Recruiting

Cervical Collar

Sponsor:

Georgetown University

Code:

NCT07789288

Conditions

Spinal Stenosis Cervical

Radiculopathy, Cervical Region

Posterior Cervical Fusion

Spondylosis, Cervical

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hard Cervical Collar

Study Details

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.

Conditions

Spinal Stenosis Cervical

Radiculopathy, Cervical Region

Posterior Cervical Fusion

Spondylosis, Cervical

Study ID

NCT07789288

Start date

Jun 3, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Collar

Hard Cervical Collar for 6 weeks

no intervention: No collar

Interventions

Hard Cervical Collar

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

MedStar Georgetown University Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 22209

Contacts

More Information

Sponsor

Georgetown University

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgetown University on 2026-08-27.