NCT03842072

The Collar Post Anterior Cervical Spine Surgery Study

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 244 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Cervical collar	cervical collars prescribed will be use immediately following anterior cervical discectomy and fusion surgery.

Timeline

• Start date: 2018-02-23
• Primary completion: 2020-07-01
• Completion: 2021-07-01
• First posted: 2019-02-15
• Last updated: 2019-09-18

Locations

2 sites across 1 country: Canada