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Randomized Controlled Trial
. 2014 Oct;75(4):334-46.
doi: 10.1227/NEU.0000000000000479.

Cervical spondylotic myelopathy surgical trial: randomized, controlled trial design and rationale

Zoher Ghogawala  1 , Edward C Benzel, Robert F Heary, K Daniel Riew, Todd J Albert, William E Butler, Fred G Barker 2nd, John G Heller, Paul C McCormick, Robert G Whitmore, Karen M Freund, J Sanford Schwartz
Affiliations
Randomized Controlled Trial

Cervical spondylotic myelopathy surgical trial: randomized, controlled trial design and rationale

Zoher Ghogawala et al. Neurosurgery. 2014 Oct.

Abstract

Background: Cervical spondylotic myelopathy (CSM) is the most common cause of spinal cord dysfunction in the world. There are significant practice variation and uncertainty as to the optimal surgical approach for treating CSM.

Objective: To determine whether ventral surgery is associated with superior Short Form-36 Physical Component Summary outcome at the 1-year follow-up compared with dorsal (laminectomy/fusion or laminoplasty) surgery for the treatment of CSM, to investigate whether postoperative sagittal balance is an independent predictor of overall outcome, and to compare health resource use for ventral and dorsal procedures.

Methods: The study is a randomized, controlled trial with a nonrandomized arm for patients who are eligible but decline randomization. Two hundred fifty patients (159 randomized) with CSM from 11 sites will be recruited over 18 months. The primary outcome is the Short Form-36 Physical Component Summary score. Secondary outcomes include disease-specific outcomes, overall health-related quality of life (EuroQOL 5-dimension questionnaire), and health resource use.

Expected outcomes: This will be the first randomized, controlled trial to compare directly the health-related quality-of-life outcomes for ventral vs dorsal surgery for treating CSM.

Discussion: A National Institutes of Health-funded (1R13AR065834-01) investigator meeting was held before the initiation of the trial to bring multiple stakeholders together to finalize the study protocol. Study investigators, coordinators, and major stakeholders were able to attend and discuss strengths of, limitations of, and concerns about the study. The final protocol was approved for funding by the Patient-Centered Outcomes Research Institute (CE-1304-6173). The trial began enrollment on April 1, 2014.

Trial registration: ClinicalTrials.gov NCT02076113.

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Figures

Figure 1
Figure 1
Both ventral and dorsal surgery were associated with improvement in myelopathy scores (mJOA) (A), but ventral surgery was associated with superior HR-QOL outcomes compared to dorsal approaches (P = 0.07) (B).
Figure 1
Figure 1
Both ventral and dorsal surgery were associated with improvement in myelopathy scores (mJOA) (A), but ventral surgery was associated with superior HR-QOL outcomes compared to dorsal approaches (P = 0.07) (B).
Figure 2
Figure 2
Patients with sagittal balance greater than 4 cm post-operatively did not experience improvement in HR-QOL following surgery. In contrast, patients with relatively normal cervical sagittal balance experienced an 8.8 point improvement in SF-36 PCS at one year post-operatively.
Figure 3
Figure 3
A-D: Flexion-Extension Images, Sagittal CT and MRI images for CSM case judged eligible for study. E: Spinal Experts' Review. All 9 investigators found the case eligible for randomization. The preferred approach is also shown for each of the voting investigators.
Figure 3
Figure 3
A-D: Flexion-Extension Images, Sagittal CT and MRI images for CSM case judged eligible for study. E: Spinal Experts' Review. All 9 investigators found the case eligible for randomization. The preferred approach is also shown for each of the voting investigators.
Figure 3
Figure 3
A-D: Flexion-Extension Images, Sagittal CT and MRI images for CSM case judged eligible for study. E: Spinal Experts' Review. All 9 investigators found the case eligible for randomization. The preferred approach is also shown for each of the voting investigators.
Figure 3
Figure 3
A-D: Flexion-Extension Images, Sagittal CT and MRI images for CSM case judged eligible for study. E: Spinal Experts' Review. All 9 investigators found the case eligible for randomization. The preferred approach is also shown for each of the voting investigators.
Figure 3
Figure 3
A-D: Flexion-Extension Images, Sagittal CT and MRI images for CSM case judged eligible for study. E: Spinal Experts' Review. All 9 investigators found the case eligible for randomization. The preferred approach is also shown for each of the voting investigators.
Figure 4
Figure 4
Randomization schema for the CSM-S trial.
Figure 5
Figure 5
CSM-S Study Website.
Figure 6
Figure 6
CSM-S study schema.
Figure 7
Figure 7
Agenda for the NIH funded (1R13AR065834-01) CSM-S Investigator Meeting.
Figure 8
Figure 8
Administrative organization of the CSM-S study.
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