Fusion or no Fusion After Decompression of the Spinal Cord in Patients With Degenerative Cervical Myelopathy

Background: Degenerative cervical myelopathy (DCM) is characterized by neck pain, neck stiffness, weakness, paresthesia, sphincter disturbance and balance disorder. The mean age for symptoms is 64 years and more men than women, 2.7:1, are affected. The most common level is C5-C6. DCM is the predominant cause of spinal cord dysfunction in the elderly worldwide. Surgical options include stand-alone laminectomy, laminectomy and fusion and laminoplasty. The preferable surgical approach is though, a matter of controversy. The objective of this study is to compare stand-alone laminectomy to laminectomy and fusion. Methods/Design: This is a multicenter randomized, controlled, parallel group non-inferiority trial. A total of 300 adult participants are allocated in a ratio of 1:1. The primary endpoint is reoperation for any reason within 5 years of follow-up. Sample size and power calculations were performed by estimating the reoperation rate after laminectomy to 3.4% and after laminectomy with fusion to 7.9% based on data from the Swedish spine registry (Swespine) on patients with DCM. Secondary outcomes are the patient derived modified Japanese orthopaedic association (P-mJOA) score, Neck disability index (NDI), European quality of life five dimensions (EQ-5D), Numeric rating scale (NRS) for neck and arm pain, Hospital anxiety and depression scale (HADS), development of kyphosis measured as the cervical sagittal vertical axis (cSVA) and, death. Clinical and radiological follow-up is performed at 3, 12, 24 and 60 months after surgery. The main inclusion criteria is 1-4 levels of DCM in the subaxial spine, C3-C7, with or without deformity. The REDcap will be used for safe data management. Data will be analyzed in the per protocol (PP) population, defined as randomized patients who are still alive without having emigrated or left the study after five years. Discussion: This will be the first randomized controlled trial comparing two of the most common surgical treatment