Hard Cervical Collar Use Following Posterior Cervical Fusion

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT07789288
Status
Recruiting
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Conditions

  • Posterior Cervical Fusion
  • Radiculopathy, Cervical Region
  • Spinal Stenosis Cervical
  • Spondylosis, Cervical

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hard Cervical Collar — DEVICE
    Participants randomized to this arm will wear a hard cervical collar continuously for 6 weeks following posterior cervical fusion. The collar may be briefly removed for hygiene purposes. FDA-approved cervical collars (Aspen Cervical Collar, Aspen Vista Cervical Collar, or Miami J Cervical Collar) will be used according to institutional practice.

Study Details

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.

Key Dates

First listed
Aug 27, 2026
Start date
Jun 3, 2026
Status verified
Aug 2026
Primary completion
May 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Collar
    Hard Cervical Collar for 6 weeks
  • No Intervention: No collar

Primary Outcome Measure

Radiographic fusion success [ Time Frame: 3, 6, 12 months after surgery ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007
Amjad Anaizi, MD
[email protected]
301-856-2323
MedStar Washington Hospital CenterWashington D.C.District of Columbia22209
Amjad Anaizi, MD
[email protected]
301-856-2323

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By research site
MedStar Georgetown University Hospital· Washington D.C., DCMedStar Washington Hospital Center· Washington D.C., DC

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