An observational study in Cervical Spondylosis With Myelopathy, sponsored by Lahey Clinic. Completed at 2 sites in United States. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-16.
Sponsored by Lahey Clinic · Observational
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 (NCT02076113).
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 investigators will conduct a post-hoc analysis of data from the randomized trial "Cervical Spondylotic Myelopathy Surgical Trial" (www.ClinicalTrials.gov; identifier: NCT02076113). This trial was conducted in collaboration between multiple academic institutions in North America. The results of the CSM-S RCT in terms of clinical and patient-reported outcomes suggested similar effectiveness with anterior and posterior surgical approaches. Notably, the study showed that cervical laminoplasty, a relatively low instrumentation-related cost procedure, was effective in managing CSM. The findings of the analysis proposed herein will add a new dimension to clinical decision-making by informing patient selection and improving the quality of care.
Post-hoc analysis will be conducted on the following data that were collected during the trial.
I. Functional outcomes determined by well-known quantitative scales (SF-36, Oswestry Neck, mJOA, and EuroQol-5D) at pre-op, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years.
II. Health resource utilization information was collected using patient diaries along with copies of all medical bills and receipts at 1 month, 3 months, 6 months, and 12 months post-operatively for all patients. Participants were asked to monitor days missed from work and days unable to perform usual activities, in addition to days missed from work for medical treatments or evaluations.
The overall cost will be estimated for each patient from a societal perspective and will include the following components:
I. Index Hospitalization Cost - performed on all patients:
Hospital Costs: Total hospital charges (TotalHC) will be used to estimate costs using hospital-specific and year-specific Medicare cost-to-charge ratios (CCR). The costs will be adjusted for inflation to the latest year of the study (2018) without a 3% discount. - Assumptions: cost-to-charge ratios for all hospitals and all relevant years will be provided. Data will be complete for all patients from all sites.
o As a sub-analysis, hospital charges for specific revenue centers (i.e., radiology, pharmacy, physiotherapy, and occupational therapy) will be converted to costs using hospital-specific and year-specific CCRs. This will allow the identification of the major drivers of the difference in cost between the surgical strategies. A crosswalk between the revenue center and the cost center will have to be created. - Assumptions: Total hospital charges will be segmented out into the relevant revenue centers. All patients will have charges segmented in this manner. No major differences in how total hospital charges will be segmented by each site will exist.
II. One-year All-Cause Cost - performed on patients from sites capturing 1 year utilization:
III. Time to Return to Work - performed on all patients reporting employment:
Index hospitalization costs and one-year all-cause costs will be combined with costs due to loss of productivity (indirect costs) to estimate total costs for each patient from a societal perspective. This will be performed on the subpopulation for which one-year costs were captured.
144 studies on the registry are indexed under Spondylosis; 41 are open to participants now.
This study's enrollment of 269 is above the median of 100 across 40 observational studies indexed under Spondylosis.
Browse Spondylosis studies →Lahey Clinic is the lead sponsor of 58 studies on the registry; 4 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Study population consists of patients with multi-level cervical spondylotic myelopathy without kyphosis and who satisfied clinical equipoise criteria (ventral vs. dorsal approach) as judged by a panel of at least 15 spine experts.
-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 Criteria:
Ventral decompression and fusion was performed using multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft was used at each disc space and all compressive osteophytes were removed using the operating microscope. Plate fixation was done with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications.
Procedure: ACDF
Dorsal decompression and instrumented fusion was performed using midline cervical laminoectom with the application of lateral mass screws and rods for rigid fixation. Local bone was used along with allograft to promote a lateral mass fusion.
Procedure: Posterior Cervical Fusion
Laminoplasty was performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) were used with titanium plates and screws to expand the spinal canal diameter.
Procedure: Cervical Laminoplasty
Total Health Costs - Societal Perspective
Index hospitalization costs+one-year all cause costs+loss of productivity costs
Time frame: 5 years
Index Hospitalization Costs
Hospital Costs
Time frame: 30 days
1-Year all-cause health costs
All health costs over 1 year
Time frame: 1 year
Loss of productivity costs
Costs associated with loss of productivity from a societal perspective
Time frame: 5 years
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified data from the CSM-S trial including cost data will be available to other researchers who provide a valid study protocol.
Supporting information: Study protocol, Sap
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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