Bhr Messaging Brochure

7/27/2019 Bhr Messaging Brochure

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What does your hip patient want to get back to?Hip pain limited Tim Taylor’s performance. After choosing the BHR system, he is back to enjoying activities pain free.

Tim Taylor, former professionalhockey player, post BHR™ surgery



Why BHR™?

What does your hip patient want to get back to?

The BIRMINGHAM HIP™ Resurfacing (BHR) System was designed to provideyounger or more active patients with a bone-preserving, anatomically correctalternative to total hip arthroplasty that may support an active lifestyle.

After his BHR procedure, former pro

quarterback Steve Beuerlein returnedto coaching his son’s football team. Astudy shows improved function andfaster recovery in BHR system patientscompared to patients with THA.1



Where do you want your hip patient to be in 15 years?A wear resistant metal-on-metal articulation, large diameter bearing and bone preserving procedureprovides durability, stability and preservation of normal anatomy that may improve the patient’slong-term results.

THA has great results – For younger or active patients, BHR™ results are even betterThe Australian National Joint Registry2 shows a higher recorded survivorship rate in both the male<55 years of age and male 55-64 years of age groups for primary hip resurfacing procedures compared

to primary conventional hip procedures (primary diagnosis OA excluding infection). The BHR systemwas designed as an alternative for these younger or more active patients where, historically, total hipreplacements have not performed as well.

With a total hip replacement,a large amount of bone is removed

With the BHR system, the outer layerof the femoral head is removed

The BHR system keeps more of theoriginal bone allowing patients toregain their active lifestyle

Resurfacing vs THA male <55Resurfacing vs THA male 55-64

Years

0

0.5

1

1.5

2

2.5

3

1 2 3 4 5

R e v i s i o n r a t e %

SRA

THA

6 7

3.5

4

4.5

Years

0

0.5

1

1.5

2

2.5

3

1 2 3 4 5

R e v i s i o n r a t e %

SRA

THA

6 7

3.5

4

4.5



Bone preservationBone preservation is a central concernfor younger patients who want to returnto an active lifestyle. By preservingthe function of existing bone rather than removing and replacing a largesection of the femur , natural anatomicalbiomechanics can be maintained.

Improved bone strengthThe BHR™ system preserves a large portion of thenatural femoral neck and head. Studies showa significant increase in proximal femoral bone mineral density (BMD) in BHR patients

compared to THA patients at two years.These studies conclude that the BHR devicebetter transfers physiological load for preservingbone stock than a long-stemmed device.3,4

Post-operative stabilityThe larger diameter bearing and bonepreserving procedure of the BHR system mayrestore patients’ normal anatomy. This, inturn, can reduce the risk of dislocation.

Revision SurgeryWhich would you rather revise after 10 years,BHR (Figure 1) or THA (Figure 2)? Total hipreplacement patients can experience proximalfemoral bone resorption and distal remodeling,as shown here. The BHR system preservesthis bone, which therefore may be in conditionto receive a primary stem at the time a totalhip could require a complex revision.

Figure 1: BHR at 10 years

Figure 2: Tapered proximal loading THA at 10+ years



The BHR system is the world leader of hip resurfacingThe 2008 Australian Joint Replacement Registry Annual Report2 contains data from September1999 to December 2007 and is among the most compliant registries globally.

• With 7,682 implantations, the BHR device accounts for 72% of all resurfacing devices implantedto date in the registry.

• The BHR device has follow up from the inception of the registry in 1999 and consistently showsthe lowest recorded revision rate of any resurfacing device for seven years.

Globally proven clinical resultsThe BIRMINGHAM HIP™ Resurfacing (BHR™) System hasdemonstrated exceptional clinical results worldwide.

Published articles from around the world demonstrate unrivaled

performance of the BHR device in many surgical centers.

Australian National Joint Registry Annual Report 2008 – Yearly cumulative percentage revision of resurfacing hip systems

Author Site N % survival Follow-up

McMinn et al3 Birmingham 1,626 98.4 5 years

Shimmin et al4 Melbourne 230 99.1 5 years

Treacy et al5 Birmingham 144 98.0 5 years

Nishii et al6 Osaka 50 96.0 5 years

Steffen et al7 Oxford 79 95.1 7 years

Oswestry Registry8 8 countries – 45 surgeons 1,354 97.2 7 years

Cumulative percent revised

Resurfacing product 1 year 2 years 3 years 5 years 7 years

ASRTM 3.8 5.3 6.0

AdeptTM 0.5 4.8

BHR 1.5 2.1 2.5 3.6 4.6

ConserveTM Plus 3.2 3.2 6.0 10.1

Cormet® 2.1 3.3 4.5 6.5

Cormet 2000 (HAP) 6.3 7.4 8.4 10.3

Durom® 3.5 4.7 5.8

MitchTM TRH 1.7

Recap® 5.7 5.7 5.7



Metallurgy matters at startupThe BHR™ implant is produced usinghigh carbon cobalt chrome left inthe As Cast (never heat treated) micro-structural condition. As Castcomponents show substantially lesswear than heat-treated components.11

Double heat-treated CoCr implantA magnified cross section of a double heat-treated CoCr implashows block carbides depleted in both quality and quantitThermal processes – including hot isostatic pressing, solutionheat treatment and sintering – alter the microstructuredirectly affecting the wear resistance of the material.12, 13, 14

Wear studies have shown that cobaltchrome in the As Cast form hassuperior wear resistance comparedto other forms of the alloy.15 ,16, 17

Clinical data examining a single surgeonseries of resurfacing cases has showna decrease in long-term survivorshipwith a double heat-treated implantversus a single heat-treated implant with identical implant geometry.18,

As Cast CoCr BHR implantsMagnified cross sections show block carbides* integratedthroughout the metal structure.These carbides are harder

than the metal substrate and reduce wear , especiallyat startup.

As Cast CoCr Ring implantA magnified cross section retrieved after 26 years in-vivo shows block carbides integrated throughout the metal structuBHR metallurgy is based on this successful clinical heritag

100

90

80

70

60

50

0 2 4 6 8 10Follow-up in Years

S u r v i v a l p r o b a b i l i t y ( % )

10 year Kaplan-Meier Survival Analysisof CORIN Hip Resurfacings(Revision for any reason as the end-point)

86%

96%

Single heat treated (n=107)

Double heat treated (n=184)



Clearance matters in motionThe BHR™ system is designed to a precisegeometry based on clinically successfulfirst generation metal-on-metal total hips,which provides fluid lubrication in thebearing reducing long-term wear.19

Superior fixationThe BHR implant has a hemispherical cup designwith the cast-in POROCAST™ ingrowth surface.This HA coated ingrowth surface does not requireany heat treatment to attach beads and thereforepreserves the carbide structure. This surface isintegral to the cup and not a spray on coating.

POROCAST ingrowth surface

Friction vs clearance in pre- and post- distorted cups for metal-on-metal bearings

Providing fluid lubricationThe longevity of a metal-on-metal bearing islinked to its ability to generate and sustain a fluidfilm. At rest, static pressure can force fluid outof the bearing. In motion, hydrodynamic forcescreate a fluid film that lubricates the joint.

There is an optimal radial clearance* associatedwith each bearing diameter. When this clearanceis produced, the converging wedge between thehead and cup draws in and transports lubricatingfluids between the components extremely well.

In comparison, studies show that smaller clearances result in increased friction.20, 21 Increased friction can lead to frictional torque forcebetween the head and cup that can cause cup

micromotion which may hamper bone ingrowth.22

Smaller clearances may not allow sufficientlubrication which may increase long-term wear .23

In hip arthroplasty, impaction of the cup canresult in cup deflection. Ultra-low clearancebearings can suffer from a “clamping” effect if the combination of deflection and low clearancedoes not allow for actual net clearance.

fluid film



References

Haddad FS, Bull J, Soler JA. Hip resurfacing has superior sustained functional outcomes when compared toTotal Hip Arthroplasty. Presented at: AAOS. March 6-8, 2008; San Francisco, CA.

Australian Orthopaedic Association National Joint Replacement Registry Annual Report 2008.

Kishida Y, Sugano N, Nishii T, Miki H, Yamaguchi K, Yoshikawa H. Preservation of bone mineral density of the femur aftersurface replacement of the hip. The Journal of Bone and Joint Surgery (Br) (March 2004), 86-B 185-89.

Hayaishi Y, Miki H, Nishii T, Hananouchi T, Yoshikawa H, Sugano N. Proximal femoral bone mineral density after resurfacing total hip arthroplasty and after standardstem-type cementless total hip ar throplasty, both having similar neck preservation and the same articulation type. J Arthroplasty. 2007 Dec; 22(8):1208–1213.

FDA Review Memo, BHR Impor tant Medical Information, Page 59.

Back DL, Dalziel R, Young D, Shimmin A. Early results of primary BIRMINGHAM HIP resurfacings - An independentprospective study of the first 230 hips. J Bone Joint Surg Br, 2005, 87(3):324-9.

Treacy RB, McBryde CW, Pynsent PB. BIRMINGHAM HIP resurfacing arthroplasty. A minimum follow-up of five years. J Bone Joint Surg Br (2005 Feb) 87(2):167-70.

Nishii T, Sugano N, et al. Five-year results of metal-on-metal resurfacing arthroplasty in Asian patients. JOA (2007) Vol. 22 No. 2.

Steffen RT, Pandit HP, Palan J, Beard DJ, Gundle R, McLardy-Smith P, Murray DW, Gill HS. The five-year results of theBIRMINGHAM HIP arthroplasty – An independent series. J Bone Joint Surg Br (2008 Apr); 90-B:436-41.

0. Richardson JB, et al. Minimum 7-year outcome of the BIRMINGHAM HIP Resurfacing. A review of 1,345 cases fromthe 2007 international register. Presented at the 2007 British Or thopaedic Association.

. Nelson K, Dyson J. Wear simulation of a metal-on-metal resurfacing prosthesis. AEA Technology Group, Harwell, UK. 1997.

2. Que L. Effect of heat treatment on the microstructure, hardness and wear resistance of the as-cast and forged cobalt-chromium implantalloys. Presented at the Symposium on cobalt-based alloys for biomedical application. Nov 3-4, 1998, Norfolk, Virginia, USA.

3. Varano R, Bobyn JD, Medley JB, Yue S. Does alloy heat treatment influence metal-on-metal wear? Poster #1399 presentedat the 49th Annual meeting of the Orthopaedic Research Society. New Orleans, LA, USA. 2003.

4. Cawley J, Metcalf JEP, Jones AH, Band TJ, Skupien A. A tribological study of cobalt chromium molybdenum alloysused in metal-on-metal resurfacing hip arthroplasty. Wear, 255 (2003) pp. 999-1006.

5. Ahier S, Ginsburg K. Influence of carbide distribution on the wear and friction of Vitall ium. Poc Inst Mech Eng, 1966; 181:127-9.

6. Clemow AJT, Daniell BL. The influence of microstructure on the adhesive wear resistance of a Co-Cr-Mo alloy.Wear, 1980; 61:219-31.

7. Wang KK, Wang A, Gustavson LJ. Metal-on-metal wear testing of chrome cobalt alloys. In: Digesi JA, Kennedy RL, Pillar, eds. Cobalt-

based alloys for bio-medical applications, ASTM STP 1365: Wear Characterization. West Conshohocken, PA 1999; 135-44.

8. McMinn DJW. Ten year Kaplan-Meier survival analysis of McMinn Corin hip resurfacings.Journal Of Engineering In Medicine, 2005, Proceedings Institute of Mech Engineers, Part H.

9. McMinn D. Development of metal/metal hip resurfacing. Hip International. 2003; 13(1) suppl 2.

0. McMinn DJW, et al. Friction testing in metal-on-metal bearings with dif ferent clearances using blood as lubricant.52nd Annual Meeting of the Orthopaedic Research Society, 2006. Paper No. 0500.

. Kamali A, Daniel JT, Javid SF, Youseffi M, Band T, Ashton R, Hussain A, Li CX, Daniel J, McMinn DJW. The effect of cup deflection on friction in metal-on-metal bearings, AAOS, 5-8 March 2008, Poster Exhibit.

2. McMinn DJW. BHR lecture, BOA Manchester 2004.

3. Unsworth A, Vassiliou K, Elfick APD, Scholes SC. The effect of “running-in” on the tribology and surfacemorphology of metal-on-metal hip resurfacing devices in simulator studies. JEIM Par t H 2.

Orthopaedic Reconstruction & TraumaSmith & Nephew, Inc.1450 Brooks RoadMemphis, TN 38116USA

Telephone: 1-901-396-2121Information: 1-800-821-5700Orders and Inquiries: 1-800-238-7538

www.smith-nephew.comwww.HipResurfacing.com

™Trademark of Smith & Nephew.Certain marks Reg. US Pat. & TM Off.

©2008 Smith & Nephew, Inc.All rights reserved.

7138-1477 45670511 10/08

block carbides: microscopic, ceramic-like particles that form during the casting of high carbon cobalt chrome.They become an integral part of the cast metal microstructure and are harder (more wear resistant) than the metal substrate.

radial clearance: the space defined by the difference between the radius of the femoral head and the radius of the cup.This clearance provides a space in the bearing in which viscous fluids can lubricate the movement of the head within the cup.

Bhr Messaging Brochure

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