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.
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
None
Parallel
Hard Cervical Collar
DeviceParticipants 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.
Radiographic fusion success
Fusion success following posterior cervical fusion as determined by blinded radiographic evaluation
Neck Disability Index
Patient-reported neck disability measured using the Neck Disability Index (NDI). Scores range from 0 to 50, with higher scores indicating greater neck-related disability.
EQ-5D-3L Quality of Life
Patient-reported health-related quality of life measured using the EQ-5D-3L descriptive system and EQ visual analogue scale (EQ VAS). The EQ-5D-3L assesses five dimensions of health, each with three levels of severity. The EQ VAS ranges from 0 to 100, with higher scores indicating better self-rated health.
Numeric Rating Scale for Neck Pain
Patient-reported neck pain severity measured using the Numeric Rating Scale (NRS). Scores range from 0 to 10, with higher scores indicating greater pain severity.
Numeric Rating Scale for Arm Pain
Patient-reported arm pain severity measured using the Numeric Rating Scale (NRS). Scores range from 0 to 10, with higher scores indicating greater pain severity.
Click on the lead sponsor to view all of their trials.
