SPINE Volume 32, Number 4, pp 429 – 436 ©2007, Lippincott Williams & Wilkins, Inc. Ventral Versus Dorsal Decompression for Cervical Spondylotic Myelopathy: Surgeons’ Assessment of Eligibility for Randomization in a Proposed Randomized Controlled Trial Results of a Survey of the Cervical Spine Research Society Zoher Ghogawala, MD, Jean-Valery Coumans, MD, Edward C. Benzel, MD, Lauren M. Stabile, BS, and Fred G. Barker, II, MD Study Design. Surgeons attending a Cervical Spine Re- search Society (CSRS) meeting were surveyed about the surgical approach to cervical spondylotic myelopathy (CSM). Objective. To elicit spine surgeons’ opinions on the suitability of a panel of test cases for randomization in a proposed randomized controlled trial (RCT) of ventral ver- sus dorsal decompression for CSM. Summary of Background Data. The optimal surgical decompression strategy for CSM has not been defined. Specific eligibility criteria should be defined before a RCT is initiated. Methods. Twenty actual cases with images were pre- pared. Surgeons supplied demographic information, pre- ferred surgical approach, and eligibility for randomization for 10 cases. Results. A total of 91 of 239 (38%) surgeons completed the survey. Of 900 case-strategy responses, 51% recom- mended ventral surgery, 38% dorsal surgery, and 11% a combined approach. Both overall C2–C7 kyphosis 5° and a segmental kyphotic deformity were inversely correlated with eligibility for randomization (P  0.001 for both). Using these 2 criteria plus age over 85 years, ossification of the posterior longitudinal ligament, and congenital canal steno- sis as additional exclusion criteria, 12 of 20 survey cases were considered potentially eligible for randomization. Or- thopedic and neurologic surgeons were similar in determin- ing a case’s eligibility for randomization. Conclusions. These results measure surgeons’ opinions on the suitability of cases for randomization and help to define entry and exclusion criteria for a RCT comparing ventral to dorsal strategies. Over 50% of CSM cases from a general spinal practice might be eligible for randomization. Key words: survey, cervical spondylotic myelopathy, clinical trial design. Spine 2007;32:429 – 436 Cervical spondylotic myelopathy (CSM) is a common cause of neurologic morbidity, potentially resulting in a substantial decrease in quality of life as assessed by well- established health outcome instruments. 1 While many authors have advocated surgical decompression for CSM, the optimal surgical strategy remains controver- sial, and a variety of both ventral and dorsal approaches have been advocated. 2–4 It is estimated that 30% of pa- tients have an unsatisfactory outcome after surgery for CSM. 5 Furthermore, the well-known surgical complica- tion rate in multilevel cases underscores the importance of optimizing the operative approach for each patient. 6 The prevalence of this disease in the elderly, who might be more susceptible to complications, emphasizes the im- portance of identifying the optimal surgical approach. There are no established guidelines for the manage- ment of patients with CSM. Published series contain het- erogeneous patient populations, various approaches, and the reported outcomes differ, rendering comparisons difficult. 7 The current controversy over the best surgical approach to CSM (ventral vs. dorsal) indicates the need for a well-conducted prospective randomized trial. This has been advocated by several authors, implying that participation in a multicenter trial would be of interest to spinal surgeons. 8 While many clinical variables have been studied in relation to surgical approach and out- come, these factors have not been prospectively analyzed using established outcomes instruments. This has created significant controversy, even among experts, as to the optimal approach. One crucial item in the design of a randomized con- trolled trial (RCT) in surgery is to define clearly the cir- cumstances on which clinical uncertainty (equipoise) ex- ists between two or more interventions. Clinical equipoise was defined by Freedman as “genuine uncer- tainty within the expert medical community” about the optimal treatment for a specific condition. 9 The first step toward defining clinical equipoise for a randomized study for CSM is to determine which types of cases are controversial among spinal surgeons with an expertise in the cervical spine. In order to define which cases might be appropriate for randomization, we designed a scientific survey which was administered to surgeons attending the Cervical Spine Research Society (CSRS) annual meeting in December 2004. The objective of the survey was to From the Department of Neurosurgery, Wallace Clinical Trials Center, Yale University School of Medicine, Greenwich Hospital, Greenwich, CT. Acknowledgment date: October 28, 2005. First revision date: January 19, 2006. Second revision date: March 11, 2006. Third revision date: April 14, 2006. Acceptance date: June 5, 2006. Supported by Greenwich Hospital Spine Fund No. 384 (to Z.G.). The manuscript submitted does not contain information about medical device(s)/drug(s). Foundation funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript. Address correspondence and reprint requests to Zoher Ghogawala, MD, Department of Neurosurgery, Wallace Clinical Trials Center, Yale University School of Medicine, Greenwich Hospital, Greenwich, CT 06830; E-mail: zoher.ghogawala@yale.edu 429