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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

Ghogawala, Zoher, MD; Coumans, Jean-Valery, MD; Benzel, Edward C., MD; Stabile, Lauren M., BS; Barker, Fred G. II, MD

doi: 10.1097/01.brs.0000255068.94058.8a
Cervical Spine
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Study Design. Surgeons attending a Cervical Spine Research 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 versus 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 prepared. Surgeons supplied demographic information, preferred 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% recommended 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 stenosis as additional exclusion criteria, 12 of 20 survey cases were considered potentially eligible for randomization. Orthopedic and neurologic surgeons were similar in determining 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.

Ninety-one spine surgeons completed a survey of 20 cases of cervical spondylotic myelopathy (CSM). Five simple exclusion criteria for a prospective RCT comparing ventral and dorsal approaches were identified. Over 50% of CSM cases from routine practice would potentially be eligible for a randomized controlled trial.

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

© 2007 Lippincott Williams & Wilkins, Inc.