Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

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

Recruiting Locations

MedStar Georgetown University Hospital
Washington D.C., District of Columbia 20007
Contact:
Amjad Anaizi, MD
301-856-2323
Amjad.N.Anaizi@gunet.georgetown.edu

MedStar Washington Hospital Center
Washington D.C., District of Columbia 22209
Contact:
Amjad Anaizi, MD
301-856-2323
Amjad.N.Anaizi@gunet.georgetown.edu

More Details

Status
Recruiting
Sponsor
Georgetown University

Study Contact

Amjad Anaizi, MD
301-856-2323
Amjad.N.Anaizi@gunet.georgetown.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.