Stability of Distal Tibiofibular Syndesmosis With or Without Fixation of Posterior Fragments in Bimalleolar Fractures

NCT07755462 · tracked via the Priya Life Science France tracker

Sponsor

Groupe Hospitalier Diaconesses Croix Saint-Simon

Phase

Not applicable

Started

2025-09-22

Last updated

2026-08-26

Condition(s) studied

Ankle FracturesOsteoarthritis, Ankle

Investigational drug(s) / intervention(s)

Surgical management of bimalleolar ankle fractures with osteosynthesis of the posterior fragments.Surgical management of bimalleolar ankle fractures without osteosynthesis of the posterior fragments

Surgical management of bimalleolar ankle fractures with osteosynthesis of the posterior fragments.: Surgical management of bimalleolar ankle fractures with osteosynthesis of the posterior fragments

Surgical management of bimalleolar ankle fractures without osteosynthesis of the posterior fragments: Surgical management of bimalleolar ankle fractures without osteosynthesis of the posterior fragments.

Study summary

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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Rate of Intraoperative Trans-Syndesmotic Stabilization Device Use — 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.

Trial sites (1)

Facility	City	Region	Status
Groupe hospitalier Diaconesses Croix Saint Simon	Paris	Paris

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07755462 on ClinicalTrials.gov ↗ ← All trials in France