Cervical Spondylotic Myelopathy Surgical Trial (CSM-S Trial)
|Principal Investigator: Erica Bisson|
|Keywords: Cervical , Spondylotic Myelopathy , Kyphosis , Decompression , Neck , Spinal Cord||Department: Neurosurgery - Adult|
|IRB Number: 00069689||Co Investigator: AndrewDailey|
|Specialty: Neurosurgery, Neurosurgery|
|Sub Specialties: Spine Surgery, Neuro Spine Surgery|
1a. To determine if ventral surgery is associated with superior SF-36 PCS (quality of life) outcome at one year follow-up compared to dorsal (fusion or laminoplasty) surgery.
1b. To determine if, compared to pre-operative baseline status, both ventral and dorsal surgery for CSM improve symptoms of spinal cord dysfunction using mJOA (self assessed functional measure scale).
2. To determine if, from a patient perspective, health resource utilization (out-of-pocket expenses and loss of productivity) for ventral surgery, dorsal fusion, and laminoplasty surgery are different.
3. To determine if cervical sagittal balance post-operatively is a significant predictor of SF-36 PCS (quality of life) outcome.
Surgical decompression for CSM can improve its disabling symptoms, but surgical complications are common and many of these complications affect patients’ overall health-related quality of life. The optimal surgical treatment, therefore, remains controversial, with disagreement between three main approaches: ventral decompression and fusion, dorsal decompression and fusion, or dorsal laminoplasty. This study aims to test the hypothesis that ventral surgery is associated with superior SF-36 PCS outcome at one year follow-up compared to dorsal approaches and that both ventral and dorsal surgery improve symptoms of spinal cord dysfunction using the mJOA score. A secondary hypothesis is that health resource utilization for ventral surgery, dorsal fusion, and laminoplasty surgery are different. A third hypothesis is that cervical sagittal balance post-operatively is a significant predictor of SF-36 PCS outcome.
Patients aged 45-80 years with CSM (≥2 levels of spinal cord compression from C3 to C7) presenting with ≥2 of the following symptoms/signs: clumsy hands, gait disturbance, hyperreflexia, up going toes, bladder dysfunction, or ankle clonus
Any of the following: C2-C7 kyphosis>5º (measured in extension), segmental kyphotic deformity (defined by ≥3 osteophytes extending dorsal to a C2-C7 dorsal-caudal line measured on cervical spine CT), ossification of posterior longitudinal ligament (OPLL – measured on cervical spine CT), developmental narrow canal (12 mm anterior-posterior canal diameter at the base of C2 measured on cervical spine radiograph), previous cervical spine surgery, or significant active health-related co-morbidity (Anesthesia Class III or higher).