Randomized Controlled Trial Comparing Clinical Outcomes of Patients Treated Surgically With Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Foot and Ankle Disability Index
研究概览
简要总结
This project consists of a randomized controlled study design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have an acute ankle syndesmosis injury requiring surgery. Patients who consent to study participation will be randomized to receive one of two standard of care procedures - either a suture button or Fibulink implant. Outcome measures, including the Olerud-Molander and American Orthopaedic Foot and Ankle Society scores, pain, range of motion, time to return to work, and radiographic evaluation will be collected for each participant. Given the potential degenerative changes and poor radiographic and clinical outcomes with inadequate repair of the syndesmosis, it is imperative to evaluate existing and emerging methods of fixation for patients with acute ankle fractures with syndesmosis injuries.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ankle fracture with associated syndesmotic injury requiring surgery
- •Age 18 years or older
- •Ability to understand the content of the patient information/informed consent form
排除标准
- •Any not medically managed severe systemic disease
- •Patient preference for specific implant
- •Refusal of randomization
- •Pregnant patients
- •Prisoners
- •Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study
研究组 & 干预措施
Arthrex Tightrope
Syndesmosis fixation performed with ARthrex Tightrope device. This is a high-tension suture fixation with a button based anchor system.
干预措施: Arthrex Tightrope (Device)
Synthes Fibulink
Syndesmosis fixation perforemd with Synthes Fibulink device. This is a high-tension fixation with a screw based anchor system.
干预措施: Synthes Fibulink (Device)
结局指标
主要结局
Foot and Ankle Disability Index
时间窗: 1 year
Functional score with a 0-104 with higher scores indicating better function
Visual Analog Scale (VAS) Pain score
时间窗: 1 year
VAS Pain score is rated from 0-10, 0=no pain and 10=most severe pain
Olerud-Molander Ankle Score
时间窗: 1 year
Functional Score with a score of 0-100 with higher scores indicating better function
次要结局
- Number of participants with medical or surgical complications(1 year)
研究者
William Kent
Assistant Professor of Orthopaedic Surgery
University of California, San Diego
