腰椎融合手术的生物力学及研究进展
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Spine Section, Dept. of Orthopaedic Surgery, Aarhus University Hospital, Aarhus, Denmark
Risk factors for high disability at FU
Risk factor
Pathology Pain duration Secondary degeneration^ < 1 year
Smoking as a Predictor of negative Outcome.
426
patt. 54.5% smokers > 10 cigarettes : less patients satisfaction higher risk of nonunion. Smoking cessation for 6 months prior to surgery normalize fusion rates
March 2003 Back pain and neurogenic complication
Adjacent level break down!
May 2003: Decompression and elongation of fusion
August 2003, Increasing pain back pain during 2 months, bed ridden.
Goals in lumbar fusion:
Pain
relief Recovery of neurologic impairment and dysfunction Restore sagittal balance
200.000 Fusions/year in US US-market tripling since 1997 20-30% annual growth
A 63 year old woman with neurogenic claudication and back pain. In 2001 she had segmental decompression and instrumented posterolateral fusion. Primary uncomplicated .
Only few patient-centered such as outcomes for pain, disability and capacity for work. Lack of longterm results and comparison with natural history or conservative treatment. 10 RCTs on instrumented versus noninstrumented fusion- no effect on outcome, higher complication rate with instrumentation. CONCLUSION: No scientific evidence about effectiveness of any form of surgical decompression or fusion for deg lumbar spondylosis
Improved clinical outcome was associated with:
Patient global assessment Score valid VAS scales responsive Pain drawing not predictive.
Non-neurotic personality traits Radiographic signs of severe disc degeneration Young age and short sick leave
Circumferential fusion versus posterolateral fusion.
Fritzell et al. Spine 2002 Christensen et al. Spine 2002
Long-Term Functional Outcome of Pedicle Screw Instrumentation as a Support for Posterolateral Spinal Fusion. Randomized Clinical Study with a 5- Year Follow-up. SPINE 27, 12, 1269, 2002
The Evidence Base Lumbar Spinal Fusion
No effect of pedicle screw instrumentation on functional outcome compared to posterolateral fusion alone in RCT´s!
SOLUTIONS ?
August 2003
•Wedge osteotomy L3 •Decompression L3 & L4 roots
•Cement augmentation L1 & Th 12
CONCENSUS BASED MEDICIN VERSUS EVIDENCED BASED MEDICIN
24 (13-53)g/Level
Fused:
Pseudo : 15 (13-23)g/Level P < 0.006
Laursen 2004
Allograft versus Autograft in Instrumented PLF, Gibson et al. Spine 2002
Fritzell et al Spine 26 , 2001 Fritzell et al Eur Spine J 2003
Patient selection
Surgical technique
Spinal fusion
Surgical methods
Biological Growth factors factors
McGuire &Åmundsson 1993 Fischgrund et al Spine 1997 Thomsen et al Spine 1997 France et al Spine 1999 Møller & Hedlund Spine 2000 Fritzell et al. Spine 2002 Swedish Spine Study Christensen et al Spine 2002.
New Scientific Evidence !
Spine week 2004
•17% complication rate in surgical group •Net back to work rate 36% versus 13% •Overall satisfaction 63% compared to 29%
IS SPINAL FUSION JUSTIFIED IN THE TREATMENT OF LOW BACK PAIN ?
Chronic Low Back Pain
Conservative treatment ?
Surgery ?
Surgical options: Disc surgery Decompression Disc arthroplasty Total disc prosthesis Flexible intervertebral stabil. Fusion Decompression and Fusion
Patient Selection
Patient Selection in CLBP
Measurement and Prediction of Outcome. The Swedish Lumbar Spine Study. O Hagg, P. Fritzell et al. Thesis 2002.
SURGICAL TECHNIQUE
Fusion rates are highly dependent on quantity of autograft. A prospective study.
76 ptt Posterolat. lumbar spine fusion Harvested autograft weighed One year follow up :
The Cochrane Library 2004
(Surgery for degenerative lumbar spondylosis. last update May 2000)
16 RCT´s Serious weaknesses of trial design, poor methods of randomisation, lack of blinding, lack of independent assessment of outcome Mostly technical surgical outcomes
OR
1.61 1*
95% CI
1.08 – 2.40
P-value#
0.020
1-2 years
> 2 years Irradiating pain Work status Yes Working Without work/sick-leave Retired/pensioned Preoperative classification Group 1+2 Group 3 Group 4 Age 40-59 years^
2.70
2.32 1.51 1* 2.84 3.48 1* 2.69 5.53 1.68
0.92 – 7.95
0.87 – 6.17 0.94 – 2.43 1.78 – 4.53 2.08 – 5.82 1.40 – 5.18 2.89 – 10.59 1.13 – 2.49
0.071
0.093 0.091
Lumbar Spinal Fusion The Evidence Base
7th annual Congress of the Chinese Orthopedic Society 2004 Guangzhou, China
Denmark
Trademark important
Acta´s position today, the future
RCT
of 69 pat. Allograft equal to autograft in outcome scores Allograft eliminated the 17% risk of donor site pain
SPINAL FUSION WHICH SURGICAL METHOD ?
Andersen et al. Spine 26, 2623-28, 2001,
Dallas Pain Questionnaire classification predicts outcome in low back pain patients undergoing spinal fusion
Thomas Andersen, Finn Bjarke Christensen, Ebbe Stender Hansen, Peter Helmig, Kristian Hø y, Bent Niedermann, Cody Bü nger
<0.0005 <0.0005 0.003 <0.0005 0.011
OR = Odds Ratio; CI = Confidence Interval. *Denominator (reference group) of following odds ratios. ^Recoded into binary variable. #Associated with the two-tailed test that OR=1.
Risk factors for high disability at FU
Risk factor
Pathology Pain duration Secondary degeneration^ < 1 year
Smoking as a Predictor of negative Outcome.
426
patt. 54.5% smokers > 10 cigarettes : less patients satisfaction higher risk of nonunion. Smoking cessation for 6 months prior to surgery normalize fusion rates
March 2003 Back pain and neurogenic complication
Adjacent level break down!
May 2003: Decompression and elongation of fusion
August 2003, Increasing pain back pain during 2 months, bed ridden.
Goals in lumbar fusion:
Pain
relief Recovery of neurologic impairment and dysfunction Restore sagittal balance
200.000 Fusions/year in US US-market tripling since 1997 20-30% annual growth
A 63 year old woman with neurogenic claudication and back pain. In 2001 she had segmental decompression and instrumented posterolateral fusion. Primary uncomplicated .
Only few patient-centered such as outcomes for pain, disability and capacity for work. Lack of longterm results and comparison with natural history or conservative treatment. 10 RCTs on instrumented versus noninstrumented fusion- no effect on outcome, higher complication rate with instrumentation. CONCLUSION: No scientific evidence about effectiveness of any form of surgical decompression or fusion for deg lumbar spondylosis
Improved clinical outcome was associated with:
Patient global assessment Score valid VAS scales responsive Pain drawing not predictive.
Non-neurotic personality traits Radiographic signs of severe disc degeneration Young age and short sick leave
Circumferential fusion versus posterolateral fusion.
Fritzell et al. Spine 2002 Christensen et al. Spine 2002
Long-Term Functional Outcome of Pedicle Screw Instrumentation as a Support for Posterolateral Spinal Fusion. Randomized Clinical Study with a 5- Year Follow-up. SPINE 27, 12, 1269, 2002
The Evidence Base Lumbar Spinal Fusion
No effect of pedicle screw instrumentation on functional outcome compared to posterolateral fusion alone in RCT´s!
SOLUTIONS ?
August 2003
•Wedge osteotomy L3 •Decompression L3 & L4 roots
•Cement augmentation L1 & Th 12
CONCENSUS BASED MEDICIN VERSUS EVIDENCED BASED MEDICIN
24 (13-53)g/Level
Fused:
Pseudo : 15 (13-23)g/Level P < 0.006
Laursen 2004
Allograft versus Autograft in Instrumented PLF, Gibson et al. Spine 2002
Fritzell et al Spine 26 , 2001 Fritzell et al Eur Spine J 2003
Patient selection
Surgical technique
Spinal fusion
Surgical methods
Biological Growth factors factors
McGuire &Åmundsson 1993 Fischgrund et al Spine 1997 Thomsen et al Spine 1997 France et al Spine 1999 Møller & Hedlund Spine 2000 Fritzell et al. Spine 2002 Swedish Spine Study Christensen et al Spine 2002.
New Scientific Evidence !
Spine week 2004
•17% complication rate in surgical group •Net back to work rate 36% versus 13% •Overall satisfaction 63% compared to 29%
IS SPINAL FUSION JUSTIFIED IN THE TREATMENT OF LOW BACK PAIN ?
Chronic Low Back Pain
Conservative treatment ?
Surgery ?
Surgical options: Disc surgery Decompression Disc arthroplasty Total disc prosthesis Flexible intervertebral stabil. Fusion Decompression and Fusion
Patient Selection
Patient Selection in CLBP
Measurement and Prediction of Outcome. The Swedish Lumbar Spine Study. O Hagg, P. Fritzell et al. Thesis 2002.
SURGICAL TECHNIQUE
Fusion rates are highly dependent on quantity of autograft. A prospective study.
76 ptt Posterolat. lumbar spine fusion Harvested autograft weighed One year follow up :
The Cochrane Library 2004
(Surgery for degenerative lumbar spondylosis. last update May 2000)
16 RCT´s Serious weaknesses of trial design, poor methods of randomisation, lack of blinding, lack of independent assessment of outcome Mostly technical surgical outcomes
OR
1.61 1*
95% CI
1.08 – 2.40
P-value#
0.020
1-2 years
> 2 years Irradiating pain Work status Yes Working Without work/sick-leave Retired/pensioned Preoperative classification Group 1+2 Group 3 Group 4 Age 40-59 years^
2.70
2.32 1.51 1* 2.84 3.48 1* 2.69 5.53 1.68
0.92 – 7.95
0.87 – 6.17 0.94 – 2.43 1.78 – 4.53 2.08 – 5.82 1.40 – 5.18 2.89 – 10.59 1.13 – 2.49
0.071
0.093 0.091
Lumbar Spinal Fusion The Evidence Base
7th annual Congress of the Chinese Orthopedic Society 2004 Guangzhou, China
Denmark
Trademark important
Acta´s position today, the future
RCT
of 69 pat. Allograft equal to autograft in outcome scores Allograft eliminated the 17% risk of donor site pain
SPINAL FUSION WHICH SURGICAL METHOD ?
Andersen et al. Spine 26, 2623-28, 2001,
Dallas Pain Questionnaire classification predicts outcome in low back pain patients undergoing spinal fusion
Thomas Andersen, Finn Bjarke Christensen, Ebbe Stender Hansen, Peter Helmig, Kristian Hø y, Bent Niedermann, Cody Bü nger
<0.0005 <0.0005 0.003 <0.0005 0.011
OR = Odds Ratio; CI = Confidence Interval. *Denominator (reference group) of following odds ratios. ^Recoded into binary variable. #Associated with the two-tailed test that OR=1.