benevermedex...if a fusion is redone, the chances of being disabled 2 years later increased by 25 %...
TRANSCRIPT
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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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Snijden of niet : lumbale wervelzuil
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
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Percutane technieken voor lumbale fusie
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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