The Collar Post Anterior Cervical Spine Surgery Study (C-PASS)

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.

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.

Study Overview

• Status: Unknown
• Conditions: Cervical Radiculopathy; Cervical Myelopathy
• Intervention / Treatment: Device: Cervical collar

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 Type: Interventional
• Enrollment (Anticipated): 244
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • Recruiting
      • St. Michael's Hospital
      • Contact: Kayee Tung, RN
      • Principal Investigator: Jefferson R Wilson, MD, FRCSC
      • Sub-Investigator: Howard Ginsberg, MD,FRCSC
      • Sub-Investigator: Henry Ahn, MD, FRCSC
  • Quebec
    • Montréal, Quebec, Canada, H3G 1A4
      • Recruiting
      • Hôpital Général de Montréal Montreal General Hospital
      • Contact: Francis Colagiacomo, B.A; Phone Number: 45496 514.934.1934

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No post-operative bracing; patients in this arm will not be prescribed a cervical collar following anterior cervical discectomy and fusion surgery
Active Comparator: Post-operative bracing; Patients in this arm will be prescribed a cervical collar following anterior cervical discectomy and fusion surgery.	Device: Cervical collar; cervical collars prescribed will be use immediately following anterior cervical discectomy and fusion surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
EQ-5D	a standardized instrument for measuring generic health status.	3, 6, 12 month
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
Plain Xray Radiography	An X-ray is a quick, painless test that produces images of the structures inside your body	6 week, 12 month

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Investigators: Principal Investigator: Jefferson Wilson, MD, FRCSC, Unity Health Toronto

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2018
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: February 13, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy; Spinal Cord Diseases
• Other Study ID Numbers: C-PASS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No