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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

NCT07755462 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-08-10

No results posted yet for this 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).

Conditions

  • Ankle Fractures
  • Osteoarthritis, Ankle

Interventions

PROCEDURE

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

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

PROCEDURE

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

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

Sponsors & Collaborators

  • Groupe Hospitalier Diaconesses Croix Saint-Simon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-22
Primary Completion
2028-09-30
Completion
2029-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07755462 on ClinicalTrials.gov