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

Primary Purpose

Cervical Radiculopathy, Cervical Myelopathy

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cervical collar
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radiculopathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Michael's HospitalRecruiting
  • Hôpital Général de Montréal Montreal General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

No post-operative bracing

Post-operative bracing

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
EQ-5D
a standardized instrument for measuring generic health status.
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.
Plain Xray Radiography
An X-ray is a quick, painless test that produces images of the structures inside your body

Full Information

First Posted
February 13, 2019
Last Updated
September 17, 2019
Sponsor
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03842072
Brief Title
The Collar Post Anterior Cervical Spine Surgery Study
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 23, 2018 (Actual)
Primary Completion Date
July 1, 2020 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy, Cervical Myelopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
244 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No post-operative bracing
Arm Type
No Intervention
Arm Description
patients in this arm will not be prescribed a cervical collar following anterior cervical discectomy and fusion surgery
Arm Title
Post-operative bracing
Arm Type
Active Comparator
Arm Description
Patients in this arm will be prescribed a cervical collar following anterior cervical discectomy and fusion surgery.
Intervention Type
Device
Intervention Name(s)
Cervical collar
Intervention Description
cervical collars prescribed will be use immediately following anterior cervical discectomy and fusion surgery.
Primary Outcome Measure Information:
Title
Neck Disability index
Description
This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Neck Disability Index
Description
This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life.
Time Frame
3 and 12 month
Title
EQ-5D
Description
a standardized instrument for measuring generic health status.
Time Frame
3, 6, 12 month
Title
Visual analog score
Description
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.
Time Frame
3, 6, 12 month
Title
Plain Xray Radiography
Description
An X-ray is a quick, painless test that produces images of the structures inside your body
Time Frame
6 week, 12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kayee Tung
Phone
416.864.6060
Ext
2713
Email
tungk@smh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jefferson Wilson, MD, FRCSC
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kayee Tung, RN
First Name & Middle Initial & Last Name & Degree
Jefferson R Wilson, MD, FRCSC
First Name & Middle Initial & Last Name & Degree
Howard Ginsberg, MD,FRCSC
First Name & Middle Initial & Last Name & Degree
Henry Ahn, MD, FRCSC
Facility Name
Hôpital Général de Montréal Montreal General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francis Colagiacomo, B.A
Phone
514.934.1934
Ext
45496

12. IPD Sharing Statement

Plan to Share IPD
No

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The Collar Post Anterior Cervical Spine Surgery Study

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