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 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.
RCT Entities:
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 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.
Authors: Zoher Ghogawala; Norma Terrin; Melissa R Dunbar; Janis L Breeze; Karen M Freund; Adam S Kanter; Praveen V Mummaneni; Erica F Bisson; Fred G Barker; J Sanford Schwartz; James S Harrop; Subu N Magge; Robert F Heary; Michael G Fehlings; Todd J Albert; Paul M Arnold; K Daniel Riew; Michael P Steinmetz; Marjorie C Wang; Robert G Whitmore; John G Heller; Edward C Benzel Journal: JAMA Date: 2021-03-09 Impact factor: 56.272
Authors: Stavros G Memtsoudis; Alexander Hughes; Yan Ma; Ya Lin Chiu; Andrew A Sama; Federico P Girardi Journal: Clin Orthop Relat Res Date: 2011-03 Impact factor: 4.176
Authors: Zoher Ghogawala; Edward C Benzel; Robert F Heary; K Daniel Riew; Todd J Albert; William E Butler; Fred G Barker; John G Heller; Paul C McCormick; Robert G Whitmore; Karen M Freund; J Sanford Schwartz Journal: Neurosurgery Date: 2014-10 Impact factor: 4.654
Authors: Adam M Sonabend; Brad E Zacharia; Michael B Cloney; Aarón Sonabend; Christopher Showers; Victoria Ebiana; Matthew Nazarian; Kristin R Swanson; Anne Baldock; Henry Brem; Jeffrey N Bruce; William Butler; Daniel P Cahill; Bob Carter; Daniel A Orringer; David W Roberts; Oren Sagher; Nader Sanai; Theodore H Schwartz; Daniel L Silbergeld; Michael B Sisti; Reid C Thompson; Allen E Waziri; Zoher Ghogawala; Guy McKhann Journal: Neurosurgery Date: 2017-04-01 Impact factor: 4.654