Hard Cervical Collar for Neck Arthritis
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.
Who Is on the Research Team?
Amjad Anaizi, MD
Principal Investigator
MedStar Georgetown University Hospital
Are You a Good Fit for This Trial?
This trial is for adults (18+) with neck problems like arthritis, pinched nerves, or spinal narrowing who are having posterior cervical fusion surgery for degenerative spine disease. People with neck injuries from trauma, tumors, or infections cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to either wear a hard cervical collar for 6 weeks after surgery or receive no cervical collar
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at multiple time points
What Are the Treatments Tested in This Trial?
Interventions
- Hard Cervical Collar
Trial Overview
The study compares wearing a hard neck collar versus no collar for 6 weeks after cervical spine fusion surgery. Patients are randomly assigned to either group and followed up over a year to see if the collar helps healing and recovery.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Hard Cervical Collar for 6 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
Georgetown University
Lead Sponsor
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