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Cervical Spondylosis With MyelopathyCSM-COSTNCT05994404

Cervical Spondylotic Myelopathy - Cost Observational Surgical Trial

An observational study of Cervical Spondylosis With Myelopathy, run by Lahey Clinic at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 80 years
Conditions the study is for
Cervical Spondylosis With Myelopathy
What is being tested?
ACDF, Posterior Cervical Fusion and Cervical Laminoplasty
Type of treatment
Surgery or procedure
How many people
269 participants
Where
2 sitesUnited States
Study dates
1 Apr 2014to 1 Apr 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • -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.

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01803

  • Mayo Clinic

    Rochester, Minnesota, 55902

Other trials in United States

About this study

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.

  1. 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:

  1. 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.
  • 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.

Being tested
ACDF, Posterior Cervical Fusion, Cervical Laminoplasty
Keywords
cost-effectiveness, cervical spondylotic myelopathy, health resource utilization, spinal fusion, laminoplasty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACDFProcedure or surgery

  • Posterior Cervical FusionProcedure or surgery

  • Cervical LaminoplastyProcedure or surgery

Study groups in NCT05994404
Study groupRoleWhat they receive
Anterior Cervical Discectomy and FusionVentral 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.
Receives: Procedure: ACDF
Posterior Instrumented Cervical FusionDorsal 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.
Receives: Procedure: Posterior Cervical Fusion
LaminoplastyLaminoplasty 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.
Receives: Procedure: Cervical Laminoplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Health Costs - Societal Perspective

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

    Measured: 5 years

Secondary outcomes (3)
  1. Index Hospitalization Costs

    Hospital Costs

    Measured: 30 days

  2. 1-Year all-cause health costs

    All health costs over 1 year

    Measured: 1 year

  3. Loss of productivity costs

    Costs associated with loss of productivity from a societal perspective

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2023
  2. Study start1 Apr 2014
  3. Primary completion30 Mar 2018
  4. Study completion1 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
269 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05994404
Sponsor's protocol ID
LCID: 2023
Other IDs
CE-1304-6173
Acronym
CSM-COST
Status last verified
Jul 2023
First submitted
28 Jul 2023
Last updated
16 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data from the CSM-S trial including cost data will be available to other researchers who provide a valid study protocol.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Spondylosis With Myelopathy, run by Lahey Clinic at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Health Costs - Societal Perspective (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05994404, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.

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