A Prospective Randomized Controlled Trial of Dynamic Fixation for Complex Ankle Fractures With Syndesmotic Diastasis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- AOFAS（ Ankle-Hindfoot Score）
研究概览
简要总结
This prospective randomized controlled trial aims to evaluate the clinical effectiveness of dynamic fixation in patients with complex ankle fractures associated with syndesmotic diastasis.
Patients undergoing surgical treatment for complex ankle fractures with syndesmotic diastasis at Fujian Provincial Hospital Affiliated with Fuzhou University between October 2026 and October 2027 will be enrolled. Eligible participants will be randomly assigned in a 1:1 ratio to either the screw fixation (SF) group or the dynamic fixation (DF) group. All participants will be followed for 12 months after surgery. Clinical, functional, and radiographic outcomes will be compared between the two groups to assess the effectiveness and safety of dynamic fixation.
Statistical analyses will be performed using IBM SPSS Statistics version 27.0. The primary analysis will follow the intention-to-treat principle. Appropriate statistical methods will be selected according to the type and distribution of the data. Multivariable regression analyses will be performed when necessary to adjust for potential confounding factors. Missing data will be handled using multiple imputation where appropriate, and sensitivity analyses will be conducted to evaluate the robustness of the findings. All statistical tests will be two-sided, with a P<0.05 considered statistically significant.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-55 years;
- •Radiologically confirmed complex ankle fracture combined with distal tibiofibular syndesmosis separation;
- •First-time surgical treatment of the ankle;
- •Time from injury to surgery ≤ 2 weeks;
- •Able to comply with follow-up and sign a written informed consent;
- •Ankle function was basically normal before injury.
排除标准
- •1. Age <18 or >55;
- •Pathological fracture;
- •Previous ankle surgery or serious primary ankle disease;
- •Time from injury to surgery >2 weeks;
- •Active infection or serious medical condition;
- •Severe neurological or psychiatric disorder affecting follow-up compliance;
- •Postmenopausal women;
- •Other situations not suitable for enrollment
研究组 & 干预措施
the screw fixation group
干预措施: the screw fixation (Device)
the dynamic fixation group
干预措施: the dynamic fixation (Device)
结局指标
主要结局
AOFAS（ Ankle-Hindfoot Score）
时间窗: Preoperative; 1 week, 1 month, 3 months, 6 months, 1 year postoperative
次要结局
未报告次要终点
研究者
Zun Lin Cai
graduate student
Fuzhou University Affiliated Provincial Hospital