Cervical Spondylotic Myelopathy - Cost Observational Surgical Trial (CSM-COST)

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).

1. To determine if laminoplasty is more cost-effective compared to dorsal fusion or ventral fusion surgery.
2. To determine the relative cost-effectiveness between anterior cervical discectomy and fusion (ACDF), posterior instrumented cervical fusion (PCF), and cervical laminoplasty.

Study Overview

• Status: Completed
• Conditions: Cervical Spondylosis With Myelopathy
• Intervention / Treatment: Procedure: ACDF; Procedure: Posterior Cervical Fusion; Procedure: Cervical Laminoplasty

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 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.

• For professional services (identified with either HCPCS code or CPT-4 codes) provided to patients during the index hospitalization, costs will be calculated using national reimbursement amounts from the appropriate Medicare fee schedules for the respective year. - Assumptions: Detailed line-item services of all HCPCS codes and CPT-4 codes (including any necessary billing modifiers) will be provided for all professional services. Data will be complete for all patients from all sites.

II. One-year All-Cause Cost - performed on patients from sites capturing 1 year utilization:

• One-year all-cause costs will be calculated on hospital and professional services in the manner described above. - Assumptions: The same underlying assumptions described above.

III. Time to Return to Work - performed on all patients reporting employment:

• Investigators will assume that the work halted for patients on the procedure date).
• For patients to whom this outcome applies, the investigators will compare different cohorts using return to work as a time-to-event outcome.
• Lost wages will be estimated using the median weekly earnings in the US as reported by the Bureau of Labor Statistics.
• Patients providing no employment information will be assumed to have zero lost wages.
• Job-specific wages will not be estimated.

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.

• Study Type: Observational
• Enrollment (Actual): 269

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Burlington, Massachusetts, United States, 01803
      • Lahey Hospital & Medical Center
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

-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:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anterior Cervical Discectomy and Fusion; 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
Posterior Instrumented Cervical Fusion; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Health Costs - Societal Perspective	Index hospitalization costs+one-year all cause costs+loss of productivity costs	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Index Hospitalization Costs	Hospital Costs	30 days
1-Year all-cause health costs	All health costs over 1 year	1 year
Loss of productivity costs	Costs associated with loss of productivity from a societal perspective	5 years

Collaborators and Investigators

• Sponsor: Lahey Clinic
• Collaborators: Mayo Clinic
• Investigators: Study Director: Zoher Ghogawala, MD, Lahey Hospital & Medical Center; Principal Investigator: Robert G. Whitmore, MD, Lahey Hospital & Medical Center

Publications and helpful links

General Publications

• Ghogawala Z, Terrin N, Dunbar MR, Breeze JL, Freund KM, Kanter AS, Mummaneni PV, Bisson EF, Barker FG 2nd, Schwartz JS, Harrop JS, Magge SN, Heary RF, Fehlings MG, Albert TJ, Arnold PM, Riew KD, Steinmetz MP, Wang MC, Whitmore RG, Heller JG, Benzel EC. Effect of Ventral vs Dorsal Spinal Surgery on Patient-Reported Physical Functioning in Patients With Cervical Spondylotic Myelopathy: A Randomized Clinical Trial. JAMA. 2021 Mar 9;325(10):942-951. doi: 10.1001/jama.2021.1233.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): March 30, 2018
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: August 11, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: cost-effectiveness; spinal fusion; cervical spondylotic myelopathy; laminoplasty; health resource utilization
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Hematologic Diseases; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Cord Diseases; Bone Marrow Diseases; Spondylosis
• Other Study ID Numbers: LCID: 2023; CE-1304-6173 (Other Identifier: Patient-Centered Outcomes Research Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data from the CSM-S trial including cost data will be available to other researchers who provide a valid study protocol.
• IPD Sharing Time Frame: Within 6 months of primary publication of the data and for 5 years thereafter
• IPD Sharing Access Criteria: Researchers with a clear and valid research protocol will be able to gain access to the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No