Ziptight or Tricortical Screw Fixation of Acute Tibiofibular Syndesmotic Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- OTA Score (Modified American Orthopaedic Foot and Ankle Society ankle hind foot score)
研究概览
简要总结
Treatment of syndesmotic injury with Weber C fracture. A randomized study comparing ZipTight suture endobutton and one tricortical 3,5 mm syndesmotic screw.
详细描述
Syndesmotic injuries are common and often associated with unstable ankle fractures. The most common treatment is with a syndesmotic screw through the fibula and tibia which is later removed, usually after 10-12 weeks. The ZipTight suture endobutton (Biomet) is used for the same indication. It does not need removal and thus avoids subsequent surgery. This trial will compare these two methods and see if they are equal.
patients 18-70 years presenting to one of the three hospitals with and acute syndesmotic injury are eligible for inclusion. 120 patients are randomized to two treatment groups. One group will be treated with a ZipTight suture endobutton fixation and the other receives a tricortical screw fixation. Neither suture endobutton or screw is routinely removed. Follow up intervals are at 6 weeks, 6, 12 and 24 months with clinical and-points. Standardized CT scans are taken postoperatively and at 12 and 24 months.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 70 years
- •Acute syndesmotic injury with Weber type C fracture
排除标准
- •Prior injury og the same ankle
- •Severe injury of the same leg affecting rehabilitation
- •Symptomatic osteoarthritis of same ankle
- •open injury
- •Decubital injury affecting surgical site
- •Dementia or unable to sign informed consent
- •neuropatic conditions affecting same leg
结局指标
主要结局
OTA Score (Modified American Orthopaedic Foot and Ankle Society ankle hind foot score)
时间窗: 24 months
Modified American Orthopaedic Foot and Ankle Society ankle hind foot score (0-100)
次要结局
- Health-related quality of life (EQ-5D)(24 months)
- Manchester-Oxford Foot questionnaire (MOxFQ)(24 months)
- VAS(24 months)
- Dorsiflexion angle(24 months)
- CT measurements of syndesmotic distance(24 months)