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 | Active Not Recruiting

• 1 other identifier: GHDCSS_RIPH1_ORTHO_2024
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tibiofibular Syndesmosis; Bimalleolar Fracture; Posterior Marginal Fragment; Trans-syndesmotic Fixation; Bartoníček Classification

Outcome Measures

Primary Outcomes (1)

• Rate of Intraoperative Trans-Syndesmotic Stabilization Device Use

  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.

  ntraoperative (Day 0)

Secondary Outcomes (6)

• 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

• Postoperative Posterior Marginal Fragment and Syndesmosis Reduction Quality by CT Scan

  Between Postoperative Day 1 and Week 6

• Radiographic Parameters of Syndesmosis Alignment on Weight-Bearing X-rays

  3 months and 12 months postoperatively

Study Arms (2)

Group 1: with osteosynthesis of the posterior marginal fragments.

ACTIVE COMPARATOR

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

Group 2: without osteosynthesis of the posterior marginal fragments

ACTIVE COMPARATOR

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

Interventions

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

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

Group 1: with osteosynthesis of the posterior marginal fragments.

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

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

Group 2: without osteosynthesis of the posterior marginal fragments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient informed and written consent obtained
• Male or female participants aged 18 years or older
• 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

Sponsors & Collaborators

• Groupe Hospitalier Diaconesses Croix Saint-Simon: lead

Study Sites (1)

Groupe hospitalier Diaconesses Croix Saint Simon

Paris, Paris, 75020, France

Location

Related Publications (4)

• Tourne Y, Molinier F, Andrieu M, Porta J, Barbier G. Diagnosis and treatment of tibiofibular syndesmosis lesions. Orthop Traumatol Surg Res. 2019 Dec;105(8S):S275-S286. doi: 10.1016/j.otsr.2019.09.014. Epub 2019 Oct 5.

  PMID: 31594732 BACKGROUND

• Ray R, Koohnejad N, Clement ND, Keenan GF. Ankle fractures with syndesmotic stabilisation are associated with a high rate of secondary osteoarthritis. Foot Ankle Surg. 2019 Apr;25(2):180-185. doi: 10.1016/j.fas.2017.10.005. Epub 2017 Oct 28.

  PMID: 29409288 BACKGROUND

• Pogliacomi F, De Filippo M, Casalini D, Longhi A, Tacci F, Perotta R, Pagnini F, Tocco S, Ceccarelli F. Acute syndesmotic injuries in ankle fractures: From diagnosis to treatment and current concepts. World J Orthop. 2021 May 18;12(5):270-291. doi: 10.5312/wjo.v12.i5.270. eCollection 2021 May 18.

  PMID: 34055585 BACKGROUND

• van den Bekerom MP. Diagnosing syndesmotic instability in ankle fractures. World J Orthop. 2011 Jul 18;2(7):51-6. doi: 10.5312/wjo.v2.i7.51.

  PMID: 22474636 BACKGROUND

MeSH Terms

Conditions

Ankle Fractures; Osteoarthritis

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start: September 22, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)