Cervical Spinal Fusion For Degenerative Disc Disease
20, 2012
Health Technology Assessment
Cervical Spinal Fusion For Degenerative Disc Disease
Final Evidence Report
February 21, 2013
Health Technology Assessment Program (HTA) Washington State Health Care Authority PO Box 42712 Olympia, WA 98504-2712 (360) 725-5126 hta.hca. shtap@hca.
FINAL APPRAISAL DOCUMENT
CERVICAL SPINAL FUSION FOR DEGENERATIVE DISC DISEASE
February 21, 2013
Daniel A. Ollendorf, MPH, ARM Jennifer A. Colby, PharmD Christopher Cameron, MSc Swetha Sitaram, MS Steven D. Pearson, MD, MSc, FRCP
Chief Review Officer Sr. Research Associate Decision Scientist Research Associate President
? 2013, Institute for Clinical and Economic Review
Health Technology Assessment
February 21, 2013
CONTENTS
ABOUT ICER...............................................................................................................................ii
EXECUTIVE SUMMARY .......................................................................................................... 1
ICER INTEGRATED EVIDENCE RATING ? Fusion v Conservative Management .. 25
ICER INTEGRATED EVIDENCE RATING ? Fusion v Discectomy/Foraminotomy . 27
FULL APPRAISAL REPORT .................................................................................................. 35
Background .......................................................................................................................... 35 The Alternative Treatment Strategies ............................................................................. 51 Clinical Guidelines............................................................................................................. 57 Medicare and Representative Private Insurer Coverage Policies.............................. 59 Previous Systematic Reviews/Tech Assessments......................................................... 60 Ongoing Clinical Studies .................................................................................................. 62 The Evidence........................................................................................................................ 64 Clinical Benefits .................................................................................................................. 76 Potential Harms ................................................................................................................... 84 Differential Effectiveness & Safety of Cervical Fusion in Key Patient Subgroups ................................................................................................................................................. 89 Recommendations for Future Research ........................................................................ 110
REFERENCES .......................................................................................................................... 112
APPENDIX A ........................................................................................................................... 129
APPENDIX B............................................................................................................................ 138
Cervical Spinal Fusion ? Final Evidence Report
Page i
Health Technology Assessment
February 21, 2013
ABOUT ICER
The Institute for Clinical and Economic Review (ICER), based at the Massachusetts General Hospital's Institute for Technology Assessment (ITA), provides independent evaluation of the clinical effectiveness and comparative value of new and emerging technologies. ICER's mission is to lead innovation in comparative effectiveness research through methods that integrate evaluations of clinical benefit and economic value. By working collaboratively with patients, clinicians, manufacturers, insurers and other stakeholders, ICER develops tools to support patient decisions and medical policy that share the goals of empowering patients and improving the value of healthcare services.
ICER's academic mission is funded through a diverse combination of sources; funding is not accepted from manufacturers or private insurers to perform reviews of specific technologies. Since its inception, ICER has received funding from the following sources:
Aetna Foundation The Agency for Healthcare Research & Quality (AHRQ) America's Health Insurance Plans (AHIP) Amgen, Inc. Blue Cross Blue Shield of Massachusetts Blue Shield of California Foundation Greater Boston Chamber of Commerce Harvard Pilgrim Health Care HealthPartners The John W. Rowe Family Foundation Johnson & Johnson Kaiser Permanente Merck & Co. The National Pharmaceutical Council Philips Healthcare Robert Wood Johnson Foundation United Health Foundation The Washington State Health Care Authority
More information on ICER's mission and policies can be found at icer-.
Cervical Spinal Fusion ? Final Evidence Report
Page ii
Health Technology Assessment
February 21, 2013
EXECUTIVE SUMMARY
Introduction
Chronic neck pain is a prevalent and costly disorder. Approximately 15-20% of adults report at least one episode of neck pain during a given year, and nearly half of these individuals seek care (Carroll, 2008). On an annual basis, it is estimated that 11-14% of workers will have some limitation in their activities due to neck pain (C?t?, 2008). While no recent studies have been conducted in the US on the economic burden of neck pain specifically, the combined burden of neck and back disorders in this country has been estimated to total $86 billion (Deyo, 2008).
One of the common causes of chronic neck pain is the progression of degenerative disc disease (DDD) of the cervical spine, a natural consequence of aging that results in gradual deterioration of cervical intervertebral discs (Emery, 2001). As the ability of these discs to absorb the shock and stress of vertebral motion declines, they become inelastic and cause a settling of the spinal column structure and abnormal spinal motion patterns. This process may in turn cause the development of abnormal bony growths and/or spurs (spondylosis), osteoarthritis, and/or herniation of one or more cervical discs. All of these conditions may in turn cause radiculopathy, or peripheral nerve root impingement. Symptoms of cervical radiculopathy include neck and arm pain, and weakness, tingling, or numbness in the upper extremities (Mayo Clinic, 2012). Less commonly, cervical DDD progression and its sequelae may directly compress parts of the spinal cord (myelopathy), affecting gait and balance in addition to causing arm and/or leg weakness and numbness.
A variety of management options are available to treat cervical neck pain and related symptoms arising from degenerative disc disease. These options are described in detail in the main body of the report. Briefly, the major options include:
Conservative Treatment
- Physical Therapy - Cervical Collar Immobilization - Spinal Manipulation (i.e., chiropractic or manual physical therapy) - Medication (e.g., analgesics, muscle relaxants, opioids) - Alternative Treatments (e.g., yoga, acupuncture) - Self-Care (e.g., educational materials, home stretching)
Cervical Spinal Fusion ? Final Evidence Report
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