Cervical Spondylotic Myelopathy Surgical Trial (CSM-S Trial)
ID Number 13-1942Principal Investigator(s)
Department(s) or Division(s)
The purpose of the study is to determine the best surgical approach for subjects who have spinal cord problems (myelopathy) caused by pressure (compression) from degenerative changes in the neck's spinal column. Patients with the spinal condition cervical spondylotic myelopathy (CSM) will be included in the study. Spinal surgeons in the United States have not reached an agreement about which type of surgery (decompression/fusion from the front or decompression with fusion or laminoplasty from the back) is best for the condition. All three surgical procedures are accepted and none are considered investigational. Mount Sinai Hospital is one of many centers in the United States participating in this study. Patients that have been identified for cervical spine surgery in routine practice will be enrolled in the study and will discuss a treatment strategy that may be selected by a process of chance called randomization. In order to educate both patient and spinal surgeon the patient's images will be transmitted electronically via a web-based network (with all identifying information removed) to the other 15 CSM investigators for expert opinion. Surgeon investigators will indicate either a) randomize or b) do not randomize (if one strategy is strongly favored over the other). The patient will see the results of the expert panel's review. If the majority favors randomization this will be offered. Otherwise the optimal strategy will be reached by discussion between the patient and spinal surgeon based on the expert opinions and the patient will be entered into the trial without randomization. About 91 non-randomized subjects will be entered into the study nationwide over 1 year. About 159 randomized subjects will be entered into the study nationwide over 1 year. After the surgical procedure the patient will be treated in a standard fashion. In addition patients will be contacted to complete various questionnaires before surgery 3 months after surgery 6 months after surgery and annually one through five years after surgery. MRI will be done pre-op and three months after surgery. A CT scan will be performed within 24 h after surgery. X-rays will be done pre-op and one year after surgery. An independent radiologist will review the films. The study sponsor is the Patient-Centered Outcomes Research Institute (PCORI).
Recruiting Patients: No