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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No post-operative bracing | No Intervention | patients in this arm will not be prescribed a cervical collar following anterior cervical discectomy and fusion surgery | |
| Post-operative bracing | Active Comparator | Patients in this arm will be prescribed a cervical collar following anterior cervical discectomy and fusion surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical collar | Device | cervical collars prescribed will be use immediately following anterior cervical discectomy and fusion surgery. |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kayee Tung | Contact | 416.864.6060 | 2713 | tungk@smh.ca |
| Name | Affiliation | Role |
|---|---|---|
| Jefferson Wilson, MD, FRCSC | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Recruiting | Toronto | Ontario | M5B 1W8 | Canada |
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| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| 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 |
| Hôpital Général de Montréal Montreal General Hospital | Recruiting | Montreal | Quebec | H3G 1A4 | Canada |
|