Degenerative cervical spine disease (neck arthritis) represents one of the most common indications for spinal surgery in the United States. Approximately 112,400 operations for cervical arthritis are now performed annually with hospital charges greater than $2 billion per year. Utilization of cervical spine operations has increased 100 percent over the last decade. Recent data from administrative databases clearly demonstrate that surgery for cervical arthritis has many early complications as well as late failures, leading to many re-operations. Advanced cervical arthritis can lead to narrowing (stenosis) of the spinal canal and compression of the spinal cord. This compression coupled with repetitive motion can injure the spinal cord, resulting in gait instability, bladder dysfunction, and difficulty with fine motor movements in the hands, a clinical syndrome known as cervical spondylotic myelopathy (CSM). CSM represents the most common cause of spinal cord injury in the United States. There is a significant need for new clinical trials on surgery for CSM. Surgical decompression for CSM can improve its disabling symptoms. The optimal surgical treatment, however, remains controversial, with disagreement among proponents of three main approaches: ventral decompression and fusion, dorsal decompression and fusion, or dorsal laminoplasty. Because we do not know which operation for CSM is optimal, it is likely that many patients with this disease are not receiving the best treatment. There is a growing consensus among spinal surgeons that a randomized clinical trial (RCT) comparing these three approaches is necessary.
Our objective is to conduct an RCT comparing ventral decompression with fusion versus dorsal decompression with fusion or dorsal laminoplasty for patients with multi-level CSM with the following specific goals:
- To determine whether one type of surgery is associated with better overall quality of life for patients with CSM
- To determine whether different surgical approaches to treating CSM are associated with different out-of-pocket expenses or differences in productivity after surgery
We propose to conduct a multi-center RCT comparing ventral versus dorsal approaches in patients with multi-level CSM. Valid outcomes instruments will be used to assess patients' overall health-related quality of life. In addition, complication rates, re-operation rates, and out-of-pocket expenses will be collected. One hundred fifty-nine randomized patients will be recruited from 10 sites over an accrual period of 1.5 years with one-year minimum follow-up. The overall goal of the study is to define the optimal treatment for CSM. The study’s results will reduce harm from surgery from CSM, optimize patient-oriented health-related quality of life outcome, and provide information about complications and loss of productivity following surgery that will empower patients to make more-informed decisions about their own health care.