The Collar Post Anterior Cervical Spine Surgery (C-PASS) Study: Project Proposal for a Multi-Center Randomized Trial Evaluating the Impact of Post-Operative Bracing on Clinical Outcomes After Anterior Cervical Discectomy and Fusion.
试验速览
- 阶段
- 不适用
- 入组人数
- 244
- 试验地点
- 4
- 主要终点
- Neck Disability index
研究概览
简要总结
The Anterior Cervical Discectomy and Fusion (ACDF) represents one of the most commonly performed spinal operations internationally, often in the context of symptomatic radiculopathy or myelopathy secondary to cervical degenerative disease. Approximately half of surgeons continue to prescribe a period of post-operative bracing with a cervical collar. However, there is currently no high quality evidence available to support the routine use of post-operative bracing after ACDF; further, braces are expensive and have been associated with a variety of local complications. In summary, the current lack of evidence, and lack of consensus amongst surgeons, regarding best practices in the use of post-operative bracing after ACDF, places the surgeon and the patient in a precarious position.
Our randomized trial comparing the impact of 6 weeks of post-operative bracing with a rigid cervical collar vs. no post-operative bracing, on a variety of clinical and radiological outcomes, for adult patients with cervical radiculopathy and/or myelopathy undergoing single or multi-level ACDF.
详细描述
The Anterior Cervical Discectomy and Fusion (ACDF) represents one of the most commonly performed spinal operations internationally, often in the context of symptomatic radiculopathy or myelopathy secondary to cervical degenerative disease. Approximately half of surgeons continue to prescribe a period of post-operative bracing with a cervical collar. However, there is currently no high quality evidence available to support the routine use of post-operative bracing after ACDF; further, braces are expensive and have been associated with a variety of local complications. In summary, the current lack of evidence, and lack of consensus amongst surgeons, regarding best practices in the use of post-operative bracing after ACDF, places the surgeon and the patient in a precarious position.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between the ages of 18 and 80;
- •presenting with cervical radiculopathy and/or myelopathy to one of the study centers;
- •deemed appropriate by the attending surgeon involved for a one, two or three level plated ACDF or a one-level ACDF with a standalone interbody cage; and
- •able to cooperate in the completion of all study consents, forms and documents.
- •Participants who are able to speak, read and write at an elementary school level
排除标准
- •those with previous cervical surgery;
- •those undergoing single or multi-level plated ACDF for a diagnosis related to malignancy, infection or trauma;
- •those undergoing a single or multi-level plated ACDF augmented with a posterior cervical fusion or posterior cervical decompression and fusion;
- •those undergoing a multi-level non-plated ACDF;
- •those undergoing ACDF at greater than three levels, and;
- •those with a pre-existent neurological or mental disorder which would preclude accurate evaluation and follow-up.
研究组 & 干预措施
No post-operative bracing
patients in this arm will not be prescribed a cervical collar following anterior cervical discectomy and fusion surgery
Post-operative bracing
Patients in this arm will be prescribed a cervical collar following anterior cervical discectomy and fusion surgery.
干预措施: Cervical collar (Device)
结局指标
主要结局
Neck Disability index
时间窗: 6 month
This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life.
次要结局
- EQ-5D(3, 6, 12 month)
- Visual analog score(3, 6, 12 month)
- Neck Disability Index(3 and 12 month)
- Plain Xray Radiography(6 week, 12 month)