xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05994404</url>
    </required_header>
    <id_info>
      <org_study_id>LCID: 2023</org_study_id>
      <secondary_id>CE-1304-6173</secondary_id>
      <nct_id>NCT05994404</nct_id>
    </id_info>
    <brief_title>Cervical Spondylotic Myelopathy - Cost Observational Surgical Trial</brief_title>
    <acronym>CSM-COST</acronym>
    <official_title>Cervical Spondylotic Myelopathy - Cost Observational Surgical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lahey Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Lahey Clinic</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of the study is to determine the cost-effectiveness of different surgical&#xD;
        strategies to treat cervical spondylotic myelopathy. The study will use data generated from&#xD;
        the CSM-S Trial (NCT02076113).&#xD;
  &#xD;
          1. To determine if laminoplasty is more cost-effective compared to dorsal fusion or ventral&#xD;
             fusion surgery.&#xD;
  &#xD;
          2. To determine the relative cost-effectiveness between anterior cervical discectomy and&#xD;
             fusion (ACDF), posterior instrumented cervical fusion (PCF), and cervical laminoplasty.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, the investigators aim to cover a significant gap in the literature, namely, to&#xD;
        compare anterior and posterior surgical approaches for the management of CSM on the cost of&#xD;
        care. The investigators will conduct a post-hoc analysis of data from the randomized trial&#xD;
        &quot;Cervical Spondylotic Myelopathy Surgical Trial&quot; (www.ClinicalTrials.gov; identifier:&#xD;
        NCT02076113). This trial was conducted in collaboration between multiple academic&#xD;
        institutions in North America. The results of the CSM-S RCT in terms of clinical and&#xD;
        patient-reported outcomes suggested similar effectiveness with anterior and posterior&#xD;
        surgical approaches. Notably, the study showed that cervical laminoplasty, a relatively low&#xD;
        instrumentation-related cost procedure, was effective in managing CSM. The findings of the&#xD;
        analysis proposed herein will add a new dimension to clinical decision-making by informing&#xD;
        patient selection and improving the quality of care.&#xD;
  &#xD;
        Post-hoc analysis will be conducted on the following data that were collected during the&#xD;
        trial.&#xD;
  &#xD;
        I. Functional outcomes determined by well-known quantitative scales (SF-36, Oswestry Neck,&#xD;
        mJOA, and EuroQol-5D) at pre-op, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5&#xD;
        years.&#xD;
  &#xD;
        II. Health resource utilization information was collected using patient diaries along with&#xD;
        copies of all medical bills and receipts at 1 month, 3 months, 6 months, and 12 months&#xD;
        post-operatively for all patients. Participants were asked to monitor days missed from work&#xD;
        and days unable to perform usual activities, in addition to days missed from work for medical&#xD;
        treatments or evaluations.&#xD;
  &#xD;
        The overall cost will be estimated for each patient from a societal perspective and will&#xD;
        include the following components:&#xD;
  &#xD;
        I. Index Hospitalization Cost - performed on all patients:&#xD;
  &#xD;
          -  Hospital Costs: Total hospital charges (TotalHC) will be used to estimate costs using&#xD;
             hospital-specific and year-specific Medicare cost-to-charge ratios (CCR). The costs will&#xD;
             be adjusted for inflation to the latest year of the study (2018) without a 3% discount.&#xD;
             - Assumptions: cost-to-charge ratios for all hospitals and all relevant years will be&#xD;
             provided. Data will be complete for all patients from all sites.&#xD;
  &#xD;
             o As a sub-analysis, hospital charges for specific revenue centers (i.e., radiology,&#xD;
             pharmacy, physiotherapy, and occupational therapy) will be converted to costs using&#xD;
             hospital-specific and year-specific CCRs. This will allow the identification of the&#xD;
             major drivers of the difference in cost between the surgical strategies. A crosswalk&#xD;
             between the revenue center and the cost center will have to be created. - Assumptions:&#xD;
             Total hospital charges will be segmented out into the relevant revenue centers. All&#xD;
             patients will have charges segmented in this manner. No major differences in how total&#xD;
             hospital charges will be segmented by each site will exist.&#xD;
  &#xD;
          -  For professional services (identified with either HCPCS code or CPT-4 codes) provided to&#xD;
             patients during the index hospitalization, costs will be calculated using national&#xD;
             reimbursement amounts from the appropriate Medicare fee schedules for the respective&#xD;
             year. - Assumptions: Detailed line-item services of all HCPCS codes and CPT-4 codes&#xD;
             (including any necessary billing modifiers) will be provided for all professional&#xD;
             services. Data will be complete for all patients from all sites.&#xD;
  &#xD;
        II. One-year All-Cause Cost - performed on patients from sites capturing 1 year utilization:&#xD;
  &#xD;
        • One-year all-cause costs will be calculated on hospital and professional services in the&#xD;
        manner described above. - Assumptions: The same underlying assumptions described above.&#xD;
  &#xD;
        III. Time to Return to Work - performed on all patients reporting employment:&#xD;
  &#xD;
          -  Investigators will assume that the work halted for patients on the procedure date).&#xD;
  &#xD;
          -  For patients to whom this outcome applies, the investigators will compare different&#xD;
             cohorts using return to work as a time-to-event outcome.&#xD;
  &#xD;
          -  Lost wages will be estimated using the median weekly earnings in the US as reported by&#xD;
             the Bureau of Labor Statistics.&#xD;
  &#xD;
          -  Patients providing no employment information will be assumed to have zero lost wages.&#xD;
  &#xD;
          -  Job-specific wages will not be estimated.&#xD;
  &#xD;
        Index hospitalization costs and one-year all-cause costs will be combined with costs due to&#xD;
        loss of productivity (indirect costs) to estimate total costs for each patient from a&#xD;
        societal perspective. This will be performed on the subpopulation for which one-year costs&#xD;
        were captured.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 1, 2014</start_date>
    <completion_date type="Actual">April 1, 2019</completion_date>
    <primary_completion_date type="Actual">March 30, 2018</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Total Health Costs - Societal Perspective</measure>
      <time_frame>5 years</time_frame>
      <description>Index hospitalization costs+one-year all cause costs+loss of productivity costs</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Index Hospitalization Costs</measure>
      <time_frame>30 days</time_frame>
      <description>Hospital Costs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1-Year all-cause health costs</measure>
      <time_frame>1 year</time_frame>
      <description>All health costs over 1 year</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Loss of productivity costs</measure>
      <time_frame>5 years</time_frame>
      <description>Costs associated with loss of productivity from a societal perspective</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">269</enrollment>
    <condition>Cervical Spondylosis With Myelopathy</condition>
    <arm_group>
      <arm_group_label>Anterior Cervical Discectomy and Fusion</arm_group_label>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Posterior Instrumented Cervical Fusion</arm_group_label>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Laminoplasty</arm_group_label>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>ACDF</intervention_name>
      <arm_group_label>Anterior Cervical Discectomy and Fusion</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Posterior Cervical Fusion</intervention_name>
      <arm_group_label>Posterior Instrumented Cervical Fusion</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Cervical Laminoplasty</intervention_name>
      <arm_group_label>Laminoplasty</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Study population consists of patients with multi-level cervical spondylotic myelopathy&#xD;
          without kyphosis and who satisfied clinical equipoise criteria (ventral vs. dorsal&#xD;
          approach) as judged by a panel of at least 15 spine experts.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          -Patients with Cervical Myelopathy (&gt; or equal to 2 levels of spinal cord compression from&#xD;
          C3 to C7) with 2 or more of the following symptoms/ signs: clumsy hands, gait disturbance,&#xD;
          hyperreflexia, upgoing toes, bladder dysfunction.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  C2-C7 kyphosis&gt;5 degrees (measured in standing extension radiograph)&#xD;
  &#xD;
            -  segmental kyphotic deformity (defined by greater than 3 osteophytes extending dorsal&#xD;
               to a C2-C7 dorsal-caudal line measured on cervical spine CT)&#xD;
  &#xD;
            -  structurally significant ossification of the posterior longitudinal ligament (OPLL -&#xD;
               measured on cervical spine CT)&#xD;
  &#xD;
            -  previous cervical spine surgery, or significant active health-related co-morbidity&#xD;
               (Anesthesia Class IV or higher)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Zoher Ghogawala, MD</last_name>
      <role>Study Director</role>
      <affiliation>Lahey Hospital &amp; Medical Center</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Robert G. Whitmore, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Lahey Hospital &amp; Medical Center</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Lahey Hospital &amp; Medical Center</name>
        <address>
          <city>Burlington</city>
          <state>Massachusetts</state>
          <zip>01803</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Mayo Clinic</name>
        <address>
          <city>Rochester</city>
          <state>Minnesota</state>
          <zip>55902</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <results_reference>
      <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.</citation>
      <PMID>33687463</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>cost-effectiveness</keyword>
    <keyword>cervical spondylotic myelopathy</keyword>
    <keyword>health resource utilization</keyword>
    <keyword>spinal fusion</keyword>
    <keyword>laminoplasty</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spondylosis</mesh_term>
      <mesh_term>Spinal Cord Diseases</mesh_term>
      <mesh_term>Bone Marrow Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_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_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Within 6 months of primary publication of the data and for 5 years thereafter</ipd_time_frame>
      <ipd_access_criteria>Researchers with a clear and valid research protocol will be able to gain access to the data.</ipd_access_criteria>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>July 10, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT05994404/Prot_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05994404
  org study id: LCID: 2023
  secondary id: CE-1304-6173
  nct id: NCT05994404
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: Total Health Costs - Societal Perspective
  time frame: 5 years
  description: Index hospitalization costs+one-year all cause costs+loss of productivity costs
  measure: Index Hospitalization Costs
  time frame: 30 days
  description: Hospital Costs
  measure: 1-Year all-cause health costs
  time frame: 1 year
  description: All health costs over 1 year
  measure: Loss of productivity costs
  time frame: 5 years
  description: Costs associated with loss of productivity from a societal perspective
  arm group label: Anterior Cervical Discectomy and Fusion
  description: 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.
  arm group label: Posterior Instrumented Cervical Fusion
  description: 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.
  arm group label: Laminoplasty
  description: 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.
  intervention type: Procedure
  intervention name: ACDF
  arm group label: Anterior Cervical Discectomy and Fusion
  intervention type: Procedure
  intervention name: Posterior Cervical Fusion
  arm group label: Posterior Instrumented Cervical Fusion
  intervention type: Procedure
  intervention name: Cervical Laminoplasty
  arm group label: Laminoplasty
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 45 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Zoher Ghogawala, MD
  role: Study Director
  affiliation: Lahey Hospital & Medical Center
  last name: Robert G. Whitmore, MD
  role: Principal Investigator
  affiliation: Lahey Hospital & Medical Center
  facility: 
  facility: 
  country: United States
  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.
  PMID: 33687463
  responsible party type: Sponsor
  mesh term: Spondylosis
  mesh term: Spinal Cord Diseases
  mesh term: Bone Marrow Diseases
  sharing ipd: Yes
  ipd 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 info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Within 6 months of primary publication of the data and for 5 years thereafter
  ipd access criteria: Researchers with a clear and valid research protocol will be able to gain access to the data.
  provided document: 