CLINICAL OUTCOME FOLLOWING TLIF

• Professor,

Department of Neurosurgery,

Northwestern University,

Feinberg School of Medicine

•Interest: • MIS, Deformity, Intradural Tumors

Richard G. Fessler, MD, PhD

CLINICAL OUTCOME FOLLOWING TLIF

ONE AND TWO YEAR FOLLOW-UP OF

PROSPECTIVE DATA

Richard G. Fessler, MD, PhD

Professor

Northwestern University Feinberg School of Medicine

Chicago, IL

CONFLICT OF INTEREST

Medtronic

Consultant

Research funding

Royalty (Not related to MIS)

DePuy

Royalty (Not related to MIS)

Stryker

Consultant

ALIF

Intra-abdominal complications*

Vascular 11. 5 %

Neurological 17.9 %

Incisional 6.4 %

Urological 2.6 %

GI 6.4 %

Respiratory 7.7 %

Peritoneal 3.8 %

Spinal “event” 14.1 %

*Sasso et al, Spine, 2004

Posterior Lumbar Interbody Fusion (PLIF)

360 degree fusion

dorsal approach

anterior column support

minimizes the risk to intra-abdominal and retroperitoneal structures.

ADVANTAGES

Posterior Lumbar Interbody Fusion (PLIF)

Devitalization of the paraspinous musculature

Bilateral partial facetectomies -further destabilizing the spine

Pain

Nerve root / retraction injury

5 % average Cx rate in literature

DISADVANTAGES

Iatrogenic Muscle Injury

Kawaguchi Y. et. al. Spine, 1998; 23(21): 2282 -2288

Styf J.R. et. al. Spine, 1998; 23(3): 354-358

Weber B.R. et. al. Spine 1997; 22(15): 1765 - 1772

Kawaguchi Y. et. al. Spine, 1996; 21(22): 2683 - 2688

Kawaguchi Y. et. al. Spine, 1996; 21(8): 941 - 944

Kawaguchi Y. et. al. Spine, 1994; 19(22): 2590 - 2602

Rantanen J. et. al. Spine, 1993; 18(5): 568 - 574

Sihvonen T. et. al. Spine, 1993; 18(5): 575 - 581

Mayer T.G. et. al. Spine, 1989; 12(1): 33 - 36

Macnab I. et. al. Spine, 1977; 2(4): 294 - 298

Naylor A. JBJS, 1974; 56-B(1): 17 - 29

Jackson R.K. JBJS, 1971; 53-B(4): 609 - 616

Rationale: Microendoscopic TLIF

with Instrumentation

Adapt lumbar MED / MEDS

Avoid intra-abdominal surgery

Smaller skin incision

Decreased tissue trauma

Decreased muscle injury

Improved visualization

Improved post-operative course

? Improved long-term results

Surgical Technique

MAST-TLIF

Incision is determined fluoroscopically

Serial dilation of METRx

Facetectomy

Discectomy and Distraction

End Plate Preparation

Graft Insertion

Percutaneous Instrumentation

“Bulls-eye”

technique

Tapping

Screw Placement

Rod Placement

Percutaneous PLIF and Instrumentation

The Procedure

HAS IT IMPROVED OUTCOME?

PARASPINAL MUSCLE CHANGES ON MRI FOLLOWING POSTERIOR LUMBAR SURGERY

Muscle cross-sectional area (CSA) was measured and compared for the longissimus, illiocostalis and multifidus in the pre- and post-operative scan.

T 2 MRI, axial, 2mm cuts, no gap

Medical imaging processing and Visualization software from NIH

Lacey E. Bresnahan, PhD, R. David Fessler, BA, Richard

G. Fessler, MD., PhD ISSLS, May 1-4, 2009

OPEN

MEAN DECREASE 18 %

MED

MEAN INCREASE 2 %

Altered structure and function of spinal muscle fibers following posterior lumbar surgery

Muscle atrophy

Reduction in cross-sectional area

Increase fatty tissue

Reduction in muscle strength

Can lead to further post-op low back pain (LBP)

Clinical SignificanceMuscle Injury

Open

MIS

Long-Term Strength Assessment of Postoperative Spinal Surgery Patients

“…every strength parameter tested except male isokinetic flexion strength showed at least a 30% decrease when compared with normal values.”

Kahanovitz, Spine 1989 Apr; 14(4)

ResultsProspective

MAST TLIF vs OPEN PLIF

Demographics

0

10

20

30

40

50

Age

Open

Minimally-

Invasive

0

10

20

30

40

50

60

70

80

90

100

Male Female

Level of Surgery

100

0102030405060708090

L23 L34 L45 L5S1

Open

MAST

Operative Data

4.6

3.50

0

1

2

3

4

5

6

7

Operative Time (in hrs)

Open

Minimallyp=0.19 NS

Operative Data

0

200

400

600

800

1000

1200

Blood Loss

Open

Minimally-

Invasive

p<0.002

36

00

5

10

15

20

25

30

35

40

45

50

%Transfusion

p < 0.001

Hospital Data

0

20

40

60

80

100

120

140

160

180

200

Open

Minimally-

Invasive

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

5

Pain Rx (in MSO4 Eqvs.) Length of Stay (in days)

P<0.05P<0.10 NS

0

0.2

0.4

0.6

0.8

1

1.2

1 0.63 0.51 0.47 0.34

Preop 1wk 2-4wks 6wks 3-6mo

“Worst” Pain (% of Preop Value-VAS)

Narcotic Intake

0

20

40

60

80

100

120

140

Preop 1wk 2-4wks 6wks

On Long-term Narcotics Preop

0

2

4

6

8

10

12

14

16

Preop 1wk 2-4wks 6wks 3-6mo

(% of Preop Value)

Without Narcotics Preop

(MS04 Eqvs./day)

No CSF leaks

No infections

No medial breaches of the pedicle

No neurological injuries related to the procedure

No positioning-related complications

No hardware failures

Complications

1 CSF leak

No infections

No medial breaches of the pedicle

No neurological injuries related to the procedure

1 positioning-related complication

No hardware failures

Minimally-Invasive Open PLIF

1 YEAR RESULTSMAST TLIF PRE vs POST-OP

INDICATIONS

Degenerative disc disease-1 or 2 level

Grade I or II spondylolisthesis

Mechanical back pain

Radiculopathy

Instability (> 6 mm movement on F/E)

DESIGN

Prospective 62 patients

University of Chicago

All patients completed pre-operative and post-operative (1.5, 6, 12, 24) data forms VAS

Oswestry

SF-36

All data collected by research staff not otherwise involved with the study

Independent statistician (Paired t-test)

Follow-up: Data for 1 year

DESIGN AND DEMOGRAPHICS

0

10

20

30

40

50

60

AGE0

5

10

15

20

25

30

35

40

MEN WOMEN

Fusion rate: 100%

A/P, lat, F/E xrays

Bone growth

No motion

RESULTS

0

1

2

3

4

5

6

7

8

9

10

Pre-op Post--op

0

1

2

3

4

5

6

7

8

9

10

Pre-op Post-op

* p<.0001

VAS-BACK

*p<.002

VAS-Left leg

0

1

2

3

4

5

6

7

8

9

10

Pre-op Post-op

NS

VAS-Right leg

(paired t-statistic)

Visual Analog Score

0

1

2

3

4

5

6

7

8

9

10

Pre-op 6 wk 6 mo 1 yr 2 yr

BIAS analysis

RESULTS

0

10

20

30

40

50

60

Pre-Op Post-Op

Oswestry

*p < .0001

(Paired t-statistic)

RESULTS

0

10

20

30

40

50

60

70

80

90

100

Pre-op Post-op

NS

SF 36-GH

0

10

20

30

40

50

60

70

80

90

100

Pre-op Post-op

*p<.0001

SF 36-PF(Paired t-statistic)

SF-36Physical Functioning

0

10

20

30

40

50

60

Pre-op 6 wk 6 mo 1 yr 2 yr

OTHER VARIABLES

Sex

NS

VAS, Oswestry, SF-36

Age

NS

VAS, Oswestry, SF-36

LONG TERM RESULTSBACK PAIN

0

10

20

30

40

50

60

70

80

90

100

No Pain Better No Better

OPEN *

MAST

VAS * Dickman, Fessler, MacMillan, Haid,

J NSG 1992

LONG TERM RESULTSBACK PAIN

0

10

20

30

40

50

60

70

80

BETTER NO BETTER

Oswestry

-20

-10

0

10

20

30

40

50

60

BETTER NO BETTER

SF-36

%

Change

From

Pre-op

%

Change

From

Pre-op

COMPLICATIONS

2 CSF leaks

1 local wound infection

1 DVT (acute on chronic)*

2 graft retropulsions

One year follow upTwo prospectively followed cohorts

Non-randomized

Two institutions

PLIF Saint John, NB, Canada

mTLIF Chicago, IL, USA

Patients requiring lumbar interbody fusions

All patients followed using VAS pain scores and Oswestry Disability Index

Radiographic determination of fusion

ResultsTLIF

29 patients

19 female

Mean age = 54 ± 14*

Previous surgery (5)

Disc same level – 2

Laminectomy same level - 3

PLIF

31 patients

14 female (n.s.)

Mean age = 42 ± 11

Previous surgery (4)

Disc same level – 2

Adjacent anterior fusion – 1

Distant posterior fusion - 1

* p < 0.05

Open

CSF leak – 2

Ileus – 3

Footdrop – 2

Infection – 1

MAST

CSF leak – 3

Migration of interbody graft – 2

Both cases Boomerang

DVT – 1

Results

Complications

Results

0

10

20

30

40

50

60

70

80

90

100

Open MAST

Pseudarthroses

Fusions

96.6%83.9%

p = 0.068

Results

Mean Estimated Blood Loss

0

200

400

600

800

1000

1200

c.c

.'s Open

MAST

p < 0.0001

Results

Mean Hospital Stay

0

20

40

60

80

100

120

140

160

180

Ho

urs Open

MAST

p < 0.027

Clinical Outcomes

0

10

20

30

40

50

60

70

80

90

100

VAS Back VAS Leg Oswestry

PreOp TLIF 1 yr TLIF PreOp PLIF 1 yr PLIF

p=0.001p=0.009

p=0.002

p<0.001p<0.001

p<0.001

p = 0.9p = 0.9 p = 0.4

p = 0.0001p < 0.0001

p < 0.0001

THANK YOU

OBESITY:OUTCOME FOLLOWING MINIMALLY INVASIVE FUSION SURGERY

Rosen, D., Ferguson, S., Ogden, A.T., Huo, D., Fessler, R.G.: Obesity and

Self Reported Outcome after Minimally Invasive Lumbar Spinal Fusion

Surgery. Neurosurgery 63:956-960, 2008.

DEMOGRAPHICS

Age 56.4 (19-85)

Height 169 cm

Weight 82.2 kg

BMI 28.7 kg/m2

TOTAL 110 patients

WEIGHT DISTRIBUTION

< 25 NORMAL

25-30 OVERWEIGHT

> 30 OBESE

> 30

25-30

< 25

RESULTS

VAS = NS DIFFERENCE between groups

ODI = NS DIFFERENCE between groups

SF-36 = NS DIFFERENCE between groups

Linear Regression Analysis = No correlation between BMI and any outcome measure

OPERATIVE TIME

0

1

2

3

4

5

6

7

8

9

10

< 25 25-30 > 30

HOURS

BMINo significant difference

ESTIMATED BLOOD LOSS

0

2

4

6

8

10

12

14

16

18

< 25 25-30 > 30

< 100 cc

100-250 cc

> 250 cc

No significant difference

MAJOR COMPLICATIONS

1 Positioning injury (?)

= 0.8 %

(This occurred in the “normal” group)

MINOR COMPLICATIONS

OVERALL 22 %

< 25

25-30

> 30

BMI < 25 BMI 25-30 BMI > 30

Post-op radiculopathy

3 2

Lower extremity weakness

1

Urinary retention 2

Durotomy 1 1

Superficial wound infection

1

Delirium 3 2

Nausea 1

CHF exacerbation

1

Hypertension 1 1

Hypotension 1 1

Ileus 1

PERCENT OF TOTAL 23 26 14

COMPARISON

OPEN MISS

Increased complication rate YES NO

Increased wound infection rate

YES NO

Increased operative time YES NO

Increased blood loss YES NO

Length of stay NO NO

Outcome after fusion NO NO

Patient satisfaction YES NO

John E. O‟Toole, MD, Griffin Meyers, BA, and Richard G. Fessler, MD, PhD Reduction in Spinal

Surgical Site Infection Rates After Minimally Invasive Surgery

Journal of Neursurgery: Spine, 11: 471-476, 2009.

Reported infection rate in open surgery 0.9 to 15 %.

1338 MIS procedures

12 mo follow up

0.2 % overall infection rate

0.7 % for MEDS and TLIF

0.1 % for all others

CONCLUSIONS

MIS is equivalent to or superior to open surgery for:

Neurologic result

Pain relief

Fusion rate

For virtually every operation developed and tested to date.

CONCLUSIONS MIS achieves these results with

Less EBL

Less stress response

Less pain meds

Less ICU stay

Less hospital stay

Faster D/C

Faster recovery

Faster return to work

Lower complication rate

Lower infection rate

And can more safely be used in high risk patients

ACKNOWLEDGEMENTS

FELLOWS Larry Khoo University of California, Los Angeles (2000-2001)

Mick Perez Detroit (2001-2002)

Rob Isaacs Duke University (2001-2002)

Faheem Sandhu Dallas, TX (2002-2003)

Paul Santiago Washington University, St. Louis, MO (2002-2003)

Bong Soo Kim Neurosurgery resident-Temple (2003-2004)

Trent Tredway University of Washington (2003-2004)

John Song Northwestern University (2004-2005)

Sean Christie QE II Health Science Center (2004-2005)

John O’Toole Rush University Medical School (2005-2006)

Kurt Eichholz Vanderbilt University (2005-2006)

Vishal Gala Georgia Spine Institute (2006-2007)

Jean-Marc Voyadzis George Washington University (2006-2007)

Justin Smith Univeristy of Virginia (2007-2008)

Fred Ogden Columbia University (2007-2008)

Jim Thoman Indianapolis Neurosurgical (2008-2009)

Sathish Subbaiah Mount Sinai (2008-2009)

STUDENTS Melody Hrubes University of Illinois-Chicago

Lacey Bresnahan, ME University of Illinois-Chicago

THANK YOU

THERE IS NO LONGER ANY QUESTION

MINIMALLY INVASIVE TLIF PROVIDES

SIGNIFICANT ADVANTAGES

Conclusions

The MAST-TLIF technique provides an

option for percutaneous interbody fusion.

This technique is safe, diminishes

intraoperative blood loss, postoperative

pain, total narcotic use, and the risk of

transfusion.

One year results demonstrate statistically

significant decreases in VAS, increases in

Oswestry, and improvement in SF-36

physical functioning.

A minimally-invasive TLIF can be

performed without a significant increase

in surgically-related complications.

OPEN vs Minimal Access Spine Surgery

0

20

40

60

80

100

1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001

MISS

OPEN

Curtis Dickman Barrow Neurological Institute (1990-1991)

Bruce McCormick University of California, San Francisco (1991-1992)

Daniel May University of Zurich (1992-1993)

Emily Friedman Oklahoma Neurosurgical (1992)

John Marshak Hudson Orthopedics, Georgia (1992-1993)

Michael Sturgill Private Practice-Racine, Wisconsin (1993-1994)

Srinath Samadrala University Southern California (1995-1996)

Ehud Mendel MD Anderson Cancer Center (1996-1997)

Ben Guiot University of South Florida (1997-1998)

Daniel Kim Stanford University (1997-1998)

Sim Brara Kaiser Permanente Los Angeles, California (1998-1999)

Paul Boone Vanderbilt University (1998-1999)

Anthony Frempong-Boadu New York University (1999-2000)

Larry Khoo University of California, Los Angeles (2000-2001)

Dan Laich Denver Neurosurgical (2000-2001)

Mick Perez Rush Medical School (2001-2002)

Rob Isaacs Cleveland Clinic, Fort Lauderdale (2001-2002)

Faheem Sandhu Private Practice-Dallas, TX (2002-2003)

Paul Santiago Washington University, St. Louis, MO (2002-2003)

Bong Soo Kim Neurosurgery resident-Temple (2003-2004)

Trent Tredway University of Washington (2003-2004)

John Song Current fellow (2004-2005)

Sean Christie Current fellow (2004-2005)

FELLOWS

2-level TLIFs

Two level TLIF/Sextant

SPONDYLOLISTHESIS

0

5

10

15

20

25

Nl Align Spondy

Minimally-Invasive Interbody Fusion – Cadaveric Study

3 cadaveric torsos

6 motion segments fused – interbody grafting followed by percutaneous pedicle screws

Intervertebral height, foraminal height and volume increased

No significant pedicle violations

Could be safely and efficaciously implemented for clinical use

Neurosurgery November supplement, 2002

Study # 1Methods

Prospective

125 consecutive patients

May ‟01 to September „03

First study: 1 yr f/u of 75 pts with matched open controls

Grade 1 – 2 spondylolisthesis or pure mechanical back pain

Symptoms radiculopathy and back pain w/ collapsed disc

Failed extensive conservative management

Methods

Operations all performed with one senior surgeon (R.F.)

Control group: 20 open, single-level PLIF at the same institutions over the same time period

Rush Medical Center, Chicago, IL

Columbus Hospital, Chicago, IL

Ravenswood Hospital, Chicago, IL

Sextant™ Instrumentation with TLIF

1 month Post OP

3 MONTHS

IF YOU DON‟T DO MINIMAL ACCESS SPINE SURGERY…

ITS TIME TO LEARN!

BOTTOM LINE

IF YOU DON‟T WANT TO LEARN…

BE A “BRAIN” SURGEON!!!

Case – Spondylolisthesis

Case - Spondylolisthesis

Case – Mechanical LBP s/p failed discectomy

Graft Placement / PLF

Conclusions

The METLIF technique provides an

option for percutaneous interbody fusion.

This technique is safe, diminishes

intraoperative blood loss, postoperative

pain, total narcotic use, and the risk of

transfusion.

Initial data suggests early postoperative

pain reduction.

A minimally-invasive TLIF can be

performed without a significant increase

in surgically-related complications.

CONCLUSIONS

The results appear to be long lasting

FEA/biomechanical data suggests biomechanically that the results will be superior to open surgery in the long term