The CSM Trial: A Multicenter Study Comparing Ventral to Dorsal Surgery for Cervical Spondylotic Myelopathy (CSM)
|ClinicalTrials.gov Identifier: NCT00506558|
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : August 29, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Spondylotic Myelopathy||Procedure: Ventral Surgical Decompression with Instrumented Fusion Procedure: Dorsal Decompression With or Without Fusion||Phase 3|
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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
- Prospective, non-randomized multicenter trial. Approximately 100-200 patients would be recruited over one year with follow-up at one year.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- Any serious anticipated adverse event (e.g. wound infection, pulmonary embolus) will be reported to the IRB whenever their magnitude or frequency exceeds expectations.
- 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
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).
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.
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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The CSM Trial: A Multicenter Study Comparing Ventral to Dorsal Surgery for Cervical Spondylotic Myelopathy|
|Study Start Date :||November 2006|
|Primary Completion Date :||May 2012|
|Study Completion Date :||May 2012|
Ventral Decompression and Instrumented Fusion
Procedure: Ventral Surgical Decompression with Instrumented Fusion
Multi-level discectomy or Corpectomy are performed at surgeon's discretion. After decompression an instrumented fusion is performed.
Active Comparator: B
Dorsal Decompression with or without fusion
Procedure: Dorsal Decompression With or Without Fusion
Dorsal decompressive laminectomy, laminoplasty, or laminectomy with lateral mass instrumented fusion
- Oswestry Neck Disability Index, mJOA, major complication rate [ Time Frame: 1 year ]
- SF-36 physical component summary (PCS), EuroQol-5D [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506558
|United States, Connecticut|
|Danbury, Connecticut, United States, 06810|
|Greenwich, Connecticut, United States, 06830|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Burlington, Massachusetts, United States, 01805|
|United States, New Jersey|
|University of Medicine and Dentistry - New Jersey|
|Newark, New Jersey, United States, 07103|
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|United States, Utah|
|University of Utah HSC|
|Salt Lake City, Utah, United States, 84132-2303|
|Study Director:||Zoher Ghogawala, MD, FACS||Greenwich Hospital - Yale Universtiy School of Medicine|
|Principal Investigator:||Edward C. Benzel, MD||The Cleveland Clinic|
|Principal Investigator:||Robert Heary, MD||University of Medicine and Dentistry of New Jersey|
|Principal Investigator:||Ronald Apfelbaum||University of Utah|
|Principal Investigator:||Jean-Valery Coumans, MD||Massachusetts General Hospital|
|Principal Investigator:||Subu N Magge, MD||Lahey Clinic|