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CompletedNCT05994404CSM-COSTUpdated Aug 16, 2023

Cervical Spondylotic Myelopathy - Cost Observational Surgical Trial

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
269
Ages
45 Years to 80 Years
Sex
All
01

Study 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 (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.
Read the 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.

02

Conditions studied

  • Cervical Spondylosis With Myelopathy

Keywords

  • cost-effectiveness
  • cervical spondylotic myelopathy
  • health resource utilization
  • spinal fusion
  • laminoplasty
03

In context

Spondylosis

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
All
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.

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

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
269 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • ProcedureACDF
  • ProcedurePosterior Cervical Fusion
  • ProcedureCervical Laminoplasty
06

What researchers measure

Primary outcomes

  1. Total Health Costs - Societal Perspective

    Index hospitalization costs+one-year all cause costs+loss of productivity costs

    Time frame: 5 years

Secondary outcomes

  1. Index Hospitalization Costs

    Hospital Costs

    Time frame: 30 days

  2. 1-Year all-cause health costs

    All health costs over 1 year

    Time frame: 1 year

  3. Loss of productivity costs

    Costs associated with loss of productivity from a societal perspective

    Time frame: 5 years

07

Study locations

2 sites
  • Lahey Hospital & Medical Center
    Burlington, Massachusetts 01803, United States
  • Mayo Clinic
    Rochester, Minnesota 55902, United States
08

References and documents

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. PubMed 33687463 ↗

Study documents

  • Study protocol · Jul 10, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

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

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05994404
Lead sponsor
Lahey Clinic
Collaborators
Mayo Clinic
Responsible party
Sponsor
First posted
Aug 16, 2023
Start date
Apr 1, 2014
Primary completion
Mar 30, 2018
Completion
Apr 1, 2019
Last update
Aug 16, 2023

Study contacts

Zoher Ghogawala, MD
study director · Lahey Hospital & Medical Center
Robert G. Whitmore, MD
principal investigator · Lahey Hospital & Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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