Recruiting

Collar Post Surgery

Sponsor:

Unity Health Toronto

Code:

NCT03842072

Conditions

Cervical Radiculopathy

Cervical Myelopathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Cervical collar

Study Details

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.

Conditions

Cervical Radiculopathy

Cervical Myelopathy

Study ID

NCT03842072

Start date

Feb 23, 2018

Status verified date

Sep, 2019

Completion date

Jul 1, 2021

Anticipated

Primary completion date

Jul 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. between the ages of 18 and 80;
2. presenting with cervical radiculopathy and/or myelopathy to one of the study centers;
3. 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
4. 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 Criteria:

1. those with previous cervical surgery;
2. those undergoing single or multi-level plated ACDF for a diagnosis related to malignancy, infection or trauma;
3. those undergoing a single or multi-level plated ACDF augmented with a posterior cervical fusion or posterior cervical decompression and fusion;
4. those undergoing a multi-level non-plated ACDF;
5. those undergoing ACDF at greater than three levels, and;
6. those with a pre-existent neurological or mental disorder which would preclude accurate evaluation and follow-up.

Study Design

Enrollment

244 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: No post-operative bracing

patients in this arm will not be prescribed a cervical collar following anterior cervical discectomy and fusion surgery

active comparator: Post-operative bracing

Patients in this arm will be prescribed a cervical collar following anterior cervical discectomy and fusion surgery.

Interventions

Cervical collar

cervical collars prescribed will be use immediately following anterior cervical discectomy and fusion surgery.

Primary outcome measure

  • Neck Disability index [ Time Frame: 6 month ]

Central Contacts and Locations

Central contacts

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Principal Investigator:

Jefferson R Wilson, MD, FRCSC

Hôpital Général de Montréal Montreal General Hospital

Recruiting

Montréal, Quebec, Canada, H3G 1A4

Contacts

Francis Colagiacomo, B.A

514.934.1934

More Information

Sponsor

Unity Health Toronto

Last update posted

Sep 18, 2019

Last verified

Sep, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2019-09-18.