跳至主要内容
临床试验/NCT07789288
NCT07789288招募中不适用

Impact of a Hard Cervical Collar Versus No Cervical Collar on Recovery Outcomes Following Posterior Cervical Fusion: A Prospective Study

Georgetown University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年6月3日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amjad Anaizi

Associate Professor of Neurosurgery at MedStar Georgetown University Hospital

Georgetown University

研究点 (2)

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