The Collar Post Anterior Cervical Spine Surgery Study

NCT ID: NCT03842072

Last Updated: 2019-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-23
• Study Completion Date: 2021-07-01

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.

Conditions

Cervical Radiculopathy; Cervical Myelopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No post-operative bracing

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Post-operative bracing

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

Group Type: ACTIVE_COMPARATOR

Cervical collar

Intervention Type: DEVICE

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

Interventions

Cervical collar

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jefferson Wilson, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Hôpital Général de Montréal Montreal General Hospital

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Kayee Tung

Role: CONTACT

tungk@smh.ca

416.864.6060 ext. 2713

Facility Contacts

Kayee Tung, RN

Role: primary

Francis Colagiacomo, B.A

Role: primary

514.934.1934 ext. 45496

Other Identifiers

C-PASS

Identifier Type: -

Identifier Source: org_study_id