Status:
UNKNOWN
The Collar Post Anterior Cervical Spine Surgery Study
Lead Sponsor:
Unity Health Toronto
Conditions:
Cervical Radiculopathy
Cervical Myelopathy
Eligibility:
All Genders
18-80 years
Phase:
NA
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 seco...
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 seco...
Eligibility Criteria
Inclusion
- 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. 5. Participants who are able to speak, read and write at an elementary school level
Exclusion
- 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.
Key Trial Info
Start Date :
February 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT03842072
Start Date
February 23 2018
End Date
July 1 2021
Last Update
September 18 2019
Active Locations (2)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
2
Hôpital Général de Montréal Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4