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

Running, not enrolling · Not applicable

Conditions studied: Ankle Fractures, Osteoarthritis, Ankle

In brief

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).

Key facts

Study ID

NCT07755462

Run by

Groupe Hospitalier Diaconesses Croix Saint-Simon

People needed

150

Starts

2025-09-22

Expected to finish

2029-09-01

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Groupe hospitalier Diaconesses Croix Saint Simon — Paris, Paris, France

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.