Impact of a Hard Cervical Collar Versus No Cervical Collar on Recovery Outcomes Following Posterior Cervical Fusion: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Radiographic fusion success
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- Patients with trauma, tumors, or infections
结局指标
主要结局
Radiographic fusion success
时间窗: 3, 6, 12 months after surgery
Fusion success following posterior cervical fusion as determined by blinded radiographic evaluation
次要结局
- Wound infection rate(up to 12 months after surgery)
- Numeric Rating Scale (NRS) for Arm Pain(Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months)
- North American Spine Society (NASS) Patient Satisfaction Index(6 weeks, 12 weeks, 6 months, and 12 months)
- Neck Disability Index (NDI)(Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months after surgery)
- EQ-5D Quality of Life(Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months)
- Numeric Rating Scale (NRS) for Neck Pain(Baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months)
研究者
Amjad Anaizi
Associate Professor of Neurosurgery at MedStar Georgetown University Hospital
Georgetown University
