Posterior Cervical Fusion, Radiculopathy, Cervical Region, Spinal Stenosis Cervical, Spondylosis, Cervical
Conditions
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.
Interventions
DEVICEHard 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.
Sponsors
Georgetown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic fusion success | 3, 6, 12 months after surgery | Fusion success following posterior cervical fusion as determined by blinded radiographic evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neck Disability Index (NDI) | Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months after surgery | Patient-reported neck disability measured using the Neck Disability Index survey |
| EQ-5D Quality of Life | Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months | Patient-reported survey |
| Numeric Rating Scale (NRS) for Neck Pain | Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months | Patient-reported survey |
| Numeric Rating Scale (NRS) for Arm Pain | Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months | Patient-reported survey |
| North American Spine Society (NASS) Patient Satisfaction Index | 6 weeks, 12 weeks, 6 months, and 12 months | Patient-reported survey |
| Wound infection rate | up to 12 months after surgery | — |
Countries
United States
Contacts
CONTACTAmjad Anaizi, MD
Outcome results
None listed