A Randomized Controlled Trial Evaluating the Stability of the Distal Tibiofibular Syndesmosis With or Without Fixation of the Posterior Fragments in Bimalleolar or Equivalent Fractures
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Rate of Intraoperative Trans-Syndesmotic Stabilization Device Use
研究概览
简要总结
Background and Rationale:
Injury to the tibiofibular syndesmosis in ankle fractures is a major prognostic factor for the development of post-traumatic osteoarthritis. The syndesmosis is frequently involved when posterior tibial marginal fragments are fractured. Intraoperative stability testing determines whether a trans-syndesmotic device (screws, endobutton, or plate) is required. However, trans-syndesmotic devices carry risks such as malreduction, hardware removal, and infection. Anatomical fixation of posterior tibial fragments is hypothesized to restore syndesmotic stability, thereby reducing the reliance on trans-syndesmotic implants. Objective and Hypothesis:
The primary objective of this randomized controlled trial is to compare the rate of trans-syndesmotic stabilization device usage between patients undergoing osteosynthesis of posterior marginal fragments and those managed without posterior fragment osteosynthesis. The hypothesis is that syndesmotic stability (defined as non-use of a trans-syndesmotic device intraoperatively) will be significantly higher in the posterior fragment fixation group. Study Design:
Multicenter, open-label, randomized, two-arm parallel-group trial conducted at two orthopedic trauma centers (Groupe Hospitalier Diaconesses Croix Saint-Simon and Hôpital Lariboisière).
详细描述
Study Flow and Procedures:
Screening and Randomization: Eligible patients presenting with recent bimalleolar ankle fractures (< 3 weeks) involving the posterior marginal fragment and syndesmosis (Bartoníček types 2, 3, or 4) are identified in the emergency/trauma department. Following written informed consent, participants are randomized into Group 1 (posterior marginal fragment osteosynthesis) or Group 2 (no posterior fragment osteosynthesis).
Preoperative Assessment: Comparative bilateral ankle X-rays and CT scans to confirm fracture classification and baseline metrics (fragment thickness > 2 mm, height > 6 mm).
Intraoperative Phase: Surgical management of the bimalleolar fracture according to assigned group. Intraoperative stress testing of the syndesmosis is performed to evaluate stability and record the necessity of trans-syndesmotic device placement.
Postoperative Follow-up: Day 1 to Week 6: Comparative bilateral CT scan to evaluate fragment and syndesmosis reduction. 3 Months & 12 Months: Clinical follow-up visits including comparative weight-bearing X-rays, evaluation of AOFAS score, and patient-reported questionnaires (MOXFQ, SF-12).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient informed and written consent obtained
- •Male or female participants aged 18 years or older
- •Recent first-time ankle fracture (< 3 weeks prior to inclusion) involving the posterior marginal fragment and syndesmosis (Bartoníček 2, 3, or 4) confirmed on preoperative CT scan
- •Fractured posterior marginal fragment with thickness > 2 mm and height > 6 mm in the sagittal plane on preoperative CT scan
排除标准
- •Medical contraindication to surgery as assessed by the investigator based on risk-benefit evaluation
- •High Tscherne grade soft-tissue injury score
- •Recent lower-extremity surgery within the past 3 months
- •Recurrent ankle fracture on the same side
- •Patient deprived of liberty by judicial or administrative order
- •Patient not affiliated with or beneficiary of a national social security scheme
- •Patient unable to understand spoken or written French
- •Patient whose geographical residence is incompatible with close in-person study follow-up
- •Adult patient unable or unfit to give informed consent
- •Woman of childbearing potential not using effective contraception
- •Pregnant or breastfeeding woman
研究组 & 干预措施
Group 1: with osteosynthesis of the posterior marginal fragments.
干预措施: Surgical management of bimalleolar ankle fractures with osteosynthesis of the posterior fragments. (Procedure)
Group 2: without osteosynthesis of the posterior marginal fragments
干预措施: Surgical management of bimalleolar ankle fractures without osteosynthesis of the posterior fragments (Procedure)
结局指标
主要结局
Rate of Intraoperative Trans-Syndesmotic Stabilization Device Use
时间窗: ntraoperative (Day 0)
Proportion of patients requiring the intraoperative placement of a trans-syndesmotic stabilization device (such as a screw, endobutton, or plate) to achieve syndesmotic stability, as assessed during surgery following stress testing.
次要结局
- American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score(3 months and 12 months postoperatively)
- Manchester-Oxford Foot Questionnaire (MOXFQ) Total Score(3 months and 12 months postoperatively)
- Short Form-12 (SF-12) Physical and Mental Component Summary Scores(3 months and 12 months postoperatively)
- Incidence of Postoperative Complications(Through 12 months postoperatively)
- Radiographic Parameters of Syndesmosis Alignment on Weight-Bearing X-rays(3 months and 12 months postoperatively)
- Postoperative Posterior Marginal Fragment and Syndesmosis Anatomical Alignment by CT Scann(Between Postoperative Day 1 and Week 6)