150 Participants NeededMy employer runs this trial

Hard Cervical Collar for Neck Arthritis

Recruiting at 1 trial location
MJ
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.

Who Is on the Research Team?

AA

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either wear a hard cervical collar for 6 weeks after surgery or receive no cervical collar

6 weeks
Visits at 2 weeks and 6 weeks post-surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple time points

12 months
Visits at 12 weeks, 6 months, and 12 months post-surgery

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

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+