Prospective Randomized Multicentric Trial Comparing a Static Implant and a Dynamic Implant in the Surgical Treatment of Ankle Syndesmosis Rupture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Olerud-Molander score
研究概览
简要总结
Ankle fracture is frequent and its number is increasing. In Canada, surgical treatment of these lesions is advised and the options currently used all have in common a rigid fixation of the syndesmosis which results in residual stiffness and a high level of secondary surgery, mostly to remove the implant.
The purpose of the study is to compare the treatment of ankle syndesmotic rupture by a dynamic fixation to a static fixation suggesting that the dynamic fixation method will improve the Olerud-Molander functional score of more than 15 points at the 3 months follow-up.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men or women ≥ 18 years-old;
- •ankle fracture type 44-C (AO classification) with an AP, lateral and mortise X-ray views of the ankle and an AP and lateral X-ray views of the leg;
- •open fractures (Gustilo I-IIIb) or closed;
- •trauma-surgery delay of less than 7 days;
- •consent form signed.
排除标准
- •ankle fractures without syndesmotic lesion;
- •fracture associated with neuro-vascular lesions (Gustillo IIIc);
- •pathologic fracture;
- •fracture in a polytraumatized patient;
- •fracture of a bone in the ipsilateral leg;
- •men or women > 65 years-old;
- •chronic cardiac insufficiency (ejection fraction < 30%);
- •lower leg chronic venous insufficiency;
- •neuro-arthropathic foot (Charcot, diabetes, etc...);
- •body mass index ≥ 40;
- •past medical history of fracture of the same ankle;
- •medical conditions too serious for a surgery;
- •men or women unfit to consent;
- •any other conditions that make the examinator thinks that the follow up would be problematic.
结局指标
主要结局
Olerud-Molander score
时间窗: 3 months after surgery
The Olerud-Molander scoring scale was chosen because it adequately represents the ankle performance following surgery (trauma or elective basis). It comprises nine functional parameters which are concerned with primary complaints, the ability to perform simple tasks and the everyday life activities.
次要结局
- Rate of secondary surgery(within one year following surgery)
- Radiological loss of reduction(12 months after surgery)
- Implant failure(one year after surgery)
- American Orthopaedic Foot and Ankle Society (AOFAS) score of hindfoot(12 weeks after surgery)
- AOFAS score of hindfoot(12 months after surgery)
- Return to professional activities(3 months after surgery)
- Pain on visual analog scale (VAS)(12 weeks after surgery)
- Pain on VAS(12 months after surgery)
- Range of motion(12 months after surgery)
- Muscular trophicity measure of the leg(12 months after surgery)
- Ankle circumference measure(12 months after surgery)
研究者
Pelet Stephane
Dr Stephane Pelet MD, PhD Orthopedic surgeon
Hopital de l'Enfant-Jesus