NCT07789288 Hard Cervical Collar Use Following Posterior Cervical Fusion
| NCT ID | NCT07789288 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Georgetown University |
| Condition | Spinal Stenosis Cervical |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-06-03 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2026-06-03 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07789288 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Stenosis Cervical. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07789288 currently recruiting?
Yes, NCT07789288 is actively recruiting participants. Contact the research team at Amjad.N.Anaizi@gunet.georgetown.edu for enrollment information.
Where is the NCT07789288 trial being conducted?
This trial is being conducted at Washington D.C., United States, Washington D.C., United States.
Who is sponsoring the NCT07789288 clinical trial?
NCT07789288 is sponsored by Georgetown University. The trial plans to enroll 150 participants.