Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury. Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 4
- 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
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 Tightrope Syndesmosis Repair Kit (Arthrex; Naples, Florida). is used for the same indication, it consists of a heavy suture placed across the syndesmosis which has been looped and tightened through cortical button anchors on either side of the ankle. It does not need removal and thus avoids subsequent surgery. This trial compares these two treatment methods for syndesmotic injuries of the ankle.
详细描述
Patients 18-70 years presenting to one of the two hospitals with an acute syndesmotic injury are eligible for inclusion. 50 patients are randomised to two treatment groups: One group receives a Tightrope (R) fixation and the other receives a quadricortical screw fixation which is removed after 12 weeks. Follow-up intervals are at 6 weeks, 6, 12 and 24 months with standardised CT scans postoperatively and at 12, 24 months and 5 years clinical end-ponts/scores.
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 or without Weber type C fracture
排除标准
- •Prior injury of the same ankle
- •Severe injury of same leg affecting rehabilitation
- •Symptomatic osteoarthritis of same ankle
- •Open injury
- •Decubital injury affecting surgical site
- •Dementia or unable to sign informed consent
- •Neuropathic conditions affecting same leg
研究组 & 干预措施
Tightrope
Treatment with Tightrope Syndesmosis Repair Kit
干预措施: Tightrope Syndesmosis Repair Kit (Device)
Syndesmotic screw
Treatment with a quadricortical syndesmotic screw
干预措施: Syndesmotic screw (Device)
结局指标
主要结局
OTA Score (Modified American Orthopaedic Foot and Ankle Society ankle hind foot score)
时间窗: 5 years
Modified American Orthopaedic Foot and Ankle Society ankle hind foot score (0-100)
次要结局
- Olerud-Molander Ankle (OMA) Score(5 years)
- Health-related quality of life (EQ-5D)(5 years)
- Dorsiflexion angle(5 years)
- CT measurements of syndesmotic distance(5 years)
研究者
Wender Figved
MD PhD
Sykehuset Asker og Baerum