Cervical Spondylotic Myelopathy Surgical Trial: Randomized, Controlled Trial Design and Rationale

BACKGROUND:Cervical spondylotic myelopathy (CSM) is the most common cause of spinal cord dysfunction in the world. There are significant practice variation and uncertainty as to the optimal surgical approach for treating CSM. OBJECTIVE:To determine whether ventral surgery is associated with superior Short Form-36 Physical Component Summary outcome at the 1-year follow-up compared with dorsal (laminectomy/fusion or laminoplasty) surgery for the treatment of CSM, to investigate whether postoperative sagittal balance is an independent predictor of overall outcome, and to compare health resource use for ventral and dorsal procedures. METHODS:The study is a randomized, controlled trial with a nonrandomized arm for patients who are eligible but decline randomization. Two hundred fifty patients (159 randomized) with CSM from 11 sites will be recruited over 18 months. The primary outcome is the Short Form-36 Physical Component Summary score. Secondary outcomes include disease-specific outcomes, overall health-related quality of life (EuroQOL 5-dimension questionnaire), and health resource use. EXPECTED OUTCOMES:This will be the first randomized, controlled trial to compare directly the health-related quality-of-life outcomes for ventral vs dorsal surgery for treating CSM. DISCUSSION:A National Institutes of Health-funded (1R13AR065834-01) investigator meeting was held before the initiation of the trial to bring multiple stakeholders together to finalize the study protocol. Study investigators, coordinators, and major stakeholders were able to attend and discuss strengths of, limitations of, and concerns about the study. The final protocol was approved for funding by the Patient-Centered Outcomes Research Institute (CE-1304-6173). The trial began enrollment on April 1, 2014. ABBREVIATIONS:CSM, cervical spondylotic myelopathyCSM-S, Cervical Spondylotic Myelopathy-SurgicalEQ-5D, EuroQOL 5-dimension questionnaireHIPAA, Health Insurance Portability and Accountability ActIRB, Institutional Review BoardNDI, Neck Disability IndexNIH, National Institutes of HealthPCORI, Patient-Centered Outcomes Research InstitutePCS, Physical Component SummaryPI, principal investigatorQOL, quality of lifeRCT, randomized clinical trialSF-36, Short Form-36