The Collar Post Anterior Cervical Spine Surgery Study

NCT03842072 | Unknown

• 1 other identifier: C-PASS
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Neck Disability index

  This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life.

  6 month

Secondary Outcomes (4)

• Neck Disability Index

  3 and 12 month

• EQ-5D

  3, 6, 12 month

• Visual analog score

  3, 6, 12 month

• Plain Xray Radiography

  6 week, 12 month

Study Arms (2)

No post-operative bracing

NO INTERVENTION

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

Post-operative bracing

ACTIVE COMPARATOR

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

Device: Cervical collar

Interventions

Cervical collar DEVICE

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

Post-operative bracing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (2)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Hôpital Général de Montréal Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

RECRUITING

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Jefferson Wilson, MD, FRCSC

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kayee Tung

CONTACT

416.864.6060; tungk@smh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 15, 2019
• Study Start: February 23, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2021
• Last Updated: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)