The CSM Trial: A Multicenter Study Comparing Ventral to Dorsal Surgery for Cervical Spondylotic Myelopathy
Condition: Cervical Spondylotic Myelopathy
MeSH terms: Spinal Cord Diseases; Bone Marrow Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine the optimal surgical approach (ventral versus
      dorsal) for patients with multi-level cervical spondylotic myelopathy (CSM). There are no
      established guidelines for the management of patients with CSM, which slowly causes spinal
      cord injury in afflicted patients.

      This study aims to test the hypothesis that ventral surgery (decompressing the spinal cord
      from the front of the neck) and dorsal surgery (decompressing the spinal cord from the back
      of the neck) might differ in their overall outcome or major complication rate.
    

Detailed description: 
      A. Purpose To determine the optimal surgical approach (ventral versus dorsal) for patients
      with multi-level cervical spondylotic myelopathy (CSM).

      B. Background There are no established guidelines for the management of patients with CSM. It
      is estimated that up to 30 percent of patients have an unsatisfactory outcome after surgery
      for CSM. It remains uncertain how dorsal and ventral approaches differ in their success rates
      and in their complication rates. This study aims to test the hypothesis that ventral and
      dorsal surgical approaches differ in their outcomes or major complication rates. A secondary
      hypothesis is that fusion might improve outcome by reducing repetitive shear injury to the
      spinal cord.

      C. Specific Location of Study

      This is a multi-center trial. Subjects will be entered into the study from 9 separate
      centers. At this site, subjects will be recruited from the office of Dr. Zoher Ghogawala. All
      subjects at this site will undergo surgery at Greenwich Hospital.

      D. Probable Duration of Project

      Subjects will be recruited into the study for one year. All subjects will be followed for 1
      year.

      E. Research Plan

        1. Prospective, non-randomized multicenter trial. Approximately 100-200 patients would be
           recruited over one year with follow-up at one year.

        2. Subjects (aged 40-85 years) with spinal cord compression (2 or more levels) from
           degenerative cervical spondylosis with clinical myelopathy will be treated with either
           ventral decompression/fusion or dorsal decompression with or without fusion.

        3. Subjects with cervical kyphosis > 5˚, a segmental kyphotic deformity defined as 3 or
           more disc-osteophytes that extend dorsal to a line drawn from the dorsal caudal point of
           C2 to the dorsal caudal point of C7, ossification of the posterior longitudinal ligament
           (OPLL), or developmental spinal canal narrowing (12mm) would be excluded from the study.

        4. Functional outcomes will be determined using well-known quantitative scales (SF-36,
           Oswestry Neck, mJOA, Nurick, and EuroQol-5D). These instruments will be administered
           pre-op, 3 months, 6 months, and 1 year post-op.

        5. Two independent neuroradiologists will review the initial films to confirm eligibility
           and review post-operative films (3 months, 6 months, and 1 year) to determine
           radiographic decompression and fusion as well as any complications.

        6. An independent study coordinator will collect data at 30 days and at 1 year to document
           any complications or re-operations.

      F. Data and Safety Monitoring Plan

        1. All serious unexpected adverse events (e.g. death within 30 days of operation) will be
           reported to the IRB within 24 hours. Any appropriate funding agencies or regulatory
           agencies would be notified as well.

        2. Any serious anticipated adverse event (e.g. wound infection, pulmonary embolus) will be
           reported to the IRB whenever their magnitude or frequency exceeds expectations.

        3. All other adverse events (including loss of privacy, significant economic harm) will be
           reported to the IRB on an annual basis or at the time that re-approval is sought. Any
           adverse event judged unlikely or unrelated to the study will also be included in an
           annual report for the IRB.

      G. Statistical Considerations

        1. Specific data variables being collected for the study.

           The data collection sheets will be submitted along with this protocol. There will be
           several data sheets as follows: 1) Spine surgeon's data sheet, 2) 30-day and 6-month
           morbidity data sheet, 3)1-year morbidity data sheet, 4) SF-36 questionnaires (pre-op, 3
           months, 6 months, 1 year), 5) Oswestry Neck Disability Index questionnaires (pre-op, 3
           months, 6 months, 1 year), 6)mJOA, (pre-op, 3 months, 6 months, 1 year), 7) Nurick
           questionnaire (pre-op, 3 months, 6 months, 1 year), 8)EuroQol-5D (pre-op, 3 months, 6
           months, 1 year), 9)Radiology Review (pre-op, 3 months, 6 months, 1 year, 2 years).

        2. Study endpoints.

           Patients will be followed for 1 year. The primary endpoints will be the SF-36 physical
           component summary score (PCS) and the Oswestry Neck Disability Index. Secondary
           endpoints will include the Nurick, mJOA, and EuroQol-5D scores as well as the observed
           complication rates. Radiographic fusion, instability, and deformity will also be
           secondary outcomes.

        3. Statistical Methods.

           Analysis will focus on the physical component summary (PCS) of the SF-36, the Oswestry
           Neck Disability index, and the major complication rate. The t-test will be used to
           compare the groups for continuous variables such as the SF-36 PCS and the Oswestry Neck
           Disability Index. The Chi-square test will be used to compare the group's complication
           rates. Multiple regression techniques will be applied to control for potential
           confounders including age, medical condition, number of stenotic levels, degree of
           lordosis or kyphosis, etc.

        4. Power Analysis.

      The data generated from the SF-36 or the Oswestry Neck Disability Index will be used to
      calculate sample size for a future randomized controlled trial (RCT) comparing ventral to
      dorsal surgery. If no significant differences are identified in these primary outcomes
      measures, then a sample size calculation will be done using any differences in major
      complication rates.
    

Intervention name(s): Ventral Surgical Decompression with Instrumented Fusion; Dorsal Decompression With or Without Fusion
Intervention type(s): Procedure; Procedure
Intervention description(s): Multi-level discectomy or Corpectomy are performed at surgeon's discretion. After decompression an instrumented fusion is performed.; Dorsal decompressive laminectomy, laminoplasty, or laminectomy with lateral mass instrumented fusion
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cervical spondylotic myelopathy; degenerative cervical spondylosis; spinal fusion