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.
METHODS
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.


BACKGROUND
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 degrees 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.
Ghogawala
Zoher
Z
Department of Neurosurgery, Wallace Clinical Trials Center, Yale University School of Medicine, Greenwich Hospital, Greenwich, CT 06830, USA. zoher.ghogawala@yale.edu
Coumans
Jean-Valery
JV
Benzel
Edward C
EC
Stabile
Lauren M
LM
Barker
Fred G
FG
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002574:Cervical Vertebrae / Q000601:surgery; D003625:Data Collection; D019299:Decompression, Surgical / Q000379:methods*; D004608:Eligibility Determination / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D010820:Physicians; D016684:Prone Position; D016032:Randomized Controlled Trials as Topic; D012044:Regression Analysis; D013117:Spinal Cord Compression / Q000601:surgery*; D016683:Supine Position