150 Participants NeededMy employer runs this trial

Hard Cervical Collar for Neck Arthritis

Recruiting at 1 trial location
AA
Overseen ByAmjad Anaizi, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Georgetown University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with degenerative disk disease.
Ability to provide informed consent
I am 18 years old or older.
See 1 more

Exclusion Criteria

I have trauma, a tumor, or an infection.

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: CollarExperimental Treatment1 Intervention
Group II: No collarActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials
355
Recruited
142,000+