Clinical trial NCT05994404: Cervical Spondylotic Myelopathy - Cost Observational Surgical Trial
Official title: Cervical Spondylotic Myelopathy - Cost Observational Surgical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Spondylosis With Myelopathy
Keywords: cost-effectiveness
cervical spondylotic myelopathy
health resource utilization
spinal fusion
laminoplasty
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2023-08-16
Enrollment: 269
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 (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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Total Health Costs - Societal Perspective
timeFrame: 5 years
Secondary outcomes:
measure: Index Hospitalization Costs
timeFrame: 30 days
measure: 1-Year all-cause health costs
timeFrame: 1 year
measure: Loss of productivity costs
timeFrame: 5 years
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Lahey Hospital & Medical Center
name: Zoher Ghogawala, MD
role: STUDY_DIRECTOR
affiliation: Lahey Hospital & Medical Center
name: Robert G. Whitmore, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.