Anterior Cervical Spine Strap Muscle Splitting Versus Smith-Robinson Approach: A Single-Centre Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Dysphagia as per the HSS-DDI
研究概览
简要总结
Anterior cervical spine surgery (ACSS) is a procedure for the treatment of several neck problems. Even though the procedure is overall safe and effective, there are possible complications after surgery, which include problems swallowing, hoarseness of the voice, and pain when swallowing.
There are two different ways the spinal surgeon can approach the spine from the front of the neck. One is called a Smith-Robinson approach, and the other is called a strap-splitting approach. Each approach uses the same skin cut, the difference is only in how the next layer is approached, whether on the outside (Smith-Robinson) or through (strap-splitting) one of the small muscles in your neck. Because of the slightly different approaches to the surgery, we want to see if there are differences in complications related to swallowing and speaking between these two approaches.
Participants will undergo one of the two surgical approaches, based on surgeon preference. Participants will complete a questionnaire at several time points during their clinical follow-up to assess any difficulties swallowing and speaking.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Adult patients (18 years of age or older).
- •Patients undergoing anterior cervical spine surgery including Anterior cervical discectomy and fusion (ACDF), Anterior cervical arthroplasty (ACA) and Anterior cervical corpectomy and fusion (ACCF)
- •Ability to complete HSS-DDI questionnaire in English
排除标准
- •Planned use of anterior odontoid screws
- •Revision anterior surgery
- •Trauma patient
研究组 & 干预措施
Standard Smith-Robinson
Approach with incision between the strap muscles and the sternocleidomastoid
Strap-splitting
Approach with incision splitting the infrahyoid strap muscles
结局指标
主要结局
Dysphagia as per the HSS-DDI
时间窗: 6 weeks post-operative
次要结局
- Injury to vital neurovascular structures(Time of surgery)
- Length of intraoperative time in minutes, adjusting for surgeon, surgical type, and number of levels(Time of surgery)
- Dysphagia as measured by the HSS-DDI(post-operative day 1, 6 months, and 12 months)
- Changes in voice as measured by the HSS-DDI(Post-operative day 1, 6 weeks, 6 months, and 12 months)
- Blood loss during surgery measured in mL(Time of surgery)