Hard Cervical Collar Use Following Posterior Cervical Fusion
Purpose
Postoperative immobilization with a hard cervical collar following posterior cervical fusion remains common practice despite limited evidence demonstrating improved clinical outcomes. This is a prospective, multi-site, randomized clinical trial evaluating postoperative hard cervical collar use following posterior cervical fusion for degenerative cervical spine disease. Eligible patients will be randomized to either wear an FDA-approved hard cervical collar (Aspen Cervical Collar, Aspen Vista Cervical Collar, or Miami J Cervical Collar) for 6 weeks after surgery or receive no cervical collar. Patient-reported outcomes will be collected before surgery and at 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months after surgery. The primary outcome is radiographic fusion success at 12 months. Secondary outcomes include neck disability, neck and arm pain, quality of life, patient satisfaction, wound infection, adverse events, and other postoperative complications. Radiographic fusion will be evaluated by blinded radiologists. The results of this study will help determine whether routine postoperative cervical collar use improves outcomes following posterior cervical fusion.
Conditions
- Spinal Stenosis Cervical
- Radiculopathy, Cervical Region
- Posterior Cervical Fusion
- Spondylosis, Cervical
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Adults aged 18 years or older - Diagnosis of degenerative disk disease (DDD) - Ability to provide informed consent - Patients with cervical spondylotic myelopathy, cervical deformity, or pseudoarthrosis
Exclusion Criteria
- Patients with trauma, tumors, or infections
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Collar |
Hard Cervical Collar for 6 weeks |
|
|
No Intervention No collar |
|
Recruiting Locations
Washington D.C., District of Columbia 20007
Washington D.C., District of Columbia 22209
More Details
- Status
- Recruiting
- Sponsor
- Georgetown University