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Recruiting NCT07789288

Hard Cervical Collar Use Following Posterior Cervical Fusion

Conditions: Spinal Stenosis Cervical, Radiculopathy, Cervical Region, Posterior Cervical Fusion, Spondylosis, Cervical

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: Georgetown University

Location: MedStar Georgetown University Hospital Washington D.C. District of Columbia

Summary

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07789288). StuddyBuddy aggregates publicly available trial information.