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Norwegian Manual Therapy Oslo March 2012 Adriaan Louw, PT, PhD (c), M.App.Sc (physio) 1 The Efficacy of Lumbar Surgery Adriaan Louw, PT, PhD (c), M.App.Sc (physio), CSMT Spinal Surgery in the US The likelihood of having spinal surgery in the US is 5 times higher than that of the United Kingdom, and at least twice than the surgery rates of Australia, Canada and Scandinavian countries. 2 Cherkin DC, Deyo RA, Loeser JD, Bush T, Waddell G. An international comparison of back surgery rates. Spine. Jun 1 1994;19(11):1201- 1206.

The Efficacy of Lumbar Surgery - manuellterapi.net fileThe Efficacy of Lumbar Surgery Adriaan Louw, PT, PhD (c), M.App.Sc (physio), CSMT Spinal Surgery in the US •The likelihood

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Norwegian Manual Therapy Oslo March 2012

Adriaan Louw, PT, PhD (c), M.App.Sc

(physio) 1

The Efficacy of Lumbar

Surgery

Adriaan Louw, PT, PhD (c), M.App.Sc (physio), CSMT

Spinal Surgery in the US

• The likelihood of having spinal surgery in the US is 5 times higher than that of the United Kingdom, and at least twice than the surgery rates of Australia, Canada and Scandinavian countries.

2

Cherkin DC, Deyo RA, Loeser JD,

Bush T, Waddell G. An international

comparison of back surgery rates.

Spine. Jun 1 1994;19(11):1201-

1206.

Norwegian Manual Therapy Oslo March 2012

Adriaan Louw, PT, PhD (c), M.App.Sc

(physio) 2

Increased Lumbar Fusions

• Between 1996 – 2001 – Spinal fusions rose by 77%

– Total hip arthroplasty (THA) and total knee arthroplasty (TKA) rose by 13%

4

Deyo RA, Mirza SK. Trends

and variations in the use of

spine surgery. Clin Orthop

Relat Res. Feb

2006;443:139-146.

Norwegian Manual Therapy Oslo March 2012

Adriaan Louw, PT, PhD (c), M.App.Sc

(physio) 3

Increase in Spinal Surgery • Patients with DDD:

– Between 1990 – 1993: 9.4% underwent spinal fusion

– Between 1997 – 2000: 19.1% underwent spinal fusion (> 200% increase)

• In addition to a rising rate of lumbar fusion surgery, it seems an increasing proportion of all spine operations include a fusion procedure: – For spinal stenosis, spine fusions quadrupled.

Deyo RA, Mirza SK. Trends and variations in the use

of spine surgery. Clin Orthop Relat Res. Feb

2006;443:139-146.

Cage Updates: • Fusions with cages

increased from

3.6% in 1996 to

58.1% in 2001.

(1500% increase)

6

Deyo RA, Mirza SK. Trends and variations in the use

of spine surgery. Clin Orthop Relat Res. Feb

2006;443:139-146.

Norwegian Manual Therapy Oslo March 2012

Adriaan Louw, PT, PhD (c), M.App.Sc

(physio) 4

Outpatient Ambulatory Surgery

• Discectomies performed on outpatients rose from

4% in 1994 to 26% in 2000

• 650% increase

Gray DT, Deyo RA, Kreuter W, et al. Population-based trends in

volumes and rates of ambulatory lumbar spine surgery. Spine.

Aug 1 2006;31(17):1957-1963; discussion 1964.

Before we examine outcomes of surgery…

• Spine surgery patients only care about:

– Loss of Pain

– Improved Function – No complications

1. Louw, A., Q. Louw, et al. (2009). "Preoperative Education for Lumbar Surgery for

Radiculopathy." South African Journal of Physiotherapy 65(2): 3-8.

2. Lurie, J. D., S. H. Berven, et al. (2008). "Patient preferences and expectations for care:

determinants in patients with lumbar intervertebral disc herniation." Spine 33(24):

2663-2668.

3. Toyone, T., T. Tanaka, et al. (2005). "Patients' expectations and satisfaction in lumbar

spine surgery." Spine 30(23): 2689-2694.

4. Yee, A., N. Adjei, et al. (2008). "Do patient expectations of spinal surgery relate to

functional outcome?" Clin Orthop Relat Res 466(5): 1154-1161.

Norwegian Manual Therapy Oslo March 2012

Adriaan Louw, PT, PhD (c), M.App.Sc

(physio) 5

Patient’s don’t give a $%#^ about fusion

rates • To compare the outcomes of the 3 fusion methods and

find a useful fusion method.

• Complications included deep infection in 3 cases, transient nerve palsy in 4, permanent nerve palsy in 1, and donor site pain in 6.

• No significant differences in clinical results and union rates were found among the 3 fusion methods.

Kim KT, Lee SH, Lee YH, Bae SC, Suk KS. Clinical

outcomes of 3 fusion methods through the posterior

approach in the lumbar spine. Spine. May 20

2006;31(12):1351-1357; discussion 1358.

Patient’s don’t give a $%#^ about

migration (unless it’s birds) 1. Aoki, Y., M. Yamagata, et al. (2010). "Examining risk factors for

posterior migration of fusion cages following transforaminal lumbar

interbody fusion: a possible limitation of unilateral pedicle screw

fixation." Journal of neurosurgery. Spine 13(3): 381-387.

2. Aoki, Y., M. Yamagata, et al. (2009). "Posterior migration of fusion

cages in degenerative lumbar disease treated with transforaminal

lumbar interbody fusion: a report of three patients." Spine 34(1):

E54-58.

3. Chen, L., H. Yang, et al. (2005). "Cage migration in spondylolisthesis

treated with posterior lumbar interbody fusion using BAK cages."

Spine 30(19): 2171-2175.

4. Smith, A. J., M. Arginteanu, et al. (2010). "Increased incidence of

cage migration and nonunion in instrumented transforaminal lumbar

interbody fusion with bioabsorbable cages." Journal of neurosurgery.

Spine 13(3): 388-393.

Norwegian Manual Therapy Oslo March 2012

Adriaan Louw, PT, PhD (c), M.App.Sc

(physio) 6

Long-term outcome of surgical and non-surgical

treatment of LSS: 8-10 year outcomes:

• After 8 to 10 years:

– LBP improved: 53% surgery vs. 50% nonsurgical

– Predominant symptom (either back or leg pain) improved: 54% surgery vs. 42% nonsurgical

– Satisfied with their current status: 55% surgical vs. 49% nonsurgical

• By 10 years:

– 23% of surgical patients: Undergone another surgery

– 39% of nonsurgical patients: Undergone surgery

Atlas SJ, Keller RB, Wu YA, Deyo RA, Singer DE. Long-term outcomes of surgical and

nonsurgical management of lumbar spinal stenosis: 8 to 10 year results from the maine

lumbar spine study. Spine (Phila Pa 1976). Apr 15 2005;30(8):936-943.

Laminectomy/Laminotomy

• Forty-five patients (84.9%) were satisfied with the treatment result after a follow-up period of 15.7 months (12-24).

• ODI improved from 64.3 to 16.7.

• There were 11 surgical complications: dural tear in 5, wrong level operation in 2, and transient neuralgia in 4 patients.

Pao, J. L., W. C. Chen, et al. (2009). "Clinical outcomes of microendoscopic

decompressive laminotomy for degenerative lumbar spinal stenosis." Eur Spine J

18(5): 672-678.

Norwegian Manual Therapy Oslo March 2012

Adriaan Louw, PT, PhD (c), M.App.Sc

(physio) 7

Laminectomy/Laminotomy

• Treatment effects (defined as mean change in surgery group minus mean change in non-operative group) for:

– Bodily pain 12.6

– Physical function 8.6

– Oswestry Disability index -9.4

• Early advantages for surgical treatment for secondary measures such as bothersomeness, satisfaction with symptoms, and self-rated progress were also maintained.

Weinstein, J. N., T. D. Tosteson, et al. (2010). "Surgical versus nonoperative treatment

for lumbar spinal stenosis four-year results of the Spine Patient Outcomes Research

Trial." Spine (Phila Pa 1976) 35(14): 1329-1338.

Weinstein, J. N., T. D. Tosteson, et al. (2010)

Norwegian Manual Therapy Oslo March 2012

Adriaan Louw, PT, PhD (c), M.App.Sc

(physio) 8

Laminotomy • In group A, at the final

evaluation, the overall results were good to excellent in 89% of the patients, fair 11%, and poor 0%.

• In group B, at the final evaluation, the overall results were good to excellent in 63% of the patients, fair 30%, and poor 7%.

Fu, Y. S., B. F. Zeng, et al. (2008). "Long-term

outcomes of two different decompressive techniques

for lumbar spinal stenosis." Spine (Phila Pa 1976)

33(5): 514-518.

Laminotomy

• 5.6 years post-op follow-up

– 85.3% had an excellent-to-fair operative result.

– Reoperation rate of 11.8%.

Oertel MF, Ryang YM, Korinth MC, Gilsbach JM, Rohde V. Long-term results of

microsurgical treatment of lumbar spinal stenosis by unilateral laminotomy for bilateral

decompression. Neurosurgery. Dec 2006;59(6):1264-1269; discussion 1269-1270.

Norwegian Manual Therapy Oslo March 2012

Adriaan Louw, PT, PhD (c), M.App.Sc

(physio) 9

Summary: Laminectomy/Laminotomy • Success rate ~ 80%

• Effective for leg symptoms – pain, neurological, etc.

• Most research – spinal stenosis

• Long-term slightly better than conservative care

• Indicated in neurological deficit

Discectomy – very well studied

• The reported success rate of

lumbar disc surgery varies from

60% to 90% (Ave 80%)

1. Korres DS, Loupassis G, Stamos K. Results of lumbar discectomy: a study using 15

different evaluation methods. European Spine Journal 1992;1:20–4

2. Findlay GF, Hall BI, Musa BS, Oliveria MD, Fear SC. A 10-year follow-up of the

outcome of lumbar microdiscectomy. Spine 1998; 23:1168–71

3. Loupasis GA, Stamos K, Katonis PG, Sapkas G, Korres DS,Hartofilakidis G. Seven-

to 20-year outcome of lumbar discectomy. Spine 1999;24:2313–7.

4. Yorimitsu E, Chiba K, Toyama Y, et al.Long term outcomes of standard discectomy

for Lumbar Disc Herniation. Spine 2001;26:652– 8.

Norwegian Manual Therapy Oslo March 2012

Adriaan Louw, PT, PhD (c), M.App.Sc

(physio) 10

Discectomy in Athletes

• NBA

– Discectomy: 75% returned to play again in the NBA

– Non-surgical: 88% returned to the NBA • Anakwenze OA, Namdari S, Auerbach JD, et al. Athletic performance

outcomes following lumbar discectomy in professional basketball players. Spine (Phila Pa 1976). Apr 1, 2010 2010;35(7):825-828.

• NFL – Discectomy: 78% returned to NFL

• Hsu WK. Performance-based outcomes following lumbar discectomy in professional athletes in the National Football League. Spine (Phila Pa 1976). May 20 2010;35(12):1247-1251.

Microdiscectomy • Have not yet shown any advantage over traditional

discectomy – Porchet F, Bartanusz V, Kleinstueck FS, et al. Microdiscectomy compared with

standard discectomy: an old problem revisited with new outcome measures within the framework of a spine surgical registry. Eur Spine J. Aug 2009;18 Suppl 3:360-366.

– Veresciagina K, Spakauskas B, Ambrozaitis KV. Clinical outcomes of patients with lumbar disc herniation, selected for one-level open-discectomy and microdiscectomy. Eur Spine J. Sep 2010;19(9):1450-1458.

– Teli M, Lovi A, Brayda-Bruno M, et al. Higher risk of dural tears and recurrent herniation with lumbar micro-endoscopic discectomy. Eur Spine J. Mar 2010;19(3):443-450.

• Microdiscectomy gives broadly comparable results to open discectomy. – Gibson JN, Waddell G. Surgical interventions for lumbar disc prolapse. Cochrane

Database Syst Rev. 2007(2):CD001350.

Norwegian Manual Therapy Oslo March 2012

Adriaan Louw, PT, PhD (c), M.App.Sc

(physio) 11

Discectomy – Summary

• 80% success rate

• Predominantly for leg pain

due to HNP

• No difference between

open vs. microdiscectomy

Fusions

• No conclusions are possible

about the relative effectiveness

of anterior, posterior, or

circumferential fusion.

Gibson JN, Waddell G. Surgery for degenerative

lumbar spondylosis: updated Cochrane Review.

Spine. Oct 15 2005;30(20):2312-2320.

Norwegian Manual Therapy Oslo March 2012

Adriaan Louw, PT, PhD (c), M.App.Sc

(physio) 12

Spinal Fusion – At least 10 patients (22%) required revision surgery.

– Ten patients (22%) had 14 total complications not requiring

revision surgery.

– Seventy percent of patients had a fair or poor outcome

– 58% of patients had at least "severe disability" according to

the Oswestry outcome scale.

– Fifty percent of patients were satisfied with their surgery

Button G, Gupta M, Barrett C, Cammack P, Benson D. Three- to six-

year follow-up of stand-alone BAK cages implanted by a single surgeon.

Spine J. Mar-Apr 2005;5(2):155-160.

Spinal Fusion

• Only 46% of those with interbody fusion met all 4 criteria for success (54% of fusion patients did not meet success criteria)

• Even among the patients classified as having a successful result, most were still using narcotic medications at the 2-year follow-up, including 84% in the fusion group

• Complications were reported in 77.8% of the BAK fusion group (77 events in 99 patients)

Blumenthal S, McAfee PC, Guyer RD, et al. A prospective, randomized, multicenter Food

and Drug Administration investigational device exemptions study of lumbar total disc

replacement with the CHARITE artificial disc versus lumbar fusion: part I: evaluation of

clinical outcomes. Spine. Jul 15 2005;30(14):1565-1575; discussion E1387-1591.

Norwegian Manual Therapy Oslo March 2012

Adriaan Louw, PT, PhD (c), M.App.Sc

(physio) 13

Reoperation rates significant following L-fusion

• Patients who had surgery in 1990-93 had a 19% cumulative incidence of reoperation during the subsequent 11 years.

• After fusion surgery, 62.5% of reoperations were associated with a diagnosis suggesting device complication or pseudarthrosis.

Martin BI, Mirza SK, Comstock BA, Gray DT, Kreuter W, Deyo RA. Reoperation rates

following lumbar spine surgery and the influence of spinal fusion procedures. Spine. Feb

1 2007;32(3):382-387.

Cage Fusions

• 63.9% overall disability rate at 2 years after fusion

• 22.1% reoperation rate

• Other complications 11.8%

1. Fenton JJ, Mirza SK, Lahad A, Stern BD, Deyo RA. Variation in reported safety of

lumbar interbody fusion: influence of industrial sponsorship and other study

characteristics. Spine. Feb 15 2007;32(4):471-480.

2. Deyo RA, Gray DT, Kreuter W, Mirza S, Martin BI. United States trends in lumbar

fusion surgery for degenerative conditions. Spine. Jun 15 2005;30(12):1441-

1445; discussion 1446-1447.

Norwegian Manual Therapy Oslo March 2012

Adriaan Louw, PT, PhD (c), M.App.Sc

(physio) 14

Fusing previous back surgery patients

• ODI was significantly improved from 47 to 38 after fusion (REALLY?).

• The success rate was 50% in the fusion group (CAN WE CALL IT A SUCCESS RATE?)

• For patients with chronic low back pain after previous surgery for disc herniation, lumbar fusion failed to show any benefit over cognitive intervention and exercises.

Brox JI, Reikeras O, Nygaard O, et al. Lumbar instrumented fusion compared

with cognitive intervention and exercises in patients with chronic back pain after

previous surgery for disc herniation: a prospective randomized controlled study.

Pain. May 2006;122(1-2):145-155.

Fusion – Summary

• At best – coin toss: 50% success rate

• Significant complications

– Double risks compare to

decompression surgery

– Blood transfusion x 6

– Double postoperative mortality

Deyo RA, Ciol MA, Cherkin DC, Loeser JD, Bigos SJ. Lumbar spinal fusion. A

cohort study of complications, reoperations, and resource use in the Medicare

population. Spine. Sep 1 1993;18(11):1463-1470.

Norwegian Manual Therapy Oslo March 2012

Adriaan Louw, PT, PhD (c), M.App.Sc

(physio) 15

They may be getting the message

Total Disc Arthroplasty

• 57% of the patients with disc replacement met all 4 criteria for success

• 64% still using narcotic medications at the 2-year follow-up, including 64%

30

Blumenthal S, McAfee PC, Guyer RD, et al. A prospective, randomized, multicenter Food

and Drug Administration investigational device exemptions study of lumbar total disc

replacement with the CHARITE artificial disc versus lumbar fusion: part I: evaluation of

clinical outcomes. Spine. Jul 15 2005;30(14):1565-1575; discussion E1387-1591.

Norwegian Manual Therapy Oslo March 2012

Adriaan Louw, PT, PhD (c), M.App.Sc

(physio) 16

Hold On…

• What were the a criteria for success?

– > 25% ODI improvement 24 months postop

– No device failure

– No major medical complications

– No neurological deterioration

Blumenthal S, McAfee PC, Guyer RD, et al. A prospective, randomized, multicenter Food

and Drug Administration investigational device exemptions study of lumbar total disc

replacement with the CHARITE artificial disc versus lumbar fusion: part I: evaluation of

clinical outcomes. Spine. Jul 15 2005;30(14):1565-1575; discussion E1387-1591.

Lumbar Disc Replacement

• TDR with the CHARITE Artificial Disc – 106 follow-up

• Mean follow-up time 13.2 years

• 82.1% – “excellent or good clinical outcome”

• 89.6 % returned to work

• 7.5 % required posterior instrumented fusion

• 4.6% of postoperative facet arthrosis David T. Long-term results of one-level lumbar

arthroplasty: minimum 10-year follow-up of the

CHARITE artificial disc in 106 patients. Spine 32 (6):

661-6, 2007.

Norwegian Manual Therapy Oslo March 2012

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(physio) 17

Lumbar Disc Replacement

• 2 RCTs, 2 previous systematic reviews, 7 prospective cohort studies, 11 retrospective cohort studies and 8 case series

• To date, no study has shown total disc replacement to be superior to spinal fusion in terms of clinical outcome

• Long-term benefits of total disc replacement in preventing adjacent level disc degeneration have yet to be realized

Freeman BJ, Davenport J. Total disc replacement in

the lumbar spine: a systematic review of the

literature. Eur Spine J 15 Suppl 3: S439-47, 2006.

Lumbar Disc Replacement

• Negative selection study

– 75 patients with persistent leg and back pain after insertion of an artificial disc

– Complications – subsidence, wear, adjacent disc degeneration, facet joint degeneration and migration

– 15 – posterior fusion without disc removal

– 22 – removed prostheses and performed a posterior and anterior fusion

Punt IM, Visser VM, van Rhijn LW, Kurtz SM, Antonis J, Schurink GW, van Ooij A.

Complications and reoperations of the SB Charite lumbar disc prosthesis:

experience in 75 patients. Eur Spine J 17 (1): 36-43, 2008.

Norwegian Manual Therapy Oslo March 2012

Adriaan Louw, PT, PhD (c), M.App.Sc

(physio) 18

Lumbar Disc Replacement

• Global Assessment: 30% in the TDR group and 15% in the fusion group were totally pain-free at 2 years

• TDR patients had reached maximum recovery in virtually all variables at 1 year, with significant differences compared to the fusion group.

• Complications and reoperations were similar in both groups

• One year after surgery, TDR was superior to spinal fusion in clinical outcome, but this difference had diminished by 2 years, apart from (VAS for back pain and) numbers of pain-free.

Berg S, Tullberg T, Branth B, Olerud C, Tropp H. Total disc replacement compared to

lumbar fusion: a randomised controlled trial with 2-year follow-up. Eur Spine J. Oct

2009;18(10):1512-1519.

Disc Replacement

Summary

• Results not as impressive as expected

• Lot’s of “hype”

• Better than fusion (coin toss at best)

• At least 30-40% of patients experience persistent pain and disability

Norwegian Manual Therapy Oslo March 2012

Adriaan Louw, PT, PhD (c), M.App.Sc

(physio) 19

Kypho/Vertebroplasty

• Patients of the kyphoplasty group showed an immediate beneficial and significant effect postoperatively, and better outcomes 1 and 3 months after operation compared to the conservatively treated group in pain feeling, mobility and vertebral body height.

• After 12 months the difference between both groups was not significant excepting the vertebral body height.

• There was clinically asymptomatic cement leakages in up to 45% of which we do not know the consequences in long term. Schmelzer-Schmied N, Cartens C, Meeder PJ, Dafonseca K. Comparison of

kyphoplasty with use of a calcium phosphate cement and non-operative therapy in

patients with traumatic non-osteoporotic vertebral fractures. Eur Spine J. May

2009;18(5):624-629.

Kypho/Vertebroplasty

• There are now prospective studies of low bias, with follow-up of 12 months or more, which demonstrate balloon kyphoplasty to be more effective than medical management of osteoporotic vertebral compression fractures and as least as effective as vertebroplasty.

Taylor RS, Fritzell P, Taylor RJ. Balloon kyphoplasty in the management of vertebral

compression fractures: an updated systematic review and meta-analysis. Eur Spine J.

Aug 2007;16(8):1085-1100.

Norwegian Manual Therapy Oslo March 2012

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(physio) 20

Kypho/Vertebroplasty

• A large proportion of subjects had some pain relief, including 87% with vertebroplasty and 92% with kyphoplasty.

• Cement leaks occurred for 41% and 9% of treated vertebrae for vertebroplasty and kyphoplasty, respectively.

• New fractures of adjacent vertebrae occurred for both procedures at rates that are higher than the general osteoporotic population but approximately equivalent to the general osteoporotic population that had a previous vertebral fracture.

• CONCLUSIONS: Lack of comparative, blinded, randomized clinical trials.

Hulme PA, Krebs J, Ferguson SJ, Berlemann U. Vertebroplasty and kyphoplasty: a

systematic review of 69 clinical studies. Spine (Phila Pa 1976). Aug 1 2006;31(17):1983-

2001.

Kypho/Vertebroplasty

• Vertebroplasty did not result in a significant advantage in any measured outcome at any time point.

• There were significant reductions in overall pain in both study groups at each follow-up assessment.

• Similar improvements were seen in both groups with respect to pain at night and at rest, physical functioning, quality of life, and perceived improvement.

• CONCLUSIONS: We found no beneficial effect of vertebroplasty as compared with a sham procedure in patients with painful osteoporotic vertebral fractures, at 1 week or at 1, 3, or 6 months after treatment.

Buchbinder R, Osborne RH, Ebeling PR, et al. A randomized trial of vertebroplasty

for painful osteoporotic vertebral fractures. N Engl J Med. Aug 6 2009;361(6):557-

568.

Norwegian Manual Therapy Oslo March 2012

Adriaan Louw, PT, PhD (c), M.App.Sc

(physio) 21

Kypho/Vertebroplasty

• At 1 month, there was no significant difference between the vertebroplasty group and the control group in either the RDQ score or the pain rating.

• Although the two groups did not differ significantly on any secondary outcome measure at 1 month, there was a trend toward a higher rate of clinically meaningful improvement in pain (a 30% decrease from baseline) in the vertebroplasty group (64% vs. 48%, P=0.06).

• CONCLUSIONS: Improvements in pain and pain-related disability associated with osteoporotic compression fractures in patients treated with vertebroplasty were similar to the improvements in a control group.

Kallmes DF, Comstock BA, Heagerty PJ, et al. A randomized trial of

vertebroplasty for osteoporotic spinal fractures. N Engl J Med. Aug 6

2009;361(6):569-579.

Kypho/Vertebroplasty

• 26% of patients sustained 17 subsequent fractures.

• Of the 17 subsequent fractures, there were nine at the adjacent-above levels, four at adjacent-below levels, and four at remote levels.

• CONCLUSION: This study demonstrated a higher rate of subsequent fracture after kyphoplasty compared with natural history data for untreated fractures.

Fribourg D, Tang C, Sra P, Delamarter R, Bae H. Incidence of subsequent vertebral

fracture after kyphoplasty. Spine. Oct 15 2004;29(20):2270-2276; discussion 2277.

Norwegian Manual Therapy Oslo March 2012

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Kypho/Vertebroplasty

• Refractures of cemented

vertebrae after vertebroplasty

occurred in 63% of

osteoporotic patients.

Lin WC, Lee YC, Lee CH, et al. Refractures in cemented

vertebrae after percutaneous vertebroplasty: a retrospective

analysis. Eur Spine J. Apr 2008;17(4):592-599.

Kypho/Vertebroplasty

• Summary

– No significant evidence over conservative care or placebo

– High incidence of fractures above/below

– Cemented vertebrae fractures also occur

AND – various medical concerns: unknowns of cement

leakage, intravascular leakage, embolisms, bleeding, etc.

US Insurance likely won’t cover the procedure

Norwegian Manual Therapy Oslo March 2012

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(physio) 23

X-Stop

• By 12 months, 54% of the patients reported clinically significant improvement in their symptoms

• 33% reported clinically significant improvement in physical function

• 71% expressed satisfaction with the procedure.

• 29% of the patients required caudal epidural after 12 months after surgery for recurrence of their symptoms of neurogenic claudication.

Siddiqui M, Smith FW, Wardlaw D. One-year results of X Stop interspinous implant for the

treatment of lumbar spinal stenosis. Spine. May 20 2007;32(12):1345-1348.

X-Stop • The mean VAS (leg pain) score in these 175 patients was reduced from

61.2% preoperatively to 39.0% at the first clinical follow-up examination at 6 weeks postoperatively. The mean VAS score at 24 months postoperatively was 39.0%.

• Oswestry score was 32.6% preoperatively, 22.7% at 6 weeks, and 20.3% at 24 months postoperatively on average.

• In eight out of the implanted 175 patients, the X-Stop had to be removed and a microsurgical decompression had to be performed because of unsatisfactory effect of the interspinous distraction device.

• The interspinous device does not replace microsurgical decompression in patients with massive stenosis and continuous claudication, but offers a save, effective and less invasive alternative in selected patients with spinal stenosis.

Kuchta J, Sobottke R, Eysel P, Simons P. Two-year results of interspinous spacer (X-Stop)

implantation in 175 patients with neurologic intermittent claudication due to lumbar spinal

stenosis. European spine journal : official publication of the European Spine Society, the

European Spinal Deformity Society, and the European Section of the Cervical Spine Research

Society. Jun 2009;18(6):823-829.

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(physio) 24

X-Stop

• Summary

– Has yet to show long-term results

– Likely limited time-frame due to

progressive nature of LSS

– Complications: Device failure and

spinous process fractures

Summary

It can easily be stated that at least 1/3 of

lumbar surgery patients continue to

have significant persistent pain,

disability and functional loss.

Norwegian Manual Therapy Oslo March 2012

Adriaan Louw, PT, PhD (c), M.App.Sc

(physio) 25

So – a Second Surgery will fix it…right? • Deyo RA, Mirza SK. The case for restraint in spinal surgery: does quality

management have a role to play? Eur Spine J. Aug 2009;18 Suppl 3:331-337.

• Martin BI, Mirza SK, Comstock BA, Gray DT, Kreuter W, Deyo RA. Reoperation

rates following lumbar spine surgery and the influence of spinal fusion procedures.

Spine. Feb 1 2007;32(3):382-387.

• Martin BI, Mirza SK, Comstock BA, Gray DT, Kreuter W, Deyo RA. Reoperation

rates following lumbar spine surgery and the influence of spinal fusion procedures.

Spine. Feb 1 2007;32(3):382-387.

• Papadopoulos EC, Girardi FP, Sandhu HS, et al. Outcome of revision discectomies

following recurrent lumbar disc herniation. Spine. Jun 1 2006;31(13):1473-1476.

• Brox JI, Reikeras O, Nygaard O, et al. Lumbar instrumented fusion compared with

cognitive intervention and exercises in patients with chronic back pain after previous

surgery for disc herniation: a prospective randomized controlled study. Pain. May

2006;122(1-2):145-155.

• He, S. C., G. J. Teng, et al. (2008). "Repeat vertebroplasty for unrelieved pain at

previously treated vertebral levels with osteoporotic vertebral compression

fractures." Spine (Phila Pa 1976) 33(6): 640-647.

So: No-One Should Have Back Surgery?

• There are VERY DEFINITE indications: – Progressive neurological deficit

– Fractures

– Cord Compression

• Pain?

• Instability?

• Arthritis?

Norwegian Manual Therapy Oslo March 2012

Adriaan Louw, PT, PhD (c), M.App.Sc

(physio) 26

Instability

• What is it?

• How do you diagnose

it?

• What percentage of

“normal” people have

a spondylolisthesis?

(Treat the symptoms)

Arthritis?

• The Lumbar Spine starts aging at age 22-23

• Everyone in the audience is thus a candidate for

surgery – so: don’t sneeze, bend or fart!

Bogduk, N. and L. Twomey (1991). Clinical Anatomy of the Lumbar Spine. London,

Churchill Livingstone.

Taylor, J. R. and L. T. Twomey (1986). "Age changes in lumbar zygapophyseal joints.

Observations on structure and function." Spine (Phila Pa 1976) 11(7): 739-745.

Twomey, L. T. and J. R. Taylor (1987). "Age changes in lumbar vertebrae and

intervertebral discs." Clin Orthop Relat Res(224): 97-104.

Norwegian Manual Therapy Oslo March 2012

Adriaan Louw, PT, PhD (c), M.App.Sc

(physio) 27

Insanity

• Doing the same

thing over and

over again and

expecting

different results