医学
随机化
随机对照试验
外科
致盲
骨科手术
椎管狭窄
畸形
减压
后凸
椎管
射线照相术
脊髓
精神科
作者
Zoher Ghogawala,Jean-Valéry Coumans,Edward C. Benzel,Lauren Stabile,Fred G. Barker
出处
期刊:Spine
[Ovid Technologies (Wolters Kluwer)]
日期:2007-02-01
卷期号:32 (4): 429-436
被引量:55
标识
DOI:10.1097/01.brs.0000255068.94058.8a
摘要
In Brief 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.
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