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.
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
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).
- To determine if laminoplasty is more cost-effective compared to dorsal fusion or ventral fusion surgery.
- 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.
- 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:
- 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.
- Conditions
- Cervical Spondylosis With Myelopathy
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Cervical Laminoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Health Costs - Societal Perspective
Index hospitalization costs+one-year all cause costs+loss of productivity costs
Measured: 5 years
Secondary outcomes (3)
Index Hospitalization Costs
Hospital Costs
Measured: 30 days
1-Year all-cause health costs
All health costs over 1 year
Measured: 1 year
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.
- First posted16 Aug 2023
- Study start1 Apr 2014
- Primary completion30 Mar 2018
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Spondylosis With MyelopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Zoher Ghogawala, MD, Study director, Lahey Hospital & Medical CenterRobert G. Whitmore, MD, Principal investigator, Lahey Hospital & Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Spondylotic Myelopathy - Cost Observational Surgical Trial
- ClinicalTrials.gov ID
- NCT05994404
- Acronym / sponsor ID
- CSM-COST / LCID: 2023
- Conditions
- Cervical Spondylosis With Myelopathy
- Keywords
- cost-effectiveness, cervical spondylotic myelopathy, health resource utilization, spinal fusion, laminoplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- To determine if laminoplasty is more cost-effective compared to dorsal fusion or ventral fusion surgery.
- 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.
- 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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anterior Cervical Discectomy and Fusion | – | Procedure: ACDFVentral 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. |
| Posterior Instrumented Cervical Fusion | – | Procedure: Posterior 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. |
| Laminoplasty | – | Procedure: Cervical 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. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- -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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACDF | Procedure or surgery | Anterior Cervical Discectomy and Fusion |
| Posterior Cervical Fusion | Procedure or surgery | Posterior Instrumented Cervical Fusion |
| Cervical Laminoplasty | Procedure or surgery | Laminoplasty |
Primary outcome
Total Health Costs - Societal Perspective
Time frame: 5 years
Index hospitalization costs+one-year all cause costs+loss of productivity costs
3 secondary outcomes
Index Hospitalization Costs
Time frame: 30 days
1-Year all-cause health costs
Time frame: 1 year
Loss of productivity costs
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Results publication: PubMed 33687463Ghogawala 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.
- Individual participant dataSharing planned: Yes. De-identified data from the CSM-S trial including cost data will be available to other researchers who provide a valid study protocol.
Related trials for Cervical Spondylosis With Myelopathy
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Not yet recruitingObservational study
A Multicenter Registry-Based Study Across the Spectrum of Degenerative Cervical Myelopathy
Degenerative Cervical Myelopathy, Non-myelopathic Degenerative Cervical Cord Compression
Active, not recruiting
Multi-centre Study to Evaluate ACAF Versus Laminoplasty in Treating Cervical Ossification of the Posterior Longitudinal Ligament
Ossification of Posterior Longitudinal Ligament, Cervical Spondylosis With Myelopathy
Active, not recruiting
Cervical Spondylotic Myelopathy Surgical Trial
Cervical Spondylosis With Myelopathy
RecruitingObservational study
Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty
Cervical Spondylosis With Myelopathy, Cervical Radiculopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zoher Ghogawala, MD study director
Lahey Hospital & Medical Center
Robert G. Whitmore, MD principal investigator
Lahey Hospital & Medical Center
2 sites in 1 country: see every site and its status.
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.