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Does the Increase in Spine Surgery Reflect an Increase in
Disease?
Sohail K. Mirza, MD MPHProfessor, Department of Orthopedics and
Joint Professor, Department of Neurological Surgery
University of Washington
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X UW Tech Transfer (Synthes)
X
XDepuy, Surgical Dynamics, Synthes(to UW Dept. of Orthopedics)
Depuy, Synthes (to Dept of Orthop)
X
XX
XXX
XXX
XX
X
NASS Format
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Disclosure• I hold the University of Washington Surgical
Dynamics Endowed Chair for Spine Outcomes Research (approx $90k in 2006).
• I receive royalties for surgical drills licensed by Synthes Spine through UW Office of Technology Transfer (approx. $16k in 2006).
• UW Department of Orthopedics receives spine fellowship support, research support, and endowments from Synthes Spine and Depuy Spine. I work with the spine fellows and am involved with two of the research projects supported by these funds.
• I prepared all the slides. Sohail K. Mirza, MD, MPH
Professor, Department of Orthopedics and Sports Medicine
and Department of Neurological Surgery, University of Washington
Harborview Medical Center, Box 359798
325 Ninth Avenue
Seattle, WA 98104
Email: [email protected] Tel: 206 731 3658 Fax: 206 731 3227
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no
Does the increase in spine surgery reflect an increase in disease?
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1,865,196 results on 5/17/2002
Back Pain
707,000,000 results on 6/ 5/200726,100,000 results on 1/15/2008
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Resolution of pedicle screw litigation
New posterior fixation devices
New anterior fixation devices
Cages
Bone graft substitutes
Bone morphogenetic proteins
Minimally invasive spine surgery
Computer-assisted surgery
Artificial discs
New Technologies
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1. Fusion results in better pain and function outcome in patients with spondylolisthesis.
2. Fusion with instrumentation results in a higher fusion rate.
3. Instrumentation is associated with a higher complication rate.
4. Artificial disc replacement may avoid complications of fusion.
New Clinical Knowledge: RCTs
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Normal
Degeneration
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Biochemical Changes
• Water content
• Proteoglycan content
• Chondroitin to sulfate ratio
• Collagen network
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Collagen
Repetitive Sequence (GLY – X – Y )
X: proline
Y: hydroxyproline
Triple helix
Tryptophan substitution?
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Ala-Kokko Science 1999JAMA 2001 Spine 2002
Col9A2: Glutamine TryptophanDisc disease 6/157 (vs. 0/174 controls)
COL9A3: Arginine TryptophanDisc disease 12% (vs. 5% controls)
Trp allele 3X risk for disc disease
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Association with Collagen IX Tryptophan Alleles
Matsui, Mirza, Eyre JBJS-B 2004
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Association with Collagen IX Tryptophan Alleles
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Spinal Stenosis with Spondylolisthesis
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Potential Physiological Basis for Disc-associated Back Pain
• Initiation of a chemotactic response
• Vascular ingrowth
• Increased sensory innervation
• Endplate cartilage defects
• Inflammation
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Variation
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Ratio of Back Surgery Rates
Deyo, Mirza CORR 2006
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Weinstein, Lurie et al Spine 2006
Variation in Lumbar Fusion Rates
Per 1000 Medicare Enrollees 2002-2003
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Low-rate states High-rate statesHawaii 1.8 Montana 7.4Vermont 2.6 Oregon 7.5New Jersey 2.7 Idaho 8.4New York 2.7 Wyoming 9.2
Low-rate cities High-rate citiesTerre Haute, IN 1.6 Ft. Collins, CO 8.0Bronx, NY 1.7 Eugene, OR 8.0Honolulu, HI 1.8 Idaho Falls, ID 8.2Wilkes-Barre, PA 2.0 Slidell, LA 8.2Manhattan, NY 2.1 Amarillo, TX 8.3McAllen, TX 2.1 Newport News, VA 8.3Huntington, WV 2.2 Billings, MT 8.4Hackensack, NJ 2.2 Greeley, CO 8.6Lebanon, NH 2.3 Rapid City, SD 8.6Newark, NJ 2.3 Casper, WY 9.5East Long Island, NY 2.3 Boise, ID 9.9Paterson, NJ 2.4 Bend, OR 10.2
Overall U.S. Rate 4.5
Geographical Variations in Spine Surgery Rates(rate per 1,000 enrollees within the 2001 U.S. Medicare population)
Deyo, Mirza CORR 2006
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Weinstein, Lurie et al Spine 2006
Variation in Lumbar Fusion Rates
Rate Per 1000 Medicare Enrollees
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Laminectomy Fusion
Variation in
Regional Rates 8X 20X
Weinstein, Lurie et al Spine 2006
Variation in Lumbar Surgery Rates
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Causes of Variation• Lack of scientific evidence
• Financial Incentives and Disincentives
• Clinical Training and Professional Opinion
• New technology
Weinstein, Lurie et al Spine 2006
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Growth
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Lumbar Fusions forDegenerative
DiseaseHip
ReplacementKnee
ArthroplastyNumber of procedures, 2001(listed as primary procedure) 122,316 329,900 363,536
% increase in volume 1996-2001 113% 13% 15%
Mean hospital stay, days 4.5 5.4 4.5
Median hospital stay, days 4 4 4
Mean total hospital charges, 2001 $39,900 $28,234 $25,309
Median total hospital charges $26,887 $24,017 $22,335
National Hospital Bill, 2001(mean charges times no. of hospitalizations) $4.9 Billion $9.3 Billion $9.2 Billion
Procedure Comparisons (2001)
Deyo, Nachemson, Mirza NEJM 2004
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Deyo, Nachemson, Mirza NEJM 2004
Annual Number of Operations in U.S.
Data from National Inpatient Sample, HCUP/AHRQ
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Weinstein, Lurie et al Spine 2006
Inpatient Medicare Reimbursement
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1992 2003Rate of Lumbar Fusion 30 per 100k 110 per 100k
Spending for Lumbar Fusion $75 million $482 million
Percent Spending for Fusion 14% 47%
Weinstein, Lurie et al Spine 2006
Inpatient Medicare Reimbursement
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Deyo, Mirza et al Spine 2005
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Deyo, Mirza et al Spine 2005
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Deyo, Mirza et al Spine 2005
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Deyo, Mirza et al Spine 2005
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Deyo, Mirza et al Spine 2005
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Deyo, Mirza et al Spine 2005
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Office Visits for Back Pain
Deyo, Mirza, Martin Spine 2006
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National Health Interview Survey 2002
Deyo, Mirza, Martin Spine 2006
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National Health Interview Survey 2002
Deyo, Mirza, Martin Spine 2006
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National Health Interview Survey 2002
Deyo, Mirza, Martin Spine 2006
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US Prevalence of Back Pain
Deyo, Mirza, Martin Spine 2006
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US Prevalence of Back Pain
Deyo, Mirza, Martin Spine 2006
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Potential Financial Conflicts of Interest
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Favorable Results in Industry-Sponsored Research
Sponsor Odds Ratio 95% CISponsor of study 3.6 2.6 to 4.9
For-profit organizations 5.3 2.0 to 14.4
Manufacturer of drugs 8.0 1.1 to 53.2
Spinal device manufacturer 3.3 2.4 to 4.5
Jacobs, Galante, Mirza, Zdeblick JBJS 2006
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Favorable Results
Field Industry-fundedIndependent
Spine 73% 44%
Hip 93% 37%
Knee 75% 20%
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April 8, 2002
“Surgeons have often touted procedures that ultimately proved to be disappointing.”
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“Trisha Bryant assumed that the procedures her surgeon recommended were necessary and had been validated by research. I, too, made that assumption….If Trisha had explored the medical literature, however, she would have
discovered that every aspect of her case– the interpretation of the MRI scan, the diagnosis of spinal instability, the rationale for fusing vertebrae, the impending
discography– was controversial…”
April 8, 2002
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“Each approach to diagnosis and treatment is essentially a franchise, and there are too many franchises battling.”
Seth WaldemanPain Medicine, HSS
April 8, 2002
“Spinal instability is routinely given as a diagnosis to these patients with chronic lower-back pain. It is a term used to justify an operation. And it is a great diagnosis, because it can’t be directly disproved.”
Surgeon who performs two to three spinal fusions a week.
“… within the surgical profession there’s a curious gap between rhetoric and reality.”
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Conclusions• Biological basis for “discogenic back pain” is not known.
• Rates of lumbar fusion for chronic back pain have increased without increase in prevalence of back pain.
• Investigator-sponsor financial conflicts are common.
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Thank you.