BENEVERMEDEX...If a fusion is redone, the chances of being disabled 2 years later increased by 25 %...

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BENEVERMEDEX – WVV 6 de wetenschappelijk symposium 16 november 2019 Leuven SNIJDEN OF NIET : LUMBALE WERVELZUIL PROF. DR J. VERLOOY UNIVERSITEIT ANTWERPEN GZA ZIEKENHUIZEN ANTWERPEN HÔPITAL ERASME, ULB, BRUXELLES

Transcript of BENEVERMEDEX...If a fusion is redone, the chances of being disabled 2 years later increased by 25 %...

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BENEVERMEDEX – WVV6de wetenschappelijk symposium

16 november 2019 Leuven

SNIJDEN OF NIET : LUMBALE WERVELZUIL

PROF. DR J. VERLOOY

UNIVERSITEIT ANTWERPEN

GZA ZIEKENHUIZEN ANTWERPEN

HÔPITAL ERASME, ULB, BRUXELLES

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Low-back pain due to

lumbar spondylosis

Prevalence : worldwide : 3,6 % USA : 4,5 %

2010 : 83 000 000 quality adjusted life years lost

Increasing rate of diagnosis and surgery of lumbar spondylosis

Increasing number of patients undergoing unsuccesful fusion

operations

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Indications for lumbar fusion

operations

Continue to evolve : new techniques, technologies, outcome

research

Lumbar instability, spinal alignment, fusion rate (><pseudartrosis)

Less invasive techniques : lowers treshold for surgery

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Snijden of niet : lumbale wervelzuil

WETENSCHAP

TECHNIEK

ORGANISATIE

PATIENT

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Snijden of niet : lumbale wervelzuil

WETENSCHAP

TECHNIEK

ORGANISATIE

PATIENT

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EVIDENCE BASED MEDICINE

Class I Level 1 recommendation

prospective, randomized, controlled trials

Class II Level 2 recommendation

non randomized, prospective controlled trials

Observational studies

Class III Level 3 recommendation

Case series

Case reports

Expert opinion

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Evidence Based Medicine:

Spine

• Lumbar HNP (3)

• Lumbar stenosis (3)

• Degenerative spondylolisthesis (5)

• Axial LBP (4)

• Artificial disc (3)

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EBM – spine : Lumbar HNPPeul WC et al : NEJM 2007

Design

Multicenter RCT with ITT analysis

Patients

141 patients early surgery (median : 1.9 weeks)

142 patients non operative management

Results

Early surgery resulted in faster recovery

No difference in outcomes in 1 year

Limitations

High cross-over rates

11 % of surgery to conservative

39 % of conservative to surgery

Blinding not possible

Follow-up only 1 year

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Low back painspondylosis (DegenerativeDiscDisease)

PLIFPosterior

Lumbar

Interbody

Fusion

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EBM: Axial Low Back PainLumbar Fusion Versus Treatment of Chronic Low Back Pain:

A Multicenter Randomized Controlled Trial From the Swedish Spine Study Group Fritzell P, et al Spine 2001

DesignMulticenter RCT with 2 year follow, ITT Analysis

Patients

292 (Fusion 222, Non-operative 72)

Results

Fusion may lead to better outcome

Strengths

Multicenter RCT small dropout (5 patients)

LimitationsNo standardization in either group Industry fundingAsymmetry of group sizes 75 (due to design as multiple fusion arms)

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EBM: Axial Low Back PainRandomized Controlled Trial to Compare Surgical Stabilization of the Lumbar spine with Intensive

Rehabilitation for Patients with Chronic Low Back Pain: The MRC Spine Stabilization Trial. Fairbank et al BMJ 2005

Design

Multi-centre RCT with 2 year follow-up

Patients349 Patients (179 Surgery, 170 Rehab)

Results

Improvement above rehabilitation in ODI (4.1) with surgery (barely statistically significant)

StrengthsMulticenter RCTMultiple outcome measures (ODI, walking test, SF36, work status)

Limitations

High crossover (28% non-operative to rehabilitation) Included redo’s and spondylolisthesisFlexible stabilisations included as fusion

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EBM: Axial Low Back PainRandomized Clinical Trial of Lumbar Instrumented Fusion

and Cognitive Intervention in Patients with Chronic Low Back Pain and Disc Degeneration. Brox et al Spine 2003

Design

RCT with 1 year follow-up

Patients

64 patients

Results

Both groups improved significantly and equally

StrengthsBlinding of physical therapy evaluator Standardized nonsurgical treatment

LimitationsShort follow-up Small numbersLack of no treatment armFailure of treatment in assigned group (4/37 of the surgery group and 2/27 in non-surgical)

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Design

Nationwide (Norway) RCT with 1 year follow-up and ITT Analysis

Patients

60 Patients

Results

No Difference

Strengths

RCT

Validated outcome measures

Blinding of PT evaluator

LimitationsShort follow-up (1year)

Small numbers

Lack of no treatment arm

7/29 Did not have surgery, 2/31 Did not have non-surgical

EBM Spine: Axial LBPLumbar Instrumented Fusion Compared with Cognitive Interventionand Exercises in Patients with Chronic Low Back Pain After Previous

Surgery for Disc Herniation: A Prospective Randomized Controlle

Study. Brox et al Pain 200

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Recent review article

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AANS standard

“Lumbar fusion is recommended as a treatment for carefully

selected patients with disabling low back pain due to

one- or two level degenerative disease without stenosis of

spondylolisthesis”

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Washington State Department of Labor & Industries

Medical treatment guidelines

What you should know about lumbar fusion surgery :

2/3 of workers are still disabled 2 years later

> 50 % of the workers felt that neither their pain nor their ability to function were

better after surgery

1/4 received another operation within 2 years

If a fusion is redone, the chances of being disabled 2 years later increased by 25 %

Smoking at the time of fusion greatly increases the risk of failed fusion

The use of spine stabilization hardware (metal devices) doubled the chances of

needing another surgery (1/2)

Pain relief, even when present, is not likely to be complete

Some lumbar fusion patients have died while taking pain medicine (opioids) following

surgery. The chances of dying were even higher for those whose fusion was for

degenerative disc disease or who had a fusion of more than one vertebral level.

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Washington State Department of Labor & Industries

Health technology clinical committee (HTCC)

20 November 2015 : non-coverage decision for lumbar spinal fusion

operation for degenerative disc disease (DDD)

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Surgeons’s answer :

EBM – Spine : not only RCT

“RCT & Observational study design typically yield the same

answer” Benson K, Hartz AJ, NEJM 2000

Cancato et al NEJM 2000

OBSERVATIONAL STUDY

• Lower costs

• Easier patient recruitment

RCT

Extremely Expensive And Work

Intensive

• 3 SPORT Studies - $12 million

• Difficult to obtain long term

follow-up (SPORT IDH 35% lost

to follow-up at 4 years).

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Snijden of niet : lumbale wervelzuil

WETENSCHAP

TECHNIEK

ORGANISATIE

PATIENT

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Percutane technieken

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Adjacent segment disease (ASD)

adjacent segment disease, defined as the development of clinical

symptoms of radiculopathy or myelopathy caused by radiographicdegeneration (disc height loss, posterior osteophyte formation, all

osteophyte formation, etc.) at motion segment(s) adjacent to the

surgical levels.

Dynamic stabilisation ?

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Failed back surgery syndrome (FBSS)

Failed back surgery syndrome (also called FBSS, or failed back

syndrome) is a misnomer, as it is not actually a syndrome - it is a very generalized term that is often used to describe the condition of

patients who have not had a successful result with back surgery or

spine surgery and have experienced continued pain ...

Voorafbestaande toestand ivm “pijn”

Niet ge-indiceerde operaties : pijn blijft of verergert

neuropathische pijn

Littekenweefselvorming, fibrose rondom neurale structuren

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surgical approaches lumbar spine

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WETENSCHAP

TECHNIEK

ORGANISATIE

PATIENT

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Organisatie van de gezondheidszorg

Ziekenhuis wordt gerund als bedrijf : winst

Vergoeding per prestatie

Associaties van artsen

Industrie “ondersteunt”

Geen coherent doorverwijsbeleid

Multidisciplinair overleg binnen ziekenhuis : ???

Herziening van de nomenclatuur voor spinale chirurgie

Nieuwe ontwikkelingen : sagittal balance chirurgie, …

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Sagittal balance surgery

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“Unnecessary” spinal surgery : a prospective 1-year study of

one surgeon’s experience

Epstein N and Hood D.

Surg.Neurol.Int. 2011, 2:83

COMMENTS

3 reasons : greed, ignorance, stupidity (Portnoy H)

MMPI (Minnesota Multiphasic Personality Inventory) : the most common psychological finding on exam and testing is somatization, the conversion of emotional stress into bodily

complaints and a bodily focus so intense that normal bodily functions are

interpreted als painful. Secondary gain psychologically also play a significant

role (Pawl R.)

Decline in the importance given to history and physical examination (Watts C)

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????

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Snijden of niet : lumbale wervelzuil

WETENSCHAP

TECHNIEK

ORGANISATIE

PATIENT

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IT IS MUCH MORE IMPORTANT TO KNOW

WHAT SORT OF PATIENT HAS A DISEASE

THAN

WHAT SORT OF DISEASE A PATIENT HAS

SIR WILLIAM OSLER

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Predictors of multidimensional outcome after spinal

surgery

A.F. Mannion, A. Elfering, R. Staerkle

Eur Spine J. 2007 June ; 16 (6) : 777 – 786

“… a large proportion of the variance in its scores

after surgery could be predicted by “well-known”

medical and psychosocial predictor variables. This

substantiates the recommendation for its further use

in registry systems, quality management projects

and clinical trials .”

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Snijden of niet : lumbale wervelzuil

degeneratieve lage rugpijn : patiënt

Retrospectieve analyse soms zeer verhelderend

Wanhopige patiënt : “er moet IETS gebeuren”.

Pijn : multipele factoren, chronische pijn, …

Wanneer de operatie uiteindelijk nutteloos is gebleken, ervaart de patiënt dit toch als tijdelijk nuttig in de gegeven acute situatie. Dus

weinig verwijten naar de chirurg toe.

Patiënten laten zich soms vlot meerdere malen opereren

“shopping” bij andere chirurgen, wanneer onvoldoende gunstig

resultaat

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Snijden of niet : lumbale wervelzuil

degeneratieve lage rugpijn

CONCLUSIE

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A good surgeon knows how to operate

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A good surgeon knows how to operate

A better surgeon knows when to

operate

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A good surgeon knows how to operate

A better surgeon knows when to operate

The best surgeon knows when NOT to

operate

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VRAGEN ???COMMENTAAR ?

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patiënt

chirurg

Collega’s

associatie

ziekenhuis

industri

e

technologie

omgevingsfact

oren

Wetenschappel

ijke output

Snijden of niet snijden : axiale wervelzuil

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Radiology

Complementary Medicine

Neurology

Medicine Psychology

Orthopedics

PhysicalSurgery

Therapy

CornellSpine Center

Physiatry / Pain

Management

For 95% of patients:

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EBM-Spine: Lumbar HNP

Peul WC et al NEJM 2007

DesignMulticenter RCT with ITT Analysis

Patients141 Patients- early surgery (median: 1.9 weeks) 142 Patients- non-operative management

ResultsEarly surgery resulted in faster recovery No difference in outcomes in 1 year

LimitationsHigh cross-over rates

11% of surgery conservative39% of conservative surgery

Blinding not possible Follow-up only 1 year

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EBM Spine: Lumbar HNP

Atllas SJ, et. al. Spine 2005 (Maine Lumbar Spine Study)

Design

Prospective Cohort Study (observational)

Patients

235 Surgery

272 Conservative

Results

Surgery: Improved in pain, function and satisfaction outcomes at 1, 5 and 10 years.

No difference in work status, surgery vs. conservative. Benefit of surgery narrowed between the two groups over time but still statistically different at 10 years.

Limitations

Imaging not required

Mail in questionnaire rather than actual clinical exam.

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EBM Spine: Lumbar HNPSpine Patient Outcomes Trial (SPORT)

Weinstein JN , et.al. JAMA 2006, Spine 2008

Design2 Combined Trials (Due to protocol non-adherence)

RCT- 501 Patients

Observational Cohort- 743

Patients

1244 total

Results

Surgery resulted in greater improvement compared with non-operative treatment at 4 years.

Limitations

Cross over (40% of surgery group, 45% of non-operative). This precluded meaningful analysis of the data on an ITT basis because the 2 groups were very similar in treatment received at 2 years.

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LUMBAR STENOSIS

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EBM Spine: StenosisThe Finnish Spinal Stenosis Study

Simotas A.C., Clin. Orthopedic Relat Res 2001

DesignRCT with ITT Analysis

Patients

94 Patients, (50 Surgical, 44 Non-surgical)

Results

Surgery better in ODI, leg and back pain. Greater difference at 1 year than at 2 years

Crossover rate 10% (low) in either direction.

Level I evidence favoring surgery but not in walking ability

Limitations

Small number of patients

20% of surgery group had instrumented fusion (variation in surgical management)

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EBM Spinal: StenosisMaine Lumbar Study Atlas SJ et al, Spine 2005

DesignProspective observational Cohort

10 year follow-up

Patients

148 Patients- (81 Surgical, 67 Nonsurgical)

Results

Level 2 evidence that decompression MAY provide better outcomes over nonsurgical treatment.

LimitationsCross over to surgery 39%Non-randomized: more severe patients to surgery.Few patients with mild symptoms were treated with surgery

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EBM Spine: StenosisSport Trial for Lumbar Spinal Stenosis

Weinstein J, et. al., NEJM 2008, Spine 2010Design

RCT with prospective observational Cohort

Patients654 Patients (289 RCT, 365 Observational)

Results

Level 2 evidence to suggest that surgery results in better outcome at 2 years and maintained at 4 years.

LimitationsHigh cross over– 33% of surgery group to non-surgery group– 43% from non-surgery group had surgery

Surgical treatment variable (11% had a fusion) Non-surgical treatment not specified

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DEGENERATIVE SPONDYLOLISTHESIS

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EBM:Degenerative Spondylolisthesis

Surgical vs. Nonsurgical Treatment for LumbarDegenerative Spondylolisthesis

Weinstein J. et. al. NEJM 2007, JBJS 2009

DesignRCT with prospective observational cohort

(304 RCT, 303 Observational Cohort)

Patients521 Patients Follow-up, (372 Surgery, 149 No-surgery)

Results

Surgery patients (laminectomy with 1 level fusion) had substantially greater pain relief and improvement in function at 4 years.

LimitationsHigh level of cross over, difficult to interpret ITT analysis

36% of surgery group, 49% of non-operative group

Non-operative treatment not standardized

Surgical treatment not standardized

(fusion posteriorly or circumferentially with or without instrumentation)

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EBM:Degenerative SpondylolisthesisThe Surgical Management of Degenerative Lumbar

Spondylolisthesis: A Systemic Review. Martin CR et.al. Spine 2007

Design

Literature Review: RCT and comparative observational studies in English, German and French (1966-2005)

Patients13 Studies of 578 patients

Results

Fusion is more effective than laminectomy in achieving a satisfactory outcome

Instrumentation increased fusion rate

Decompression only had the least satisfactory outcome

Limitations

Some studies included non-consecutive patients

Some had undefined follow-up

No standardized outcome measure was used consistently

Strenghts

Comprehensive review on degenerative spondylolisthesis

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EBM: Degenerative Spondylolisthesis”Degenerative Lumbar Spondylolisthesis with Spinal

Stenosis” Kornblum, et.al. Spine 2008

Design

A Prospective Long Term Study “Comparing Fusion and Pseudoarthrosis”

Patients58 Patients with laminectomy and non-instrumented fusion

ResultsGood or excellent outcome in 86% fusion56% non-union

25/47 (53%) developed non-union

Strengths

Follow-up was long (5-14 years)

Limitations Small number

Non-standardized outcome measure 19% (11 patients) lost to follow-up Single center, secondary analysis

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EBM:Degenerative SpondylolisthesisSurgical Treatment of Spinal Stenosis with

Spondylolisthesis: Cost Effectiveness after 2 years Tosteson AN et al, Ann Internal Medicine 2008

DesignProspective Cohort Study

Patients

601 Patients (randomized and observational cohort)

368 Surgery (fusion in 93% / 78% instrumentation)

233 Non-surgery

Results

A trend toward improved cost effectiveness with circumferential instrumented fusion

Surgery results in better improvement of health

Strengths

Multicenter study

Large number of patientsRCT and observational patients

Validated outcome measure used

Limitations

Non-operative care not specifiedCosts relied upon self-reported utilization data

Follow-up limited to 2 years

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Evidence Based Medicine

Level 1 recommendation

Class I evidence

Level 2 recommendation

Class II evidence

Level 3 recommendation

Class III evidence

Page 79: BENEVERMEDEX...If a fusion is redone, the chances of being disabled 2 years later increased by 25 % Smoking at the time of fusion greatly increases the risk of failed fusion The use

Percutane technieken voor lumbale fusie

Page 80: BENEVERMEDEX...If a fusion is redone, the chances of being disabled 2 years later increased by 25 % Smoking at the time of fusion greatly increases the risk of failed fusion The use
Page 81: BENEVERMEDEX...If a fusion is redone, the chances of being disabled 2 years later increased by 25 % Smoking at the time of fusion greatly increases the risk of failed fusion The use

Voorbeeld van een RCT die de

neurochirurgische praktijk onmiddellijk en

drastisch veranderde

NEJM

Failure of Extracranial-Intracranial Arterial Bypass to Reduce the Risk

of Ischemic Stroke

Results of an internationa Randomized Trial

The EC/IC Bypass Study Group

November 7, 1985, 313 : 1191-1200


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