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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
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.
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
RECRUITINGMedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
RECRUITINGRadiographic fusion success
Fusion success following posterior cervical fusion as determined by blinded radiographic evaluation
Time frame: 3, 6, 12 months after surgery
Neck Disability Index (NDI)
Patient-reported neck disability measured using the Neck Disability Index survey
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months after surgery
EQ-5D Quality of Life
Patient-reported survey
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months
Numeric Rating Scale (NRS) for Neck Pain
Patient-reported survey
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months
Numeric Rating Scale (NRS) for Arm Pain
Patient-reported survey
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months
North American Spine Society (NASS) Patient Satisfaction Index
Patient-reported survey
Time frame: 6 weeks, 12 weeks, 6 months, and 12 months
Wound infection rate
Time frame: up to 12 months after surgery
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