The Collar Post Anterior Cervical Spine Surgery Study

Not Applicable

• Conditions: Cervical Myelopathy; Cervical Radiculopathy
• Interventions: Device: Cervical collar

• Registration Number: NCT03842072
• Lead Sponsor: Unity Health Toronto

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.

Study Timeline

• Study Start: 2018-02-23
• Study First Submitted: 2019-02-13
• Study First Submitted QC: 2019-02-13
• Study First Posted: 2019-02-15
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-18
• Primary Completion: 2020-07-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 244

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post-operative bracing	Cervical collar	Patients in this arm will be prescribed a cervical collar following anterior cervical discectomy and fusion surgery.

Primary Outcome Measures

Name	Time	Method
Neck Disability index	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 Outcome Measures

Name	Time	Method
EQ-5D	3, 6, 12 month	a standardized instrument for measuring generic health status.
Visual analog score	3, 6, 12 month	a measurement instrument for pain where pain is measured from a score of 0 (represents no pain), and 10 (most pain, or worst pain imaginable.
Neck Disability Index	3 and 12 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.
Plain Xray Radiography	6 week, 12 month	An X-ray is a quick, painless test that produces images of the structures inside your body

Trial Locations

Locations (2)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Hôpital Général de Montréal Montreal General Hospital; 🇨🇦 Montréal, Quebec, Canada