The Collar Post Anterior Cervical Spine Surgery Study

Study Overview
=================
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.

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.

Conditions
-----------------
Cervical Radiculopathy, Cervical Myelopathy

Intervention / Treatment
-----------------
* Device: Cervical collar


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 |