Clinical Trial: Cervical Spondylotic Myelopathy Surgical Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Cervical Spondylotic Myelopathy Surgical Trial

Brief Summary:

The purpose of the study is to determine the optimal surgical approach (ventral vs dorsal) for patients with multi-level cervical spondylotic myelopathy (CSM). There are no established guidelines for the management of patients with CSM, which represents the most common cause of spinal cord injury and dysfunction in the US and in the world.

This study aims to test the hypothesis that ventral surgery is associated with superior Short Form-36 physical component Score (SF-36 PCS) outcome at one year follow-up compared to dorsal approaches and that both ventral and dorsal surgery improve symptoms of spinal cord dysfunction measured using the modified Japanese Orthopedic Association Score (mJOA). A secondary hypothesis is that health resource utilization for ventral surgery, dorsal fusion, and laminoplasty surgery are different. A third hypothesis is that cervical sagittal balance post-operatively is a significant predictor of SF-36 PCS outcome.


Detailed Summary:

Patients' images will be transmitted electronically (without identifying information) to a group of 15 CSM surgeon investigators for their expert opinion. They will provide their opinion on surgical strategy. Equipoise for randomization will be established using this spinal experts network polling mechanism.

If randomized, the patient will be randomized to one of the two treatment approaches - either Ventral (front) (treatment A) or Dorsal (back) (treatment B) approach. If randomized to treatment A (front surgery), the patient will receive decompression/fusion from the front of the neck. If randomized to treatment B (dorsal/back surgery), then the patient and their surgeon will select which posterior procedure they will receive (either dorsal decompression/fusion or dorsal laminoplasty).

Treatment A: Decompression/fusion from the front of the neck.

Treatment B: Dorsal/posterior neck surgery (one of the two surgical procedures listed below):

Dorsal decompression/fusion or dorsal laminoplasty (no fusion)

Functional outcomes will be determined using well-known quantitative scales (SF-36, Oswestry Neck Disability Index (NDI), mJOA, and EuroQol-5D). These instruments will be administered pre-op, 3 months, 6 months, and at 1 year. Additionally, functional outcomes instruments (SF-36, Oswestry Neck Disability Index, and EuroQol-5D) will be collected annually at years 2,3,4 and 5.

Pre-op imaging will include a cervical MRI and cervical CT as well as cervical flexion/extension films and standing cervical-thoracic-lumbar-sacral x-ray . A cervical MRI will be performed at 3 months. At 1 year (randomized patients only) will undergo cervic
Sponsor: Lahey Clinic

Current Primary Outcome: Measurement of change in Short Form 36 (SF 36) physical component score (PCS) from baseline to 1 year [ Time Frame: Pre-operatively and 1 year ]

Standardized measure of patient's functional health and well being as reported by the patient


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • modified Japanese Orthopedic Association Score mJOA [ Time Frame: Pre-operatively, 3 and 6 months and 1 year ]
    Short instrument for the functional assessment of patients
  • Oswestry Neck Disability Index (NDI) [ Time Frame: Pre-operatively, 3 and 6 months and 1 year ]
    Standard instrument for measuring self-rated disability secondary to neck pain
  • EuroQol-5 D [ Time Frame: Pre-operatively, 3 and 6 months and 1 year ]
    Standardized measure of health related quality of life.
  • Number of participants with 30 day complications [ Time Frame: 30 days ]
    Complications are considered Hospital Readmission, Re-operation or Death within 30 days of initial surgery
  • Health resource utilization [ Time Frame: Pre-operatively, 1, 3 and 6 months and 1 year ]
    patient diary capturing out of pocket health expenses related to cervical surgery
  • Work Status [ Time Frame: pre-operative, 1, 3 and 6 months and 1 year ]
  • Sagittal Balance Measurements [ Time Frame: Pre-op and 1 year ]
    standing cervical-thoracic-lumbar-sacral xrays
  • Number of participants with unresolved swallowing difficulty (complication) at 3 months [ Time Frame: 3 months ]
    Complication is considered swallowing difficulty


Original Secondary Outcome:

  • modified Japanese Orthopedic Association Score mJOA [ Time Frame: Pre-operatively, 3 and 6 months and 1 year ]
    Short instrument for the functional assessment of patients
  • Oswestry Neck Disability Index (NDI) [ Time Frame: Pre-operatively, 3 and 6 months and 1 year ]
    Standard instrument for measuring self-rated disability secondary to neck pain
  • EuroQol-5 D [ Time Frame: Pre-operatively, 3 and 6 months and 1 year ]
    Standardized measure of health related quality of life.
  • observed complication rates [ Time Frame: 30 days ]
  • Health resource utilization [ Time Frame: Pre-operatively, 1, 3 and 6 months and 1 year ]
    patient diary capturing out of pocket health expenses related to cervical surgery
  • Work Status [ Time Frame: pre-operative, 1, 3 and 6 months and 1 year ]
  • Sagittal Balance Measurements [ Time Frame: Pre-op and 1 year ]
    standing cervical-thoracic-lumbar-sacral xrays


Information By: Lahey Clinic

Dates:
Date Received: February 26, 2014
Date Started: April 2014
Date Completion: June 2021
Last Updated: March 6, 2017
Last Verified: December 2016