The Collar Post Anterior Cervical Spine Surgery Study

Cervical Radiculopathy Clinical Trial

— C-PASS  

Official title:

The Collar Post Anterior Cervical Spine Surgery (C-PASS) Study: Project Proposal for a Multi-Center Randomized Trial Evaluating the Impact of Post-Operative Bracing on Clinical Outcomes After Anterior Cervical Discectomy and Fusion.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03842072
• Other study ID #: C-PASS
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2018
• Est. completion date: July 1, 2021

Study information

• Verified date: September 2019
• Source: St. Michael's Hospital, Toronto
• Contact: Kayee Tung
• Phone: 416.864.6060
• Email: tungk[@]smh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 244
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Myelopathy
• Cervical Radiculopathy
• Radiculopathy
• Spinal Cord Diseases

Intervention

Device:
• Cervical collar
cervical collars prescribed will be use immediately following anterior cervical discectomy and fusion surgery.

Locations

Country	Name	City	State
Canada	Hôpital Général de Montréal Montreal General Hospital	Montréal	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	3 and 12 month
Secondary	EQ-5D	a standardized instrument for measuring generic health status.	3, 6, 12 month
Secondary	Visual analog score	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.	3, 6, 12 month
Secondary	Plain Xray Radiography	An X-ray is a quick, painless test that produces images of the structures inside your body	6 week, 12 month