.5% of patients and most

often become manifest within four days following the implant procedure.22,37

Clinical Studies

Partial Knee Arthroplasty (PKA) with Robotic-Arm Assistance

For patients who are appropriate candidates for a partial knee arthroplasty (PKA)/unicompartmental

knee arthroplasty (UKA), Mako technology can help to preserve healthy ligaments to maintain

stability and control. Partial knee arthroplasty for patients with osteoarthritis isolated to only 1 or 2

compartments makes it possible for the surgeon to “save” (i.e., avoid cutting) the anterior cruciate

ligament (ACL) and posterior cruciate ligament (PCL), as well as healthy bone and tissue.

Minimizing tissue disruption may reduce recovery time, thereby reducing the risk of complications,

hospital days, and associated costs.38,39

Traditional, non-robotic partial knee procedures, however,

are technically challenging and difficult to perform with accuracy, which is why surgeons tend to

perform total knee procedures on potential UKA candidates.2

One major limitation of a non-robotic UKA procedure is the high failure rate associated with

inaccurate placement of the implant due, in part, to a restricted visual field. Successful UKA requires

proper placement of components in multiple planes, where even the slightest abnormality in implant

depth can cause complications.1 As discussed below, Mako Robotic-Arm assisted procedures may

help to overcome the technical challenges associated with non-robotic UKA procedures.

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Variability

• Robotic-arm assisted UKA procedures have demonstrated 2 to 3 times less variability when

compared to non-robotic procedures, and more reproducible results, allowing for enhanced

accuracy with respect to magnitude of tibial slope, degree of error in the coronal plane, and femoral

component placement. 1-3,21,40,41

In a retrospective comparison of patients who underwent Mako

Robotic-Arm assisted UKA (n=31 patients) with patients who underwent non-robotic UKA (n=27

procedures) by the same surgeon, tibial component alignment was found to be more accurate

and less variable for Mako-guided surgeries compared to those with non-robotic

instrumentation.3

Implant Placement Accuracy

• In a Level 1 randomized controlled trial (RCT), UKA with robotic-arm assistance showed

significantly improved implant placement accuracy compared with non-robotic UKA implantation.

In the RCT (n=139 patients) comparing the two techniques for UKA, surgeons using robotic-arm

assistance achieved the precise preoperative plan more frequently than when doing non-robotic

UKA surgery.4

Revisions

• Low revision rates are evidence of enhanced outcomes for robotic-arm assisted UKA patients.

In a large multicenter study (n=797 patients; 909 knees) of 6 surgeons, robotic-arm assisted

UKA procedures had a cumulative revision rate of 1.2% and high patient satisfaction at an

average of 29.6 months follow-up (range: 22 to 52 months). This revision rate is substantially

lower than reported rates for non-robotic UKA of 4.5 and 4.8% at a 2-year follow-up (Swedish

and Australian national registries, respectively).6-8,42

Error in Degrees Error in Degrees

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Post-Operative Pain and Follow-Up Provider Visits

• Lower post-operative pain and a reduction in office visits and hospitalizations have been

experienced by patients. In a prospective, randomized controlled trial (n=139 patients), patients

who had UKA with robotic-arm assistance experienced significantly less pain at 7 days (p=0.041)

post-operation and greater functioning at 3 months post-operation, as measured by American

Knee Society Scores >160 (excellent). Furthermore, the number of office visits to general

practitioners and hospitalizations in the 3 months following surgery were also lower for robotic-

arm assisted UKA patients.4

o Office visits: 30% (robotic assistance) vs. 45% (non-robotic)

o Hospitalizations within 3 months of surgery: 3% (robotic assistance) vs. 8% (non-robotic) and;

o 54 bed-days saved per 100 patients.4

Patient Satisfaction

• Patient satisfaction scores are also evidence of enhanced outcomes for patients who underwent

a UKA with robotic-arm assistance. At the 2-year follow-up, nearly all (92%) patients indicated

that they were either very satisfied or satisfied with their robotic-arm assisted UKA procedure.6

• Additionally, patients who undergo UKA are more likely to forget their artificial joint in daily life

and consequently may be more satisfied. A study of 139 patients found that at both one and two

year follow-up, patients who received a UKA with robotic-arm assistance had a higher Forgotten

Joint Score (FJS), than patients who received a TKA. (FJS 1 year 73.9 +/- 22.8 vs. 59.3 +/-

29.5; FJS 2 year 74.3 +/- 24.8 vs. 59.8 +/- 31.5 (p = 0.002)).23

Total Hip Arthroplasty (THA) with Robotic-Arm Assistance

Despite the substantial improvements in THA, due to an increase in THA procedures, complications

and early mechanical failures have increased in occurrence.34

Total hip arthroplasty revisions are

often linked to malpositioned acetabular components, which may result in:

• dislocation,

• impingement,

• component wear,

• liner fracture.43

During non-robotic THA surgeons may have difficulty visualizing the relationship of the acetabulum

to the pelvis and to the functional axis of the body through its spino-pelvic dynamics.44

Additionally,

they may not visualize the inner contour of the femur that affects the anteversion of the cementless

stem.45

As discussed below, Mako Robotic-Arm assisted procedures may help to overcome the

technical challenges associated with non-robotic total hip arthroplasty procedures. 10-12,18,45,46

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Dislocations

• Patients have experienced a reduction in dislocations with robot-assisted THA. In a recent study

evaluating patients undergoing posterior-approach total hip arthroplasty, individuals undergoing

robotic-arm assisted THA experienced significantly fewer dislocations at 6 months compared to

those undergoing non-robotic THA (P<0.001).18

• Based on data prospectively collected on primary THAs, using robotic-arm assistance during

THA reduced early dislocation rates compared to conventional THA. 18,45

In this analysis, data

were reviewed for all THAs (n=200) conducted consecutively by one surgeon at a single

institution in 2011 and 2012. Results included:

o Lower dislocation rates—likely stemming from enhanced accuracy for both acetabular

abduction (AAB) and acetabular anteversion (AAV) in the patient group receiving robotic-

arm assisted surgery compared with non-robotic THA (0% vs 3%, p<0.05). 18 ,45

o Reduced blood loss in the patient group receiving robotic-arm assisted surgery

compared to non-robotic THA (p-value <0.0001). 18 ,45

o Higher modified Harris Hip scores and UCLA activity level at one year in the patient

group receiving robotic-arm assisted surgery compared with non-robotic THA. 18 ,45

Implant Stability

• Preservation of acetabular bone during primary THA is important to implant stability and

longevity. Eccentric or excessive acetabular reaming may result in many complications that lead

to subsequent THA revisions.46

In a matched-pair controlled study, robotic-arm assisted THA

allowed for the use of smaller acetabular cups in relation to the patient’s femoral head size

compared to conventional THA. The use of smaller acetabular cups resulted in greater

preservation of bone stock which supports implant stability and has been shown to help prevent

dislocation.46

Acetabular Cup Implantation

• Optimal positioning of the acetabular component promotes the long-term success of total hip

arthroplasty by reducing the rate of adverse outcomes, such as component wear and dislocation,

and ultimately a reduction in admissions and revisions. Robotic-arm assistance has

demonstrated a significantly greater percent of acetabular components placed in both

Lewinnek’s and Callanan’s safe zones.11

Recent studies have demonstrated that optimal

acetabular cup implantation in non-robotic cases is achieved less frequently than originally

believed.18,45

Orientation of the acetabular cup influences the risk of post-operative complications

following THA. Studies suggest that the optimal anteversion ranges from 0 to 30° and acceptable

inclination ranges from 30 to 50°.43

Cup angles that occur outside these optimal ranges increase

the risk of complications such as impingement, increased wear at bearing surfaces, and hip

dislocation.48

Furthermore, the amount of surgical experience does not appear to affect proper

cup orientation.4849

• A recent study revealed that the acetabular cup was positioned in an ideal range only 50% of the

time during traditionally performed procedures (non-robotic).43

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• In a study comparing non-robotic and robotic alignment techniques, 50 Mako Robotic-Arm

assisted THAs were matched to historical non-robotic THAs conducted between 2008 and

2012.11

One hundred percent (100%) of the Mako Robotic-Arm assisted THAs were placed

within an acceptable range for anteversion and inclination vs. only 80% (40/50) of the manually

aligned and implanted THAs. Similarly, 92% of the Mako Robotic-Arm assisted THAs were within

another generally accepted range (Callanan) vs. only 62% of non-robotic THAs.11

• In a multicenter study (n=119 Mako Robotic-Arm assisted THA cases), planned cup placement

was compared with cup orientation post-operatively. In 95% of cases, cup placements were

recorded to be within 5° of the surgical plan, demonstrating that Mako Robotic-Arm assistance

provides surgeons with improved measures to facilitate patient-specific planning.12

• In a 2015 multicenter study (n=1,980, 228 Mako Robotic-Arm Assisted and 1,752 non-robotic

THA procedures), robotic-arm assistance resulted in a significantly greater percent of

components placed within a recommended range than conventional, x-ray, and fluoroscopic

modalities (p <0.05).10

Clinical Efficacy Summary

In summary, the use of Mako in both UKA and THA procedures has demonstrated enhanced clinical

outcomes and durability through more accurate component positioning/alignment, bone

preservation, and the potential for decreased blood loss. This has led to revision rates lower than

previously reported in historic registry data, as well as higher patient satisfaction scores. Moreover,

many of the technical challenges and increased adverse events associated with non-robotic UKA

and THA have been shown to be reduced with the use of robotic-arm assistance.

The Economics of Mako

Joint disease, affecting 13.9% of adults’ aged 25 years and older, is associated with an extremely

high economic burden. More than 600,000 patients in the U.S. had a primary knee arthroplasty

surgery in 2010, or 1.9 per 1,000, and as previously mentioned, by 2030 this demand is projected to

increase over 600% to 9.6 procedures per 1,000. The demand for primary total hip arthroplasty is

estimated to grow by 174% to 1.6 procedures per 1,000.

Robotic-arm assistance enables surgeons performing UKAs to reduce variability, achieve more

accurate placement, and reduce revisions, as previously indicated (3.5% vs 0.4%, p=.004, Source:

OptumInsight claims data). It is important to note that a revision joint arthroplasty is much more

complicated and more costly than the initial operation. The following are results of an analysis of the

Medicare population in the U.S. (CMS IPSAF and OPSAF, 2012 to 2014):

• The average cost of a revision following a non-robotic primary knee replacement was greater

than $39,000;

• A revision subsequent to a robotic arm-assisted primary knee arthroplasty surgery was $22,941,

40% less expensive than a revision following a non-robotic knee arthroplasty procedure;

• This represents a significant cost savings (over $16,000 per procedure).

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Moreover, in the OptumInsight commercial population, robotic assistance is associated with lower

all-cause readmission rates for UKA procedures within 30 days (over 36% lower) and 90 days (over

16% lower). These reduced readmission rates, in addition to the lower average cost per readmission

for robotic-arm assisted UKA procedures, translates to:

• 40% lower readmission costs @ 30 days

• 66% lower readmission costs @ 90 days

Managing Costs for Patients Requiring Knee Arthroplasty by Incorporating Mako

Robotic-Arm

The PMPM spend for primary joint arthroplasty and associated readmissions (including revisions) is

approximately $3.50 to $4.00 PMPM in a typical commercial population, a significant line item that

Mako can assist in managing. Importantly, demographic trends project increases in osteoarthritis

and joint arthroplasty at levels that will require all stakeholders to consider tools like Mako. Such

tools can facilitate increased opportunity to provide patients with the right procedure (specific to their

joint disease) at the right time, within an episode of care that utilizes services that potentially reduce

UKA revision rates as well as subsequent TKA rates.

In a Medicare population (CMS IPSAF and OPSAF, 2012 to 2014), the cost of revision surgery

subsequent to a robotic arm-assisted knee arthroplasty procedure is 40% less expensive than a

revision following a non-robotic knee arthroplasty procedure ($22,941 for robotic-arm assisted vs.

$39,165 for non-robotic). Additionally, in the Medicare population (CMS IPSAF, 2012 to 2014) the

average length of stay was 1.1 days shorter for a revision surgery subsequent to a robotic arm-

assisted knee arthroplasty procedure than a revision following a non-robotic knee arthroplasty

procedure (2.2 vs. 3.3 days). Note: See Appendix for commercial and Medicare claims analysis methodology.

Robotic-Arm Assistance Can Change the Trajectory of Surgical Joint Interventionse

Robotic-arm assistance may allow surgeons to perform UKAs in some patients who traditionally

would have undergone a TKA, thereby resulting in a change in practice patterns and surgical setting

with a favorable cost impact (robotic UKAs cost $500 less than TKAs on average in a commercial

population). To the extent that approximately 5 to 21% of UKA candidates are undergoing TKAs13,14

in an inpatient setting, robotic-arm assistance can facilitate more accurate alignment with less

variation, a reduction in readmissions (notably revisions), as well as a shift to an outpatient setting,

leading to potential savings of $0.02 to $0.09 PMPM by 2020 in a typical commercial population

(OptumInsight data 2013 to 2015). Furthermore, if a 20% migration from inpatient to hospital

outpatient is realized, savings can increase to $0.30 PMPM by 2020.

e Analysis conducted by Baker Tilly using a database compiled by OptumInsight, Inc. (Eden Prairie, MN) comprising

claims generated by a national commercial health plan consisting of approximately 25 million members. Index cases incurred Jan. 2013 – Dec. 2013, revision cases incurred within 24 months of index procedure. This commercial data has not been blended with Medicare or Medicare Advantage data.

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The economic benefits are noteworthy. A review of commercial 2014 data showed an ALOS of 1.8

days for UKA with robotic-arm assistance versus 2.9 days for TKA. Moreover, as previously stated,

from the OptumInsight data analysis, the rate of revision following a UKA with robotic-arm assistance

is significantly lower than that of a non-robotic UKA (0.4% vs 3.5%, p=.004) in a large commercial

data set.e Additionally, a recent study showed using robotic-arm assistance in UKA procedures is

cost effective compared with non-robotic UKAs providing additional quality-adjusted life years

(QALY) and reduced costs in high volume centers.49

Impact on Innovative Reimbursement Models

April 1, 2016 commenced the Medicare Comprehensive Care Joint Replacement (CJR) model in the

U.S., otherwise known as bundled payments. Under CJR, participation is mandatory for 791

hospitals in 67 geographic areas. These hospitals are accountable for the quality and total Medicare

cost of care provided to Medicare fee-for-service beneficiaries for lower extremity joint arthroplasty

procedures and recovery within 90 days post hospital discharge. Similarly, commercial payers and

employers have been implementing bundled payments with hospitals on hip and knee arthroplasty

surgeries. For example, The Connecticut Joint Replacement Institute at St. Francis Hospital has

rolled out a bundled payment program with ConnectiCare, the Mayo Clinic implemented a bundled

payment for knee arthroplasty surgeries covered by Florida Blue, and Johns Hopkins participates in

the Employers Centers for Excellence Network which offers bundled payments to large U.S.

employers such as Walmart and Lowe’s.50

The quality and cost benefits described in this value summary may improve a hospital’s performance

in these bundled payment episodes, by potentially reducing those costs associated with

complications and adverse events as well as potentially improving quality composite scores for a

participating hospital. This projected improvement in quality and cost may further reduce the

episode cost for payers and employers.

Payer Coverage Considerations

The majority of payers consider robotic-arm assistance integral to the primary joint arthroplasty

surgical procedure and not separately or additionally reimbursed. Surgical procedures completed

with robotic-arm assistance should be consistent with existing payer coverage policies and current

payer contract rates for the primary surgical procedure. For example, as previously stated, the

UnitedHealthcare and Humana reimbursement policies on Robotic-Assisted Surgery do not provide

for additional reimbursement. However, the lack of incremental reimbursement should not prohibit

surgeons from using their professional discretion in deploying robotic-arm assistance.

Conclusion

Robotic-arm assistance is an innovative, cost effective solution for payers. The Mako Robotic-Arm

Assisted System enables surgeons to treat knee and hip conditions with greater predictability4,6,7,11

by allowing for more accurate component placement and reproducibility of both partial knee

arthroplasty and total hip arthroplasty. This technology can also have a positive impact on patients

by potentially reducing post-operative pain,4 decreasing adverse events,

6-8 and enhancing their

satisfaction with the joint replacement procedure.6

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With all factors pointing to an increase in the prevalence of joint arthroplasties, it is important to

identify technologies to help mitigate rising costs and reduce the overall economic burden of

osteoarthritis. Allowing surgeons access to this operating room technology gives surgeons a

valuable tool to potentially enhance outcomes, mitigate adverse events,6-8

and enhance the patient

experience.

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APPENDIX:

A summary of the commercial data sources and methods for the commercial claims analyses

used in this value summary.

Data Sources

The source for the Commercial data was derived from OptumInsight, Inc. comprising claims

generated by a national commercial health plan consisting of approximately 25 million members.

The date range of data used is 2013-2015.

Methods

Baker Tilly’s methodology used a retrospective review designed to provide a comparison of medical

claims between knee procedures with and without a robotic-arm assistance device. Identification of

the knee procedures was determined using the following procedural index events as listed in the

Current Procedural Terminology (CPT) and International Classification of Diseases Version 9 (ICD-

9) coding manuals. In order to differentiate between UKAs and TKAs, CPT’s were tracked from the

professional place of service through to their respective inpatient procedure for the commercial

population.

• Unicompartmental Knee Arthroplasty (UKA) is defined by CPT code 27446 and Total Knee

Arthroplasty (TKA) is defined by CPT code 27447.

• Robotic cases were determined using the ICD-9 procedure code of 17.41.

• Inpatient revisions were determined using ICD-9 procedure codes 81.54, 81.55 or 00.80-00.84.

Patient Age / Sex Distribution

Non-Robotic UKA Robotic-Arm Assisted UKA

Age Band Male Female Overall Male Female Overall

00-24 0% 0% 0% 0% 0% 0%

25-44 28% 72% 5% 57% 43% 2%

45-64 46% 54% 69% 45% 55% 69%

65-69 44% 56% 13% 56% 44% 11%

70-74 51% 49% 6% 57% 43% 7%

75-79 47% 53% 4% 43% 57% 5%

80-99 49% 51% 3% 57% 43% 5%

Overall 46% 54% 100% 48% 52% 100%

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A summary of the Medicare data sources and methods for the Medicare claims analyses used

in this value summary.

Data Sources

The Medicare data was derived from the Medicare Inpatient Standard Analytical File (IPSAF) and

the Medicare Outpatient Standard Analytical File (OPSAF) for calendar years 2012-2014.

Methods

Baker Tilly’s methodology used a retrospective review designed to provide a comparison of medical

claims between knee procedures with and without a robotic-arm assistance device. Identification of

the knee procedures was determined using the following procedural index events as listed in the

Current Procedural Terminology (CPT) and International Classification of Diseases Version 9 (ICD-

9) coding manuals.

• ICD-9 procedure code 81.54 with either DRG 461, 462, 469 or 470 was used to determine knee

procedures.

• Robotic cases were determined using the ICD-9 procedure code of 17.41.

• Inpatient revisions were determined using ICD-9 procedure codes 81.54, 81.55 or 00.80-00.84.

• Outpatient revisions were determined using CPT codes 27486 or 27487.

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12Elson L, Dounchis J, Illgren R, Marchand R, et al. Precision of acetabular cup placement in robotic integrated

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13Arno S, Maffei D, Walker PS, Schwarzkopf R, Desai P, Steiner GC. Retrospective analysis of total knee

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14Ghomrawi HM, Eggman AA, Pearle AD. Effect of age on cost effectiveness of unicompartmental knee

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desired hip length and offset following robotic THA. Poster presented at: 14th Annual Computer Assisted Orthopedic Surgery Meeting, June 18-21, 2014, Milan, Italy.

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18Illgen RL, Bukowski BR, Abiola R. Outcomes after primary total hip arthroplasty: manual compared with

robotic assisted techniques. 44th Annual Advances in Arthroplasty; Cambridge, MA. October 7-10 2014.

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19Nawabi DH, Conditt MA, Ranawat AS, et al. Haptically guided robotic technology in total hip arthroplasty: a

cadaveric investigation. Proceedings of the Institution of Mechanical Engineers, Journal of Engineering in Medicine. 2012;2273(3, pt h):302-309.

20Atesok K, Galos D, Jazrawi LM, Egol KA. Preoperative planning in orthopaedic surgery. Bulletin of the

Hospital for Joint Diseases. 2015;73(4):257-268. 12p.

21Plate JF, Mofidi A, Mannava S, et al. Achieving accurate ligament balancing using robotic-assisted

unicompartmental knee arthroplasty. Adv Orthop. 2013;1-6.

22Parvizi J, Mui A, Purtill JJ, Sharkey PF, Hozack WJ, Rothman RH. Total joint arthroplasty: when do fatal or

near-fatal complications occur? J Bone Joint Surg Am. 2007;89:27-32.

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arthroplasty: which type of artificial joint do patients forget? Knee Surg Sports Traumatol Arthrosc. 2015 November;1-6, 21.

24Buckwalter JA, Saltzman C, Brown T. The impact of osteoarthritis. Clin Orthop Relat Res. 2004;427:S6-S15.

25Felson DT. Osteoarthritis: new insights. The disease and its risk factors. Ann Intern Med. 2000;133(8, pt

1):635-646.

26Leopold SS. Minimally invasive total knee arthroplasty for osteoarthritis. N Engl J Med. 2009;360(17):1749-

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27Lawrence RC, Felson DT, Helmick CG, et al. Estimates of the prevalence of arthritis and other rheumatic

conditions in the United States. Arthritis Rheum. 2007;58(1, pt 2):26-35.

28Dillon CF, Rasch EK, Gu Q, Hirsch R. Prevalence of knee osteoarthritis in the United States: arthritis data

from the Third National Health and Nutrition Examination Survey 1991-94. J Rheumatol. 2006;33(11):2271-2279.

29 Hunter D, Schofield D, Callander E. The individual and socioeconomic impact of osteoarthritis. Nature

Reviews Rheumatology. 2014; 10:437-441.

30Barbour KE, Helmick CG, Theis KA, et al. Prevalence of doctor-diagnosed arthritis and arthritis-attributable

activity limitation-United States, 2010-2012. Morb Mortal Wkly. Rep. 2013;62(44):869-873.

31Carr AJ. Beyond disability: measuring the social and personal consequences of osteoarthritis. Osteoarthritis

and Cartilage. 1999;7(2):230-238.

32Murphy L, Hemlock CG. The impact of osteoarthritis in the United States; a population-health perspective: A

population-based review of the fourth most common cause of hospitalization in U.S. adults. Orthop Nurs. 2012;31(2):85-91.

33Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in

the United States from 2005 to 2030. Bone Joint Surg Am. 2007 April;89(4)780-785. doi: 10.2106/JBJS.F.00222.

34Bozic KJ, Kurtz SM, Lau E, Ong K, Vail TP, Berry DJ. The epidemiology of revision total hip arthroplasty in

the United States. J Bone Joint Surg Am. 2009;91(1):128-133. doi: 10.2106/JBJS.H.00155.

35Novitas LCD for total hip and knee arthroplasty citing the American Academy of Orthopaedic Surgeons

(AAOS) and the American Association of Hip and Knee Surgeons (AAHKS). Model Coverage Determination: Total Joint Arthroplasty.

36Callaghan JJ, O’Rourke MR, Saleh KJ. Why knees fail: lessons learned. J Arthroplast. 2004;19(4):31-34.

37Ng VY, Lustenberger D, Hoang K, et al. Preoperative risk stratification and risk reduction for total joint

reconstruction: AAOS exhibit selection. J Bone Joint Surg Am. 2013;95:e191-15.

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38White RE, Allman JK, Trauger JA, Dales BH. Clinical comparison of the midvastus and medial parapatellar

surgical approaches. Clin Orthop Relat Res. 1999;367:117-12275.

39Tria AJ, Coon TM. Minimal incision total knee arthroplasty. Clin Orthop Relat Res. 2003;416:185-190.

40Blyth M, Smith J, Jones B, MacLean A, Anthony I, Rowe P. A CT based comparison of accuracy of

unicompartmental knee arthroplasty (UKA) implant positioning with and without the aid of robotic surgical assistance. 13

th Annual CAOS Meeting, June 12-15, 2013, Orlando, FL, USA. (Blyth/Jones 2013a).

41 Citak M, Suero EM, Citak M, et al. Unicompartmental knee arthroplasty: is robotic technology more accurate

than conventional technique? The Knee. 2013;20(4):268-271.

42Coon T, Roche M, Pearle A, Dounchis J, Borus T, Buechel F, Bhowmik-Stoker M, Conditt M. Short to Mid

Term Survivorship of Robotic-Arm Assisted Unicompartmental Knee Arthroplasty; EFFORT 2016 Poster; 1-3 June; Geneva.

43 Callanan MC, Jarrett B, Bragdon CR, et al. The John Charnley Award: risk factors for cup malpositioning:

quality improvement through a joint registry at a tertiary hospital. Clin Orthop Relat Res. 2010;469(2):319-329

44 Lazennac JY, Boyer P, Gorin M, Catone Y, Rosseau MA. Acetabular anteversion with CT in supine,

simulated standing, and sitting positions in a THA patient population. Clin Orthop Relat Res. 2011; 469:1103-1109. doi 10.1007/s11999-010-1732-7.

45Illgen R. Robotic assisted THA: reduce outliers and predictable outcomes. 43rd Annual Course: Advances in

Arthroplasty; October 22-25, 2013; Cambridge, MA. (Illgen 2013b)

46Suarez-Ahedo C, Gui C, Martin TJ, Stake CE, et al. Preservation of acetabular bone stock in total hip

arthroplasty using conventional vs. robotic techniques, A Matched-Pair Controlled Study. In: Preceedings World Arthroplasty Congress; April 15-18, 2015; Paris, France.

47Malik A, Maheshwari A, Dorr LD. Impingement with Total Hip Replacement. J Bone Joint Surg Am.

2007;89:1832-1842.

48Reize P, Geiger EV, Suckel A, Rudert M, Wulker N. Influence of surgical experience on accuracy of

acetabular cup positioning in total hip arthroplasty. Am J Orthop. 2008;37(7):360-363.

49Moschetti WE, Konopka JF, Genuario JW, Rubash HE. Can robot-assisted unicompartmental knee

arthroplasty be cost effective? a markov decision analysis. J Arthroplasty. November 2015.

50Tomsic, M. “How Lowe’s Saves Money While Offering Employees Free Surgeries.” WFAE. March 2015.

MKOSYM-WP-4_11564

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The clinical and economic value of the Mako™ Robotic-Arm Assisted SystemSystem

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1.0 Executive summary . . . . . . . . . . . . . . . . . . . . . . . . . 4

2.0 Changing orthopaedic landscape and the future of healthcare reform . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2.1 Overview of osteoarthritis . . . . . . . . . . . . . . . . . . . . . 5

2.1.1 Epidemiology . . . . . . . . . . . . . . . . . . . . . . . . . 5

2.1.2 Burden of disease. . . . . . . . . . . . . . . . . . . . . . . 5

2.1.3 Approaches to treatment . . . . . . . . . . . . . . . . . . . 6

2.2 Future of healthcare reform . . . . . . . . . . . . . . . . . . . . 7

3.0 Mako product overview . . . . . . . . . . . . . . . . . . . . . . . 10

4.0 Clinical and economic value of Mako . . . . . . . . . . . . . . . 12

4.1 Enhance the patient experience of surgical care . . . . . . . . . 14

4.1.1 Potential benefi ts of the Mako System in partial knee arthroplasty. . . . . . . . . . . . . . . . . . . . . . . . . . 14

4.1.2 Mako System in total knee arthroplasty . . . . . . . . . . 17

4.1.3 Mako System in total hip arthroplasty . . . . . . . . . . . 18

5.0 How Mako differs from other robotic platforms . . . . . . . . . 22

6.0 Mako System return on investment (ROI) . . . . . . . . . . . . . 24

6.1 Overview of Mako System return on investment calculator . . . 29

7.0 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

This document is intended to provide useful information to payers, health care facilities, and health care providers to assess the economic value of Mako Robotic-Arm Assisted Surgery. The studies relied on in this document are of varying design, ranging from large controlled clinical studies to single-surgeon studies and cadaver studies. As a result of variations in study design, the robustness of the data arising from different studies may vary. The document includes descriptions of studies relied upon, and published sources are cited throughout. We encourage you to consult the cited publications.

About this document

Table of contents

The clinical and economic value of the Mako™ Robotic-Arm Assisted System

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Figure 2-1 Complications associated with knee and hip arthroplasty procedures that may lead to failure or need for revision . . . . . . . . . . . . . . . . . . . . 6

Figure 2-2 The Institute for Healthcare Improvement Triple Aim Initiative4 . . . . . . . . . . . . . . . . . . . 7

Figure 2-3 Payment taxonomy framework37 . . . . . . . . . . . . . 8

Figure 3-1 Mako Robotic-Arm Assisted System . . . . . . . . . . 11

Figure 3-2 The Mako program solution . . . . . . . . . . . . . . 11

Figure 4-1 Summary of clinical and economic value of Mako . . 12

Figure 4-2 Early post-operative pain (at day seven) (A) and American Knee Society Scores (at three months) (B) after Mako Partial Knee surgery vs manual PKA38. . . . . . . . . . . . . . . . . . . . . 15

Figure 4-3 Mako Robotic-Arm Assisted PKA patient satisfaction at two year follow-up39 . . . . . . . . . . 16

Figure 4-4 Potential benefi ts of the Mako System. . . . . . . . . 17

Figure 4-5 Potential clinical benefi ts of Mako total hip arthroplasty . . . . . . . . . . . . . . . . . . . . . . . 18

Figure 4-6 Acetabular cup placement within Lewinnek and Callanan safe zones for Mako Robotic-Arm Assisted total hip arthroplasty (A) and conventional total hip arthroplasty (B)41 . . . . . . . . . . . . . . . . . . 19

Figure 4-7 Post-operative outcomes at six month follow-up for patients receiving manual THA vs robotic-arm assisted THA showing improvement in all measures40,42,73 . . . . . . . . . . . . . . . . . . . . . . 21

Figure 6-1 Procedure volumes pre/post Mako install – class of 201218 . . . . . . . . . . . . . . . . . . . . . . 25

Figure 6-2 Mako Robotic-Arm Assisted destination program . . 26

Figure 6-3 Healthcare resource utilization for Mako vs manual procedures38 . . . . . . . . . . . . . . . . . . 27

Figure 6-4 Case study one20. . . . . . . . . . . . . . . . . . . . . 28

Figure 6-5 Case study two16 . . . . . . . . . . . . . . . . . . . . 28

Figure 6-6 Mako model overview. . . . . . . . . . . . . . . . . . 29

Figure 6-7 Model inputs screen . . . . . . . . . . . . . . . . . . 30

List of fi gures

The clinical and economic value of the Mako™ Robotic-Arm Assisted System

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Demand for knee and hip procedures will continue to rise:

• According to a recent study evaluating historical procedure rates and population projections by the United States (US) Census Bureau, the projected number of fi rst-time total knee replacements will increase by 673% by 2030, correlating with nearly 3.5 million procedures.1

• The demand for total hip replacements is also projected to dramatically increase by 2030. Over the next 15 years, the number of primary total hip replacements is projected to increase by 174%, or 572,000 procedures.1

• These dramatic increases will have a considerable impact on healthcare utilization, demand for orthopaedic surgeons, and the desire for technological advancements to optimize patient outcomes.1

1.0 Executivesummary

2.0 Changing orthopaedic landscape and the future of healthcare reform

The clinical and economic value of the Mako™ Robotic-Arm Assisted System

• Elective hip and knee procedures are very common and represent a sizeable proportion of the growing orthopaedic service line.1

• The Institute for Healthcare Improvement’s Triple Aim Initiative framework describes an approach to optimizing health system performance through enhancing quality of care and the patient experience.2-7

• Recently proposed mandated bundled payments for knee and hip procedures have the potential to considerably affect the orthopaedic surgical procedural landscape.8

• The Mako™ Robotic-Arm Assisted System offers a transformational shift in orthopaedic surgery by enabling surgeons to reduce variability within partial knee procedures9-12,38 and total hip procedures,13-14,40-42,45 potentially driving operational effi ciency and thereby enhancing the orthopaedic service line and improving market share and profi tability.15-21

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The clinical and economic value of the Mako™ Robotic-Arm Assisted System

2.1.1 Epidemiology

Osteoarthritis, the most common form of arthritis, affects more people than any other joint disease and is the most widespread cause of walking-related disability in people over the age of 65 years.22-24 Among adults 60 years and older in the United States, an estimated 37.4% have radiographic evidence of the condition.25

Osteoarthritis has been estimated to affect nearly 27 million adults in the United States (34%).26 With the aging of the US population, the number of affected adults with osteoarthritis is expected to increase substantially.27

2.1.2 Burden of disease

The morbidity associated with osteoarthritis is considerable, as 80% of patients report limitations of movement, with 25% having diffi culty performing major activities of daily living.28 While osteoarthritis-related symptoms such as physical pain affect patients’ quality of life, the burden of osteoarthritis extends far beyond to encompass the social and personal aspects of everyday functionality.29 In a survey of patients, six handicap measures (as defi ned by the World Health Organization) were evaluated in patients with osteoarthritis (OA), rheumatoid arthritis (RA) and low back pain (LBP).29 Across dimensions including emotional well-being, body image, and relationships, patients with osteoarthritis reported signifi cantly greater handicaps than patients with RA (P-values=0.03 to 0.0001) and similar handicaps compared to patients with LBP.29

The overall economic burden of osteoarthritis in the United States is estimated to be more than $60 billion per year, with job-related costs reaching as much as $13 billion per year.22 As the fourth-most common cause for hospitalization, a diagnosis of osteoarthritis is attributed to approximately 12 million ambulatory care visits and 85,000 emergency room visits per year.30 Osteoarthritis is the leading indication for joint replacement surgery; 905,000 knee and hip replacements were performed in 2009 at a cost of over $42 billion.30

2.1 Overview of osteoarthritis

Total knee and hip replacements equal $42 billion in annual hospital costs.30

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2.1.3 Approaches to treatment

Joint replacement surgery is a treatment consideration for patients who are non-responsive to initial therapy with continuing joint symptoms and pain, before there is prolonged and established functional limitation and severe pain.31

For patients who are candidates for total joint procedures, several surgical approaches are available, including total joint replacement procedures, partial joint arthroplasty, manual (traditional) and robotic-assisted techniques. While all surgery carries risk, total joint replacement procedures are major surgical undertakings, with the potential for complications to occur24 (Figure 2-1).

TKA and THA are associated with a challenging recovery period that may include post-operative pain, frequent physical therapy, the use of assisted devices for ambulation in the near term, and narcotic analgesics to manage pain in the months following the procedure.24

For the reasons outlined above and the uncertainty around clinical outcomes, patients in the United States may be hesitant to undergo these procedures, and may be watchfully waiting for more conservative surgical treatments to become available. Although many factors have been shown to infl uence the use of knee and hip arthroplasties, patient preferences play a role in these elective surgeries.32 A qualitative, focus-group study of ethnically- and age-diverse patients with knee osteoarthritis explored factors that patients considered to be important in their decision-making to undergo TKA. Among these patients, personal experience (positive and negative), expectations about surgery outcomes, fears (e.g., recovery time, complications), and interactions with physicians were all important decision-making factors. In addition, many patients in this study viewed surgical options as a last resort treatment.32

The clinical and economic value of the Mako™ Robotic-Arm Assisted System

Procedure Common Complications

Knee arthroplasty34 • Instability• Infection• Aseptic loosening• Mal-alignment

Hip arthroplasty35 • Early mechanical failures• Dislocation• Prosthetic failures (peri-prosthetic fracture, leg

length discrepancy)

Figure 2-1. Complications associated with knee and hip arthroplasty procedures that may lead to failure or need for revision

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Evolving healthcare reform initiatives are of growing importance amid concerns about providing care to increasing numbers of patients with chronic conditions. By 2019, an estimated 19.3% of the US gross domestic product will be devoted to healthcare.36 Healthcare delivery and payment systems in the US must fundamentally change to contain this spending while enhancing the quality of care.

The Institute for Healthcare Improvement (IHI) has circulated the Triple Aim as a basic framework for healthcare reform. Its three areas of focus are (Figure 2-2)4:

• Enhancing the patient care experience � Better care for individuals

• Enhancing the health of populations � Better health for populations

• Reducing per-capita costs of healthcare � Lower costs through improvement

2.2 Future of healthcare reform

The clinical and economic value of the Mako™ Robotic-Arm Assisted System

Figure 2-2. The Institute for Healthcare Improvement Triple Aim Initiative4

Better health for the

population

Better carefor individuals

Lower costthrough

improvement

Participating stakeholders of the Triple Aim Initiative include healthcare systems, hospitals, healthcare insurance companies, physicians and provider networks, public health agencies, social services groups, and community coalitions.2,3 In today’s healthcare market, hospital systems in particular are being guided by the Triple Aim Initiative. Enhancing the delivery of surgical care will aid tremendously in helping hospitals to enhance the experience of patient care and reduce healthcare costs.6

Given the changing environment in payer contracting, success with the Triple Aim Initiative may ultimately increase market share and profi tability for stakeholders. Surgical care currently accounts for an estimated 52% of hospital admission expenses in the US.3

In January 2015, the Centers for Medicare & Medicaid Services (CMS) announced that in partnership with the private sector, the Department of Health and Human Services (HHS) had initiated the testing and expansion of new healthcare payment models designed to enhance healthcare quality and reduce costs. CMS and HHS developed a framework that categorizes healthcare payment according to how providers receive payment to provide care (Figure 2-3).37

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To help drive the healthcare system toward greater value-based purchasing (rather than continuing to reward volume regardless of quality of care delivered) HHS has set a goal to have 85% of Medicare fee-for-service payments in value-based purchasing categories two through four by 2016 and 90% by 2018.

The clinical and economic value of the Mako™ Robotic-Arm Assisted System

Category 1:Fee-for-service – no link to quality

Category 2: Fee-for-service – link to quality

Category 3: Alternative payment models built on fee-for-service architecture

Category 4: Population-based payment

Des

crip

tio

n Payments are based on volume of services and not linked to quality or effi ciency.

At least a portion of payments vary based on the quality or effi ciency of healthcare delivery.

Some payment is linked to the effective management of a population or an episode of care. Payments are still triggered by delivery of care, but opportunities exist for shared savings or 2-sided risk.

Payment is not directly triggered by service delivery, so volume is not linked to payment. Clinicians and organizations are paid and responsible for the care of a benefi ciary for a long period (e.g., ≥1 year).

Figure 2-3. Payment taxonomy framework37

Value-based purchasing includes payments made in categories 2 through 4. Moving toward category 4 involves 2 shifts: (1) increasing accountability for both quality and total cost of care and (2) a greater focus on population health management as opposed to payment for specifi c services.

HHS hopes to achieve the above goal through investment in alternative payment models such as accountable care organizations, advanced primary care medical home models, new models of bundling payments for episodes of care, and integrated care demonstrations for benefi ciaries who are Medicare-Medicaid enrollees. HHS is working with private payers, including health plans in the health insurance marketplace and Medicare Advantage plans, as well as state Medicaid programs, to move in the same direction toward alternative payment models and value-based payment to providers and to meet or exceed the goals outlined above wherever possible.37

HHS is aligned with the Triple Aim Initiative, as evidenced by their recent announcement that CMS is proposing the 2016 Comprehensive Care for Joint Replacement (CCJR) model for bundled payments for hip and knee replacement procedures with follow-up care provided for 90 days post-discharge, in an attempt to rein in costs and enhance overall quality of care.8 The overall cost of care today is driven largely by high procedural costs and readmission rates. Nearly half of total

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The clinical and economic value of the Mako™ Robotic-Arm Assisted System

The CCJR model outlines three key hospital care quality measures (listed below) as a means to improve hospital services and ultimately meet the objectives of the Triple Aim initiatives:

1) Serious medical and surgical complications

2) Unplanned readmissions

3) Patient experience

This model will act as an incentive for higher-value care across the inpatient and post-acute care continuum, identifying care processes for higher quality and more effi cient service delivery. Treatment centers will be encouraged to adopt treatment delivery measures that improve patient-centered outcome measures and advance treatment paradigms.

joint replacement costs are related to post-acute care. Adoption of technologies that contain costs and enhance patient care through more effi cient surgical interventions will help to meet the primary objectives of the Triple Aim Initiative.2-6

Summary of 2016 Medicare Comprehensive Care for Joint Replacement model

• The 2016 CCJR model proposes bundling payment for hip and knee replacement surgeries with follow-up care provided for 90 days post-discharge.

• Under the new Medicare Parts A and B payment model in the proposed CCJR, acute care hospitals in 75 geographic areas will receive retrospective bundled payments for episodes of care for lower extremity joint replacement or reattachment of a lower extremity.

• The CCJR will be tested for a fi ve-year period from January 1, 2016 to December 31, 2020.

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Mako Robotic-Arm Assisted Surgery is an innovative, breakthrough solution for those suffering with debilitating pain of the knee or hip. Stryker’s market-leading implants enabled by the Mako Robotic-Arm Assisted System allow surgeons to treat knee10,12,38,43 and hip40-42,45

conditions with reproducible precision (Figure 3-1). This innovative technology allows more accurate component placement10-14 and helps to standardize the surgical process across users.38 Mako computer-assisted 3D planning and guidance afford surgeons pre-operative planning for implant size, position, and alignment, as well as intra-operative adjustments to optimize implant placement as compared to the pre-operative plan for PKA9,10,12 and THA14,45 (Figure 3-2).

Accurate component placement with Mako technology begins with patient-specifi c preoperative planning. This surgical intervention allows for detailed 3D pre-operative planning. Using the patient’s computed tomography (CT) scan, a 3D model is formed to allow the surgeon to determine the implant size, placement, and alignment for each patient’s particular anatomical and functional considerations. Real-time data are provided to surgeons and their surgical staff, allowing continual assessment of ligament tension throughout the range of motion and implant articulation, and helping to avoid inadvertent transection of vital structures. Surgeons are able to refi ne the surgical plan intra-operatively for enhanced soft tissue balance. The Mako System also enhances the surgical experience by providing visual, auditory, and tactile feedback during bone preparation, allowing for accurate placement of the implant while considering bone structure for both PKA10,12,38,43 and THA40-42,45 procedures. One study showed that patients are better able to “forget” their artifi cial joint in daily life following PKA surgery compared to patients with

3.0 Mako product overview

The clinical and economic value of the Mako™ Robotic-Arm Assisted System

The Mako Robotic-Arm Assisted System is at the forefront of providing patients and healthcare providers with an innovative technology that may help to meet the goals of recently proposed policy initiatives. Mako technology offers a transformational shift in orthopaedic surgery by enabling surgeons to reduce variability within partial knee9-12,38,43 and total hip procedures,13-14,40-42,45 thereby enhancing the orthopaedic service line.

Mako Robotic-Arm Assisted Surgery has the potential to be:

• Predictable: Designed to minimize the margin of error to allow for accurate component placement, and to enhance accuracy and reproducibility of both PKA10,12,38,43 and THA.40-42,45

• Transformative: Can help to transform orthopaedic practice and ultimately, patient care, and to deliver value to payers, surgeons, and patients.

Mako clinical research includes over 50 peer reviewed publications and more than 350 scientifi c abstracts accepted and presented worldwide

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The clinical and economic value of the Mako™ Robotic-Arm Assisted System

similar health status undergoing TKA, as demonstrated by better Forgotten Joint Scores reported by patients44 (Figure 4-4). Less blood loss has been associated with the use of Mako Robotic-Arm Assisted procedures,40,42 potentially eliminating the need for routine post-operative hemoglobin monitoring and post-procedure blood transfusions.transfusions.

Figure 3-1. Mako Robotic-Arm Assisted System

Figure 3-2. The Mako program solution

Enhanced planningPatient-specific pre-operative plan enables accurate implant sizing and positioning.10-12,14,45

Functional positioningSurgeon-controlled intra-operative adjustments can be made to optimize implant placements.42

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The Mako Robotic-Arm Assisted System helps to address the challenges in today’s changing orthopaedic landscape and healthcare environ ment in all three aspects of the Triple Aim Initiative (Figure 4-1).

4.0 Clinical and economic value of Mako

The clinical and economic value of the Mako™ Robotic-Arm Assisted System

Triple Aim Initiative Clinical Value of Mako

Improving the patient experience of care7

• Mako Partial Knee resulted in lower post-operative pain at day seven and more accurate implant placement than manual PKA in a randomized controlled trial.38

• Mako Partial Knee surgery resulted in 92% patient satisfaction at two years.39

• Early results showed less physical therapy was required for Mako Partial Knee patients than manual TKA patients to reach the same functional goals.46

• Mako Robotic-Arm Assisted THA resulted in higher Harris Hip Scores and higher UCLA Activity Scores at one year post-operative compared to manual THA at minimum one year follow-up.40

Improving the health of populations7

• Studies have shown Mako PKA to be two to three times more accurate and three times more reproducible than manual partial knee replacement.10-12

• In cadaveric studies, Mako Total Hip acetabular cup placement has been shown to be four times more accurate in achieving desired version and six times more accurate in achieving desired inclination than manual total hip arthroplasty (THA).13,14

• A cadaveric study has demonstrated excellent accuracy and precision with regard to planned cup position, leg length, and offset.14

Reducing the per capita cost of health care7

• May allow for more predictable implant selection due to patient-specifi c planning for robotic-assisted PKA and THA.

• Time-neutral for robotic THA when compared to manual THA in a single center study.41

• Potential for decreased blood loss.40,42

• Allows for more accurate component placement10-12 and helps to standardize the surgical process across users38 for robotic PKA

• Potential decrease in sterilization costs due to fewer trays needed (fi ve trays in manual PKA vs two trays in Mako PKA).

Figure 4-1. Summary of clinical and economic value of Mako

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The clinical and economic value of the Mako™ Robotic-Arm Assisted System

Figure 4-1 (continued). Summary of clinical and economic value of Mako

Predictable Transformative

• May allow for more predictable implant selection due to patient-specifi c planning for Robotic-Arm Assisted PKA and THA.

• Robotic-Arm Assisted hip replacement was time-neutral compared to manual procedures in a single center study.41

• Decreased healthcare utilization for robotic PKA in terms of bed-days saved,38 visits to GP,38 and revision rates at two years.39

• Showed less physical therapy was required for Mako Robotic-Arm Assisted PKA patients than manual TKA patients to reach the same functional goals.46

• A randomized controlled study across users at a single center showed accurate and standardized results across users for robotic PKA.38

• Potential decrease in sterilization costs due to fewer trays needed (fi ve trays in manual partial knee replacement vs two trays in Mako PKA).

• May allow for more predictable implant selection due to patient-specifi c planning for Mako Robotic-Arm Assisted PKA and THA.

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The clinical and economic value of the Mako™ Robotic-Arm Assisted System

4.1 Enhance the patient experience of surgical care

Mako Robotic-Arm Assisted Surgery offers value through clinical, operational, and strategic benefi ts to surgeons, patients, and hospitals. The comprehensive clinical research on Mako Robotic-Arm Assisted Surgery is focused on providing evidence of the clinical, functional, and economic value of the Mako Robotic-Arm System and corresponding partial knee and total hip implant systems, as well as laying a scientifi c foundation for the support and development of future products and applications.

4.1.1 Potential benefi ts of the Mako System in partial knee arthroplasty

4.1.1.1 Component positioning

In addition to Stryker’s complete continuum of market-leading implants, Stryker offers a robotic technology for joint arthroplasty which may potentially enhance component positioning, even for more challenging PKA surgical procedures.47 Partial knee resurfacing for patients with osteoarthritis isolated to only one or two compartments spares the anterior and posterior cruciate ligaments (ACL and PCL, respectively) and healthy bone and tissue. Minimizing tissue disruption may enhance patient outcomes and recovery time after TKA procedures, thereby reducing the risk of complications and associated costs and hospital days.74,75 Manual partial knee can be demanding procedures with a restricted fi eld of view and surgeons cannot pre-operatively create a patient-specifi c plan. Poorly implanted PKA may fail earlier.38

Patellofemoral arthroplasty is among the most challenging of knee arthroplasty procedures due to the need to place components properly in multiple planes, and is often sensitive to even one millimeter of abnormality in implant depth. With manual instrumentation, it can be diffi cult to consistently restore tibial slope,48 coronal alignment, femoral rotation, and limb alignment49 (Figure 4-2).

Studies have shown Mako Robotic-Arm Assisted PKA procedures to be associated with two to three times less variability and error compared to manual procedures and results that are closely aligned with the pre-operative plan, allowing for greater accuracy with respect to magnitude of tibial slope, degree of error in the coronal plane, and femoral component placement.9-12,43,50

• A single-surgeon study demonstrated that Mako Robotic-Arm Assisted PKA allows for accurate and precise reproduction of ligament balance using dynamic, real-time soft-tissue balancing to help restore more natural-like knee kinematics.43 Even in the fi rst 50 patients (20 knees) who received medial PKA with Mako Robotic-Arm Assisted bone preparation from a single surgeon, good implant alignment was achieved during what was considered to be a learning phase associated with performing the procedure.10

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The clinical and economic value of the Mako™ Robotic-Arm Assisted System

• In a retrospective comparison of patients who underwent Mako PKA (n=31 patients) with patients who underwent manual PKA (n=27 procedures) by the same surgeon, tibial component alignment was found to be more accurate and less variable for Mako Robotic-Arm Assisted surgeries compared to those with manual instrumentation.12

Similar fi ndings were seen in a study of 12 cadaver knees; Mako PKA demonstrated more accurate alignment compared to manual technique.9

4.1.1.2 Outcomes for partial knee arthroplasty

Accurate alignment during surgery may result in enhanced outcomes and patient functioning. In a prospective, randomized, controlled single-center blinded trial (n=139 patients), surgeons using the Mako Robotic-Arm Assisted PKA achieved the preoperatively planned implant placement more frequently with respect to all measured parameters except tibial varus/valgus (femur varus/valgus, femur fl exion/extension, femur internal/external rotation, tibia fl exion/extension, tibia internal/external rotation) than when doing manual PKA surgery.38

In this same trial, Mako Robotic-Arm Assisted PKA resulted in signifi cantly lower post-operative pain and greater functionality at three months following surgery compared with manual PKA.38 Patients reported signifi cantly less pain at seven days post-operation (Figure 4-2) and greater functioning at three months post-operation, as measured by American Knee Society Scores >160 (excellent) (Figure 4-2). Offi ce visits to general practitioners and hospitalizations within 3 months of surgery were also lower for Mako Robotic-Arm Assisted PKA patients (offi ce visits: 30% vs 45%; hospitalizations: 3% vs 8%).38 Use of Mako PKA procedures translated into 54 bed-days saved per 100 patients.38

Figure 4-2. Early post-operative pain (at day seven) (A) and American Knee Society Scores (at three months) (B) after Mako PKA vs manual PKA38

MAKOplasty UKA (RESTORIS® MCK)

57%

60%

50%

40%

30%

20%

10%

0%Manual UKA

(Oxford®)

Med

ian p

ain

VA

S sc

ore

0-1

00

31%

60 MAKOplasty UKA (RESTORIS MCK)Manual UKA (Oxford®)

p<0.0550

70

40

30

20

10

00 1 2 3 4 5 6 7 14 21 28 35 42 49 56 63 70 77 84 91

Days post-operative

Early post-operative pain after PKA

% patients with excellent American Knee Society score (>160) at 3 months

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In summary, the use of the Mako System has demonstrated positive outcomes through more accurate component positioning,38 high patient satisfaction, and revision rates lower than previously reported historic registry data.39,52,53

Low revision rates are evidence of positive outcomes and low failure rates for Mako Robotic-Arm Assisted PKA patients. In a large multicenter retrospective study of six surgeons (n=797 patients; 909 knees), Mako PKA procedures had a cumulative revision rate of 1.2% at two years as well as high patient satisfaction at an average of 29.6 months follow-up (range: 22-52).51 This revision rate is substantially lower than reported rates for manual PKA of 4.5% and 4.8% at a two-year follow-up (Swedish and Australian national registries, respectively).52,53

At the two-year follow-up, most (92%) patients indicated that they were either very satisfi ed or satisfi ed with their Mako PKA procedure (Figure 4-3).39

The clinical and economic value of the Mako™ Robotic-Arm Assisted System

Figure 4-3. Mako Robotic-Arm Assisted PKA patient satisfaction at two year follow-up39

MAKOplasty UKA RESTORIS® MCK Onlay

1.1%

6

5

4

3

2

1

0

4.5%

Historical UKA Comparators

4.8%

All UKA Revisions Swedish Registry2

All UKA Revisions Australian Registry3 Mako PKA patient satisfaction %

Very Satisfied

Satisfied

Neutral

Dissatisfied

Very Dissatisfied

Per

cent

Rev

isio

n R

ate

0% 10% 20% 30% 40% 50% 60% 70% 80%

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4.1.2 The Mako System in total knee arthroplasty

The Mako Robotic-Arm Assisted System is indicated for use with the market-leading Triathlon Total Knee System. Stryker is excited about the Mako Total Knee and our plans to bring this truly differentiated technology option for Triathlon TKA to our customers. In combination with use in PKA and THA, the TKA makes the Mako System a comprehensive total joint arthroplasty technology for a provider’s orthopaedic service line. The total knee application utilizes Stryker’s Mako integrated cutting system (MICS). The MICS powers a Stryker saw blade designed specifi cally for the Mako platform. This is the same hand piece that enables robotic-arm assisted acetabular reaming with the Mako Total Hip. Based on data from validation testing and a safety focused clinical trial, the Mako Total Knee performed within the intended use and met the primary clinical endpoints.

The clinical and economic value of the Mako™ Robotic-Arm Assisted System

Figure 4-4. Potential benefi ts of the Mako Robotic Arm System

Patient-specifi c pre-operative planning

• Using the patient’s CT scan, a 3D model is created to plan implant size, placement, and alignment specifi c to each patient’s unique anatomy.

Intra-operative soft-tissue balancing

• Surgeons are provided with real-time data, enabling assessment of ligament tension throughout range of motion and implant articulation.

• This enables surgeons to fi ne-tune the plan intra-operatively, if needed, for soft-tissue balance.

Robotic-Arm Assisted resection

• The Mako System offers visual, auditory, and tactile feedback during bone preparation to help ensure accurate implant fi t.

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4.1.3 Mako System in total hip arthroplasty

4.1.3.1 Component positioning (stability and dislocation)

Many reasons for revision THA can be linked to malpositioned acetabular components including dislocation, impingement, component wear, and liner fracture.54 In a recent study evaluating patients undergoing posterior-approach THA, individuals receiving manual THA experienced signifi cantly more dislocations at six months compared to those undergoing Robotic-Arm Assisted THA (P<0.001).40,42 A recent study performed at an academic tertiary referral center revealed that the acetabular cup was positioned in an optimal range for both abduction and version range only 50% of the time during manually performed procedures.54 This study suggested that the optimal anteversion ranges from 0° to 30° and acceptable inclination ranges from 30° to 50°.54 Cup angles that stray outside these optimal ranges increase the risk of complications such as impingement, increased wear at bearing surfaces, and hip dislocation.56 Interestingly, surgical experience does not appear to affect proper cup orientation. Mako Robotic-Arm Assisted procedures may enable surgeons to more accurately plan and place components, potentially reducing variability within the THA procedure (Figure 4-5).13-14,40-41,57

The clinical and economic value of the Mako™ Robotic-Arm Assisted System

Figure 4-5. Potential clinical benefi ts of Mako Total Hip Arthroplasty

Predictable Transformative

• In cadaveric studies, Mako Total Hip acetabular cup placement has been shown to be four times more accurate in achieving desired version and six times more accurate in achieving desired inclination than manual THA.13,14

• A cadaveric study has shown robotic THA provides excellent accuracy and precision with regard to planned cup position, hip length, and offset.14

• A matched-pair controlled study determined greater bone stock preservation with robotic THA vs manual THA.58

• Increased accuracy and reduced dislocation rates vs manual THA.40,42

• Potential for decreased blood loss.40,42

• Mako Robotic-Arm Assisted THA resulted in higher Harris Hip Scores and higher UCLA Activity Scores compared to manual THA at minimum 1-year follow-up.40

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In a study conducted between 2008 and 2012 comparing THA using manual alignment techniques with THA using Mako Robotic-Arm Assisted alignment, Mako Robotic-Arm Assisted THAs were matched to historical manual THAs.41 As shown in Figure 4-6, 100% of the Mako THAs were placed within the Lewinnek safe zone for anteversion and inclination vs 80% (40/50) of the manually aligned and implanted THAs. Similarly, 92% of the Mako Robotic-Arm Assisted THAs were within the Callanan safe zone vs only 62% of manual THAs (Figure 4-6).41

Similar fi ndings were observed in both live patient studies and cadaver investigations:

• In a multicenter center study (n=119 Mako THA cases), planned cup placement was compared with cup orientation after impaction and post-operatively. In 95% of cases, cup placements were recorded to be within 5° of the surgical plan, demonstrating that Mako Robotic-Arm Assisted Surgery is designed to facilitate patient-specifi c planning.57

• In a cadaveric investigation, 12 acetabular components were implanted into six cadaveric pelvises: Mako Robotic-Arm Assisted THA on one side and manual THA on the other side. Hips implanted with the Mako Robotic-Arm had four to six times greater accuracy in version and inclination vs manual THA: the root mean squared error for manual implantation was fi ve times higher for cup inclination and 3.4 times higher for cup anteversion.13

The clinical and economic value of the Mako™ Robotic-Arm Assisted System

Inclination

30.0

Robotic THALewinnek safe zone

Callanan safe zone

A35.0

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Figure 4-6. Acetabular cup placement within Lewinnek and Callanan safe zones for Mako Robotic-Arm Assisted total hip arthroplasty (A) and conventional total hip arthroplasty (B)41

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4.1.3.2 Potential to restore leg length and hip biomechanics (offset)

Manual THA may lead to discrepancies in leg length following surgery. A study examined two methods of intraoperative leg length assessment and found that a discrepancy of less than fi ve millimeters was achieved in only 73% and 67% of patients for the two methods individually, with more than 25% of patients having a leg length discrepancy of more than fi ve millimeters regardless of which manual surgical method was used.60 Another study by Manzotti et al. found that at 6 months post-op, the mean postoperative leg length discrepancy was reduced to 5.06 mm (range: 0–12) in the computer-assisted group, compared to 7.64 mm (range: 0–20) in the freehand group61 Harris hip scores post-THA have been reported to be signifi cantly higher in patient groups in which femoral offset was normal or increased relative to the contralateral side.62 Use of Mako THA has demonstrated greater accuracy in achieving desired leg length compared with manual THA based on a cadaveric investigation of 21 hips.14 In this study, the resulting hip length was 1.6 ± 1.2 mm, demonstrating excellent accuracy and precision with regard to planned cup position, hip length, and offset.14

4.1.3.3 Allowance for preservation of acetabular bone stock

Preservation of acetabular bone during primary THA is important since proper implant stability and longevity depend largely on the amount of bone stock left after acetabular reaming. Eccentric or excessive acetabular reaming may lead to soft tissue impingement, loosening, altered center of rotation, bone-to-bone impingement, intraoperative periprosthetic fracture, early implant failure due to lack of bone ingrowth, and other complications, potentially leading to subsequent revision of THA.58 In a matched-pair controlled study, the size of the acetabular cup relative to that of the femoral head was used as a surrogate measure of acetabular bone resection. In this study, Mako Robotic-Arm Assisted THA allowed for the use of smaller acetabular cups in relation to the patient’s femoral head size compared to conventional THA, indicating greater preservation of bone stock.58

4.1.3.4 Outcomes for total hip arthroplasty

Based on data prospectively collected on primary THAs conducted since August 2000 from a single institution, Mako Robotic-Arm Assisted THA enhanced accuracy and reproducibility of component placement and reduced early dislocation rates compared to conventional THA as discussed above.40,42 In this analysis, data were reviewed for all THAs (n=300 patients) conducted by one fellowship-trained surgeon at a single institution over three time periods in order to compare surgical outcomes:40,42

The clinical and economic value of the Mako™ Robotic-Arm Assisted System

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The clinical and economic value of the Mako™ Robotic-Arm Assisted System

In summary, use of the Mako System has demonstrated positive outcomes by allowing for more accurate component positioning,40-42

and bone preservation.58

• Group one (2000 to 2001): First 100 consecutive manual THA cases conducted

• Group two (2011): Last 100 consecutive manual THA cases conducted

• Group three (2011 to 2012): First 100 consecutive Mako THA cases conducted

As shown in Figure 4-7, Mako Robotic-Arm Assisted THA demonstrated greater accuracy for both acetabular abduction (AAB) and acetabular anteversion (AAV) and demonstrated lower dislocation rates at 1 year compared with manual THA.40,42,73 The average estimated blood loss was also reduced in the patient group receiving robotic-arm assisted surgery compared to manual THA.40,42

First 100 manual THA cases

Last 100 manual THA cases

First 100 Total Hip cases

Early dislocation rate (within fi rst 12 months post-op)

5% 3% 0%

Limb length discrepancy >15mm 9% 1% 1%

Estimated blood loss 533cc 437cc 357cc

Acetabular linear fracture rate 3% 0% 0%

AAB in target zone 66% 91% 98%

AAV in target zone 40% 48% 76%

AAB and AAV in target zone 31% 45% 75%

Figure 4-7. Post-operative outcomes at six month follow-up for patients receiving manual THA vs Robotic-Arm Assisted THA showing improvement in all measures40,42,73

In this same study, while excellent clinical outcomes were noted for both Mako Robotic-Arm Assisted THA and manual THA at a one year clinical follow-up, patients who had received Mako Robotic-Arm Assisted THA demonstrated signifi cantly higher modifi ed Harris Hip scores and UCLA activity level compared with manual THA.40,42

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The Mako System possesses several key features that make it unique to the robotic surgery environment. It utilizes 3D scanning and segmentation to allow the surgeon to determine implant size, placement, and alignment that best suits each patient’s anatomy. Intraoperative gap balancing is used to obtain symmetric and balanced fl exion and extension gaps in knee surgery. Stereotactic guidance from the Robotic-Arm provides visual, auditory, and tactile feedback during bone preparation to enhance the surgical experience.

The Mako System differs substantially from other robotic technology currently available on the market. For example, the da Vinci Surgical System is a remote tele-manipulator system. The surgeon sits at a console while viewing a magnifi ed image of the patient’s body. A surgeon is actively dissecting/ cutting/cauterizing/suturing in real time.63-66 In contrast, the Mako System has the capability to virtually create the pre-operative plan before an incision is made, and is therefore virtual, editable, and without patient consequence prior to the start of the surgery. The surgeon creates and analyzes the pre-operative plan in 3D before surgery and bone resection even begins. The Mako System is designed to promote precise, consistent, and reproducible execution of this pre-operatively approved plan.9,10,12,14,45

The Mako System has a planning tool that does not cut bone until a thorough surgical plan is created and approved by the surgeon. The implant position, tracking, and soft tissue balancing are assessed in a virtual 3D model by combining a CT and intra-op bone registration. A CT scan uses a combination of 2D and digital geometry processing to generate a 3D image of the body. While plain fi lm radiographs (x-rays) provide a 2D image of the scanned area, anatomic structures may overlap creating an image which is less detailed than a CT scan. In a CT image, overlapping structures are eliminated, making the internal anatomy easier to visualize. In knee and hip arthroplasty procedures, the femoral version and tibial torsion76 can provide critical guidance when planning a case. Bony anatomic landmarks of the femur and tibia can be clearly identifi ed using 3D imaging technologies. After a surgeon pre-plans the implant position, the Robotic-Arm is introduced to the surgical site. The arm uses stereotactic controls (visual, auditory, and tactile) to help ensure only the desired bone is resected. The Robotic-Arm will give resistance, an audible warning, and ultimately turn off if the cutting tool on the Robotic-Arm varies too far from the pre-operative plan.

5.0 How Mako differs from other robotic platforms

The clinical and economic value of the Mako™ Robotic-Arm Assisted System

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The clinical and economic value of the Mako™ Robotic-Arm Assisted System

A study by Jinnah et al. quantifi ed the learning curve of robotic-assisted PKA. A total of 892 patients received a PKA performed by 11 different surgeons with the Mako system. Each surgeon had performed at least 30 surgeries with this new technology, and the surgical time of the fi nal 20 surgeries of each surgeon was averaged to defi ne a steady state surgical time. The study measured the number of surgeries required to obtain two consecutive and three total surgeries completed within the 95% confi dence interval of the steady state surgical time of that particular surgeon. Results showed that the number surgeries required to have three surgeries completed within the 95% CI of the steady state surgical time was only 13 (range: 5 to 29), and the number required to have two consecutive surgeries within this same time frame was 16 (range: 4 to 42).67

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Over 200 Mako Robotic-Arm Assisted Systems are being used to perform surgery today. To date, over 50,000 robotic hip and knee surgeries have been performed with the system. Over 700 orthopaedic surgeons use the technology in practice and over 1,500 surgeons have attended training classes.

The clinical and economic value of the Mako™ Robotic-Arm Assisted System

6.0 Mako System return on investment (ROI)

Mako Robotic-Arm Assisted Surgery offers a transformational shift in orthopaedic practice, and, ultimately patient care, through delivering value to payers, surgeons and patients.

The potential surgical and patient-related benefi ts of the Mako System may translate to positive economic gains to institutions that adopt this technology:

• Has demonstrated a relatively short procedural learning curve for PKA and THA67,68

• Allows for more accurate implant placement in PKA relative to pre-operative plan50

• Potential decrease in sterilization costs due to fewer trays needed (fi ve trays in manual PKA vs two trays for Mako PKA)

• Potential for reduced post-operative health resource utilization38,39,46

– Potentially decreased length of hospital stay following Mako PKA procedure vs manual partial knee (1.7 days for Mako PKA vs 2.3 days for conventional manual procedure),70 and a quicker time to discharge resulting in a total of 54 bed days saved per 100 patients38

Mako System installations 2006 through 2015

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2010

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rage

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ual p

roce

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+2.8%

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–6.9%

–6.8%

Isolation of 34 currently active Mako systems installed in 2012. Active is defined as having performed at least one procedure with the MAKO system during 2012 and 2013. Overall hospital orthopaedic procedure provided by Aileron Solutions, 2010 to 2013

The clinical and economic value of the Mako™ Robotic-Arm Assisted System

– Early results showed less physical therapy was required for Mako Robotic-Arm Assisted Partial Knee patients than manual TKA patients to reach the same functional goals.46

– Studies have demonstrated a cumulative revision rate of 1.2% at an average of 29.6 months follow up compared to 4.5% at a two-year follow-up reported in the Swedish national registry.39,51,52

– A single surgeon, single institution study of 300 patients demonstrated lower dislocation rates at one year compared with manual THA (0% for Mako Robotic-Arm Assisted vs 5% for the fi rst 100 cases and 3% for the last 100 cases).40,42

• May expand market share and framework of orthopaedic service line,16-17,19-21 with potential for halo effect growth16,17,20 and surgeon recruitment – Increased market growth for hospitals performing Mako

Robotic-Arm Assisted procedures: sites with Mako Systems installed in 2012 showed average annual increases of 11.3% for hip procedures and 22.1% for knee procedures after Mako Systems were installed18 (Figure 6-1).

• Case studies have shown a potential for an increase in the number of Mako Robotic-Arm Assisted and conventional knee procedures:16,17 – One hospital showed a 32% increase in conventional knee

arthroplasties two years after adoption of Mako Robotic-Arm Assisted procedures, and a 77% increase in primary knee arthroplasties16

– Another hospital showed a 131% increase in all primary knee arthroplasties, and a 14% increase in total knee arthroplasty in the year following implementation of Mako Robotic-Arm Assisted procedures17

Figure 6-1. Procedure volumes pre/post Mako install – class of 201218

Procedure volumes pre/post Mako install – class of 2012

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The clinical and economic value of the Mako™ Robotic-Arm Assisted System

– A 571-bed community hospital experienced 14% increase in TKA. In addition, PKA volume more than tripled, and in the second full year following Mako System implementation, experienced a 22% increase in Mako Partial Knee20

– Finally, another community hospital experienced a 10-fold growth in PKA procedures and a 14% market share growth for all DRG 470 procedures in the fi rst year following adoption of the Mako technology15

• There is anecdotal evidence to suggest implementation of the Mako System within a local institution may create a competitive advantage to stop patient leakage to large metropolitan hospitals21

The Mako Robotic-Arm Destination Program is committed to collaborating with facilities that have the Mako System to offer marketing and strategy expertise, best practices, and marketing tools to generate consumer and professional awareness and to promote patient growth and growth of market share. The Mako Robotic-Arm Assisted Destination Program provides facilities with a detailed plan and materials that target internal teams, key hospital stakeholders, consumers, and referring physicians. Stryker is committed to helping customers establish a concrete market advantage.

Strategic consultingLend marketing expertise and best practices that focus on your market dynamics and osteoarthritis treatment plans

Planning and developmentOffer planning and program management tools and support in crafting an effective marketing plan

Execution advice Provide a marketing toolkit and resources to facilitate implementation

Figure 6-2. Mako Robotic-Arm Destination Program

The Mako System technology offers potential opportunities for downstream cost avoidance consistent with the Triple Aim Initiative.

• The Mako System technology has demonstrated a shortened length of hospital stay for Robotic-Arm Assisted PKA compared with manual PKA procedures in a retrospective review of 125 patients who received lateral PKA (2.3 vs 1.7 days for knee procedures).70

• In addition, Mako Partial Knee has been shown to reduce early post-operative healthcare utilization compared to manual PKA (fewer general practitioner visits and quicker time to discharge) within three months post-operation (Figure 6-2).38

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The clinical and economic value of the Mako™ Robotic-Arm Assisted System

Figure 6-3. Healthcare resource utilization for Mako vs manual procedures38

Hospital bed days(time to discharge)

Post-operative GP visits(proportion of patients visiting GP within 3 months of surgery)

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• The ability to avoid or reduce revisions would represent cost savings both to society and in institutions with bundled payment programs if revisions occur within the defi ned episode of care. Although the incidence of failure after knee replacement is low, it has been reported that approximately 11.8% of early TKA revisions are due to inaccuracies experienced during surgery (e.g., mal-alignment or mal-position).71 Mako Partial Knee procedures had a low cumulative revision rate of 1.2% at an average 29.6 month follow-up compared with the reported registry rates for manual PKA of 4.5% and 4.8% at a two-year follow up (Swedish and Australian national registries, respectively).51,52,53 From the perspective of the healthcare system, this may represent a substantial reduction in the costs of joint replacement surgery, as the average revision arthroplasty has been estimated to cost $54,553.72

There are numerous examples of hospital successes. Clinical studies of Mako Robotic-Arm Assisted procedures have demonstrated high to very high levels of satisfaction in PKA39 and enhanced function in THA40,42 following their surgery. Such positive experiences associated with Mako System-equipped facilities may further increase procedural volume and expand orthopaedic programs. Preliminary market trend data show that sites that have implemented Mako technology on average outperform market growth, leading to an earlier ROI than originally estimated.15-21

Hospitals that have adopted the Mako System technology have been able to demonstrate increased market reach and surgical volume while growing fi nancial returns. In a recent large community hospital case, Mako technology demonstrated year-over-year growth. In year two, there was 22% growth in Mako Partial Knee procedures, with PKA surgeries more than tripling, and a halo effect of 14% growth in TKA.20

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The clinical and economic value of the Mako™ Robotic-Arm Assisted System

Pre-MAKOplasty 1 yearpost-MAKOplasty

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Figure 6-4. Case study one20

A recent case study16 demonstrated that use of the Mako System was associated with substantial growth in the number of joint procedures. There was a 32% increase in conventional knee arthroplasty procedures (from 335 to 443 procedures), and a 77% increase in the number of primary knee arthroplasty procedures (from 335 to 592 procedures). (Figure 6-4).16

Figure 6-5. Case study two16

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The clinical and economic value of the Mako™ Robotic-Arm Assisted System

Stryker has developed a customizable tool that can assist each plan or facility in assessing their ROI in the Mako Robotic-Arm Assisted System. An overview of the tool is provided in this section. The full tool is available from Stryker upon request. The purpose of the calculator is to estimate the ROI for hospitals with the adoption of the Mako Robotic-Arm Assisted System (Figures 6-6 and 6-7).

6.1 Overview of Mako System return on investment calculator

Figure 6-6. Mako model overview

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The clinical and economic value of the Mako™ Robotic-Arm Assisted System

Inputs into the ROI calculator include specifi cation of individual surgeon procedural volumes, yearly growth estimates, percent conversion from manual to robotic procedures, and reimbursement and payer mix. Key health resource utilization variables such as hospital length of stay, cost of sterilization trays, and revision rates are also included. The model is fl exible and allows for inputs to be tailored to your facility’s unique needs. A sensitivity analysis can also be performed to determine which variables have the largest overall impact on the ROI.

Figure 6-7. Model inputs screen

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1. Kurtz AAOS_Total Knee and Hip Replacement Projections 2030. http://www.prnewswire.com/news-releases/total-knee-and-hip-replacement-surgery-projections-show-meteoric-rise-by-2030-55519727.html. Accessed June 24, 2015.

2. Stiefel, M.& Nolan, K. A (2012). Guide to Measuring the Triple Aim: Population Health, Experience of Care, and Per Capita Cost IHI Innovation Series White Paper. Cambridge, MA: Institute for Healthcare Improvement.

3. Vetter, T. R., Boudreaux, A.M., Jones, K.A., Hunter, J.M., Pittet, J.F. (2014). The Perioperative Surgical Home: How Anesthesiology Can Collaboratively Achieve and Leverage the Triple Aim in Health Care, Anesthesia & Analgesia, 118(5); 1131-1136.

4. Whittington, J.W., Nolan K., Lewis N., Torres T. (2015). Pursuing the Triple Aim: The fi rst seven years. Milbank Quarterly. 93(2):263-300.

5. Cormier, J.N., Cromwell, K.D., Pollock, R.E. (2012). Value-based health care: a surgical oncologist’s perspective. Surgical Oncology Clinics of North America, 21:497-506.

6. Fry, D.E., Pine, M., Jones, B.L., Meimban, R.J. (2011). The impact of ineffective and ineffi cient care on the excess costs of elective surgical procedures. J AM Coll Surg. 212:779–86.

7. Institute for Healthcare Improvement Triple Aim Initiative. http://www.ihi.org/engage/initiatives/tripleaim/Pages/default.aspx. Accessed October 16, 2015.

8. Newmarker C. Why Change is Coming to Hip and Knee Replacements. Orthopedics, posted July 10, 2015.

9. Citak M, Suero EM, Citak M, Dunbar NJ et al. Unicompartmental knee arthroplasty: Is robotic technology more accurate than conventional technique? The Knee 2013; 20:268-271.

10. Dunbar NJ, Roche MW, Park BH, Branch SH; et al. Accuracy of Dynamic Tactile-Guided Unicompartmental Knee Arthroplasty. Journal of Arthroplasty. May 2012. 27(5): 803-808.e1.

11. Lonner, JH. Robotic-Arm Assisted Unicompartmental Knee Arthroplasty. Seminars in Arthroplasty. 2009. 20(1): 15-22.

12. Lonner JH, John TK, Conditt MA. Robotic Arm-Assisted UKA Improved Tibial Component Alignment: A Pilot Study Clin Orthop Relat Res. July 2010. 468(1):141-6.

13. Nawabi DH, Conditt MA, Ranawat AS, Dunbar NJ, et al. Haptically guided robotic technology in total hip arthroplasty: a cadaveric investigation. Journal of Engineering in Medicine 2012;227(3):302-309.

14. Jerabek SA, Carroll KM, Maratt JD, Mayman DJ, Padgett DE. Accuracy of Cup Positioning and Achieving Desired Hip Length and Offset Following Robotic THA.; 14th Annual CAOS Meeting, June 18-21, 2014, Milan, Italy.

15. DMC Huron Valley – Sinai Hospital, Commerce Township, MI. Stryker Orthopaedics Memo to File #1. October 15, 2015.

16. North Carolina Specialty Hospital, Durham, NC. Stryker Orthopaedics Memo to File #2. October 15, 2015.

17. Oconomowoc Memorial Hospital – Oconomowoc, WI. Stryker Orthopaedics Memo to File #3. October 15, 2015.

18. Pre-Post Mako System Installation Procedure Volumes – Class of 2012 Installations. Aileron Solutions, 2010-2013. Stryker Orthopaedics Memo to File #8. October 16, 2015.

19. St. Michael’s Medical Center – Newark, NJ. Stryker Orthopaedics Memo to File #5. October 15, 2015.

20. Holy Cross Hospital – Ft Lauderdale, FL. Stryker Orthopaedics Memo to File #6. October 15, 2015.

21. Mako Economic Case Profi le – One Year Review – Central Carolina Hospital. Stryker Orthopaedics Memo to fi le #7. October 15, 2015.

22. Buckwalter JA, Saltzman C, Brown T. The impact of osteoarthritis: implications for research. Clin Orthop Relat Res. 2004;(427 Suppl):S6-S15.

23. Felson DT, Lawrence RC, Dieppe PA, et al. Osteoarthritis: new insights. Part 1: the disease and its risk factors. Ann Intern Med. 2000;133(8):635-646.

7.0 References

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The clinical and economic value of the Mako™ Robotic-Arm Assisted System

24. Leopold SS. Minimally invasive total knee arthroplasty for osteoarthritis. N Engl J Med. 2009;360(17):1749-1758.

25. Dillon CF, Rasch EK, Gu Q, Hirsch R. Prevalence of knee osteoarthritis in the United States: arthritis data from the Third National Health and Nutrition Examination Survey 1991-94. J Rheumatol. 2006;33(11):2271-2279.

26. Lawrence RC, Felson DT, Helmick CG, et al.; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008;58(1):26-35.

27. Barbour KE, Helmick CG, Theis KA, Murphy LB, Hootman JM, Brady TJ, Cheng YJ. Prevalence of doctor-diagnosed arthritis and arthritis-attributable activity limitation-United States, 2010-2012. Morb Mortal Wkly Rep. 2013; 62(44): 869–873.

28. Centers for Disease Control and Prevention (CDC). Arthritis: Osteoarthritis. http://www.cdc.gov/arthritis/basics/osteoarthritis.htm. Accessed June 24, 2015.

29. Carr AJ. Beyond disability: measuring the social and personal consequences of osteoarthritis. Osteoarthritis Cartilage. 1999;7(2):230-238.

30. Murphy L, Helmick CG. The impact of osteoarthritis in the United States: a population-health perspective: A population-based review of the fourth most common cause of hospitalization in U.S. adults. Orthop Nurs. 2012;31(2):85-91.

31. National Institute for Health and Care Excellence (NICE). Osteoarthritis: care and management in adults [CG177]. http://www.nice.org.uk/guidance/cg177. Accessed June 24, 2015.

32. Suarez-Almazor ME; Richardson M, Kroll TL, Sharf BF. A Qualitative Analysis of Decision-Making for Total Knee Replacement in Patients with Osteoarthritis. J Clin Rheumatol. 2010 June;16(4):158-163.

33. Liddle AD, Judge A, Pandit H, Murray DW. Adverse outcomes after total and unicompartmental knee replacement in 101,330 matched patients: a study of data from the National Joint Registry for England and Wales. Lancet. 2014;384(9952):1437-1445.

34. Callaghan JJ, O’rourke MR, Saleh KJ. Why knees fail: lessons learned. J Arthroplasty. 2004;19(4 Suppl 1):31-34.

35. Tarwala R, Dorr LD. Robotic assisted total hip arthroplasty using the MAKO platform. Curr Rev Musculoskelet Med. 2011;4(3):151-156.

36. Sisko AM, Truffer CJ, Keehan SP, Poisal JA, Clemens MK, Madison AJ. National health spending projections: the estimated impact of reform through 2019. Health Aff. 2010;29:1933-1941.

37. Centers for Medicare and Medicaid Services Fact Sheet. Better Care. Smarter Spending. Healthier People: Paying Providers for Value, Not Volume. January 26, 2015. Accessed July 28, 2015 http://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-items/2015-01-26-3.html.

38. Blyth M, Jones B, MacLean A, Anthony I, Rowe P. Accuracy of UKA implant positioning and early clinical outcomes in a RCT comparing robotic assisted and manual surgery. 13th Annual CAOS Meeting, June 12-15, 2013, Orlando, FL, USA.

39. Coon T, Roche M, Pearle A, Dounchis J, Borus T, Buechel Jr F. Short to Mid Term Survivorship of Robotically Assisted UKA: A Multicenter Study. ISTA 2013. Big Island, HI.

40. Illgen RL, Bukowski BR, Abiola R. Outcomes after Primary Total Hip Arthroplasty: Manual Compared with Robotic Assisted Techniques.

41. Domb BG, El Bitar YF, Sadik BS, Stake CE, Botser IB. Comparison of Robotic-assisted and Conventional Acetabular Cup Placement in THA: A Matched-pair Controlled Study. Clin Orthop Relat Res. 2014 Jan;472(1):329-36.

42. Illgen R. Robotic Assisted THA: Reduce Outliers and Predictable Outcomes. 43rd Annual Course: Advances in Arthroplasty, October 22-25, 2013, Cambridge, MA.

43. Plate JF, Mofi di A, Mannava S, Smith BP, et al. Achieving Accurate Ligament Balancing Using Robotic-Assisted Unicompartmental Knee Arthroplasty. Advances in Orthopedics 2013(2013): 837167.

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The clinical and economic value of the Mako™ Robotic-Arm Assisted System

44. Zuiderbaan H, Ismael C, Khamaisy S, Thein R, Paul S, Pearle A. Unicompartmental Knee Arthroplasty versus Total Knee Arthroplasty: Are we able to create the forgotten joint? ICJR Pan Pacifi c, Hawaii, July 2014.

45. Esposito CI; Lipman J; Carroll KM; Jerabek SA; Mayman SA; Padgett DE. Acetabular Component Cup Placement Using a Haptically Guided Robotic Technology in Total Hip Arthroplasty. 16th EFORT Congress, May 28-30, 2015, Prague, Czech Republic.

46. Borus T, Robers D, Fairchild P, Christopher J, et al. UKA Patients Return to Function Earlier than TKA Patients. ISTA 27th Annual Congress, Sept. 24-27, 2014, Kyoto, Japan.

47. Maduekwe UI, Zywiel MG, Bonutti PM, Johnson AJ, Delanois RE, Mont MA. Scientifi c evidence for the use of modern unicompartmental knee arthroplasty. Expert Review of Medical Devices;7.2(March 2010): 219.

48. Aleto TJ, Berend ME, Ritter MA, Faris PM, Meneghini RM. Early Failure of Unicompartmental Knee Arthroplasty Leading to Revision. Arthroplasty 2008;23(2): 159-63.

49. Collier MB, Eickmann TH, Sukezaki F, McAuley JP, Engh GA. Patient, Implant, and Alignment Factors Associated with Revision of Medial Compartment Unicondylar Arthroplasty. J Arthroplasty 2006;21(6 Suppl 2): 108-15.

50. Blyth M, Smith J, Jones B, MacLean A, Anthony I, Rowe P. A CT based comparison of accuracy of unicompartmental knee arthroplasty (UKA) implant positioning with and without the aid of robotic surgical assistance.13th Annual CAOS Meeting, June 12-15, 2013, Orlando, FL, USA. (Blyth/Jones 2013a)

51. Coon T, Roche M, Buechel F, Borus T, Dounchis J, Conditt M, Pearle A. Short to Mid Term Survivorship of Robotic Arm Assisted UKA: A Multicenter Study. Pan Pacifi c Orthopaedic Congress. July 16-19, 2014. Kona, HI.

52. The Swedish Knee Arthroplasty Registry. Annual Report 2012. Department of Orthopaedics, Skåne University Hospital. Lund, Sweden.

53. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide:AOA; 2013.

54. Callanan, M.C et al. The John Charnlet award; risk factors for cup malpositioning quality improvement through a joint registry at a tertiary hospital. Clin Orthop Relt Res, 2011. 469(2): p. 319-29.

55. Lewinnek GE, Lewis JL, Tarr R, Compere CL, Zimmerman JR. Dislocations after total hip-replacement arthroplasties. J Bone Joint Surg Am. 1978;60(2):217–220.

56. Malik A, Maheshwari A, Dorr LD. Impingement with Total Hip Replacement. Journal of Bone and Joint Surgery 2007;89:1832-1842.

57. Elson L, Dounchis J, Illgen R, Marchand R, et al. A multi-centric evaluation of acetabular cut positioning in robotic-arm assisted total hip arthroplasty. 13th Annual CAOS Meeting, June 12-15, 2013, Orlando, FL, USA.

58. Suarez-Ahedo C, Gui C, Martin TJ, Stake CE, et al. Preservation of Acetabular Bone Stock in Total Hip Arthroplasty Using Conventional vs. Robotic Techniques, A Matched-Pair Controlled Study. World Arthroplasty Congress, April 15-18, 2015, Paris, France.

59. Pearle AD, Kendoff D, Stueber V, Musahl V, Repicci JA. Perioperative Management of Unicompartmental Knee Arthroplasty Using the MAKO Robotic Arm System (MAKOplasty). Am J Orthop. 2009;38(2 suppl):16-19.

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62. Xu B, Yang D, Aili R, Cao L. Effect of femoral offset change on pain and function after total hip arthroplasty. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2013 Jul;27(7):843-6.

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66. November 2013 Medical Product Safety Network (MedSun) Small Sample Survey – Final Report for the da Vinci Surgical System (PDF – 134KB). Available at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/ComputerAssistedSurgicalSystems/default.htm. Accessed November 2, 2015.

67. Jinnah R, Horowitz S, Lippincott C, Conditt M. Learning Curve of Robotically Assisted UKA. ISTA, Big Island, HI.

68. Redmond JM, Conditt MA, Gupta A, Hammarstedt JE, Petrakos AE, Gui C, Stake C, Domb BG. The Learning Curve Associated with Robotic-Assisted Total Hip Arthroplasty. ISTA 2014.

69. South County Hospital – Wakefi eld, RI. Stryker Orthopaedics Memo to File #4. October 15, 2015.

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72. Bozic, KJ, et al. The epidemiology of revision total hip arthroplasty in the United States. J Bone Joint Surg Am, 2009 91(1): p. 128-33.

73. Illgen R. Robotic Assisted Total Hip Arthroplasty Improves Accuracy and Clinical Outcome Compared with Manual Technique. Harvard Hip and Knee Course 2013.

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A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area. Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Mako, Stryker.

All other trademarks are trademarks of their respective owners or holders.

MKOEVS-AR-1 Copyright © 2015 Stryker.