The Collar Post Anterior Cervical Spine Surgery (C-PASS) Study: Project Proposal for a Multi-Center Randomized Trial Evaluating the Impact of Post-Operative Bracing on Clinical Outcomes After Anterior Cervical Discectomy and Fusion.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cervical Radiculopathy
- Sponsor
- Unity Health Toronto
- Enrollment
- 244
- Locations
- 2
- Primary Endpoint
- Neck Disability index
- Last Updated
- 6 years ago
Overview
Brief Summary
The Anterior Cervical Discectomy and Fusion (ACDF) represents one of the most commonly performed spinal operations internationally, often in the context of symptomatic radiculopathy or myelopathy secondary to cervical degenerative disease. Approximately half of surgeons continue to prescribe a period of post-operative bracing with a cervical collar. However, there is currently no high quality evidence available to support the routine use of post-operative bracing after ACDF; further, braces are expensive and have been associated with a variety of local complications. In summary, the current lack of evidence, and lack of consensus amongst surgeons, regarding best practices in the use of post-operative bracing after ACDF, places the surgeon and the patient in a precarious position.
Our randomized trial comparing the impact of 6 weeks of post-operative bracing with a rigid cervical collar vs. no post-operative bracing, on a variety of clinical and radiological outcomes, for adult patients with cervical radiculopathy and/or myelopathy undergoing single or multi-level ACDF.
Detailed Description
The Anterior Cervical Discectomy and Fusion (ACDF) represents one of the most commonly performed spinal operations internationally, often in the context of symptomatic radiculopathy or myelopathy secondary to cervical degenerative disease. Approximately half of surgeons continue to prescribe a period of post-operative bracing with a cervical collar. However, there is currently no high quality evidence available to support the routine use of post-operative bracing after ACDF; further, braces are expensive and have been associated with a variety of local complications. In summary, the current lack of evidence, and lack of consensus amongst surgeons, regarding best practices in the use of post-operative bracing after ACDF, places the surgeon and the patient in a precarious position.
Investigators
Eligibility Criteria
Inclusion Criteria
- •between the ages of 18 and 80;
- •presenting with cervical radiculopathy and/or myelopathy to one of the study centers;
- •deemed appropriate by the attending surgeon involved for a one, two or three level plated ACDF or a one-level ACDF with a standalone interbody cage; and
- •able to cooperate in the completion of all study consents, forms and documents.
- •Participants who are able to speak, read and write at an elementary school level
Exclusion Criteria
- •those with previous cervical surgery;
- •those undergoing single or multi-level plated ACDF for a diagnosis related to malignancy, infection or trauma;
- •those undergoing a single or multi-level plated ACDF augmented with a posterior cervical fusion or posterior cervical decompression and fusion;
- •those undergoing a multi-level non-plated ACDF;
- •those undergoing ACDF at greater than three levels, and;
- •those with a pre-existent neurological or mental disorder which would preclude accurate evaluation and follow-up.
Outcomes
Primary Outcomes
Neck Disability index
Time Frame: 6 month
This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life.
Secondary Outcomes
- EQ-5D(3, 6, 12 month)
- Visual analog score(3, 6, 12 month)
- Neck Disability Index(3 and 12 month)
- Plain Xray Radiography(6 week, 12 month)