Status:
COMPLETED
Cervical Spondylotic Myelopathy - Cost Observational Surgical Trial
Lead Sponsor:
Lahey Clinic
Collaborating Sponsors:
Mayo Clinic
Conditions:
Cervical Spondylosis With Myelopathy
Eligibility:
All Genders
45-80 years
Brief Summary
The purpose of the study is to determine the cost-effectiveness of different surgical strategies to treat cervical spondylotic myelopathy. The study will use data generated from the CSM-S Trial (NCT02...
Detailed Description
In this study, the investigators aim to cover a significant gap in the literature, namely, to compare anterior and posterior surgical approaches for the management of CSM on the cost of care. The inve...
Eligibility Criteria
Inclusion
- Patients with Cervical Myelopathy (\> or equal to 2 levels of spinal cord compression from C3 to C7) with 2 or more of the following symptoms/ signs: clumsy hands, gait disturbance, hyperreflexia, upgoing toes, bladder dysfunction.
Exclusion
- C2-C7 kyphosis\>5 degrees (measured in standing extension radiograph)
- segmental kyphotic deformity (defined by greater than 3 osteophytes extending dorsal to a C2-C7 dorsal-caudal line measured on cervical spine CT)
- structurally significant ossification of the posterior longitudinal ligament (OPLL - measured on cervical spine CT)
- previous cervical spine surgery, or significant active health-related co-morbidity (Anesthesia Class IV or higher)
Key Trial Info
Start Date :
April 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2019
Estimated Enrollment :
269 Patients enrolled
Trial Details
Trial ID
NCT05994404
Start Date
April 1 2014
End Date
April 1 2019
Last Update
August 16 2023
Active Locations (2)
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1
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States, 01803
2
Mayo Clinic
Rochester, Minnesota, United States, 55902