BACKGROUND: Cervical spondylotic myelopathy (CSM) is the most common cause of spinal cord dysfunction.
OBJECTIVE: To determine the feasibility of a randomized clinical trial comparing the clinical effectiveness and costs of ventral vs dorsal decompression with fusion surgery for treating CSM.
METHODS: A nonrandomized, prospective, clinical pilot trial was conducted. Patients ages 40 to 85 years with degenerative CSM were enrolled at 7 sites over 2 years (2007-2009). Outcome assessments were obtained preoperatively and at 3 months, 6 months, and 1 year postoperatively. A hospital-based economic analysis used costs derived from hospital charges and Medicare cost-to-charge ratios.
RESULTS: The pilot study enrolled 50 patients. Twenty-eight were treated with ventral fusion surgery and 22 with dorsal fusion surgery. The average age was 61.6 years. Baseline demographics and health-related quality of life (HR-QOL) scores were comparable between groups; however, dorsal surgery patients had significantly more severe myelopathy (P < .01). Comprehensive 1-year follow-up was obtained in 46 of 50 patients (92%). Greater HR-QOL improvement (Short-Form 36 Physical Component Summary) was observed after ventral surgery (P = .05). The complication rate (16.6% overall) was comparable between groups. Significant improvement in the modified Japanese Orthopedic Association scale score was observed in both groups (P < .01). Dorsal fusion surgery had significantly greater mean hospital costs ($29 465 vs $19 245; P < .01) and longer average length of hospital stay (4.0 vs 2.6 days; P < .01) compared with ventral fusion surgery.
CONCLUSION: Surgery for treating CSM was followed by significant improvement in disease-specific symptoms and in HR-QOL. Greater improvement in HR-QOL was observed after ventral surgery. Dorsal fusion surgery was associated with longer length of hospital stay and higher hospital costs. The pilot study demonstrated feasibility for a larger randomized clinical trial.
*Wallace Clinical Trials Center, Greenwich, Connecticut; †Connecticut Spine Institute, Greenwich, Connecticut; ‡Department of Neurosurgery, Yale University School of Medicine, New Haven, Connecticut; §Yale Center for Clinical Investigation, Yale University School of Medicine, New Haven, Connecticut; ∥Dartmouth College, Hanover, New Hampshire; ¶The Center for Spine Health and Department of Neurosurgery, Cleveland Clinic Foundation, Cleveland, Ohio; #Department of Neurosurgery, Lahey Clinic, Burlington, Massachusetts; **Department of Neurosurgery, University of Utah Health Sciences Center, Salt Lake City, Utah; ††Department of Neurosurgery, Danbury Hospital, Danbury, Connecticut; ‡‡Department of Neurosurgery, Massachusetts General Hospital, Boston, Massachusetts; §§Department of Neurosurgery, Mt. Sinai Hospital, New York, New York; ∥∥Section of Neurosurgery, VA Connecticut Healthcare System, West Haven, Connecticut; ¶¶Department of Neurosurgery, University of Medicine and Dentistry of New Jersey–New Jersey Medical School, Newark, New Jersey
Received, February 4, 2010.
Accepted, June 10, 2010.
Correspondence: Zoher Ghogawala, MD, Wallace Clinical Trials Center, Yale University School of Medicine, Greenwich Hospital, 5 Perryridge Road, Greenwich, CT 06830. E-mail firstname.lastname@example.org