An interventional study of Surgical management of bimalleolar ankle fractures with osteosynthesis of the posterior fragments. and Surgical management of bimalleolar ankle fractures without osteosynthesis of the posterior fragments in Ankle Fractures and Osteoarthritis, Ankle, sponsored by Groupe Hospitalier Diaconesses Croix Saint-Simon. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Groupe Hospitalier Diaconesses Croix Saint-Simon · Not applicable, Interventional, and Other
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).
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).
Postoperative complications (infections, neuropathic pain, fibular pain, flexor hallucis longus tendonitis) are systematically recorded throughout the 12-month follow-up.
202 studies on the registry are indexed under Ankle Fractures; 44 are open to participants now.
This study's planned enrollment of 150 is above the median of 90 across 150 interventional studies indexed under Ankle Fractures.
Browse Ankle Fractures studies →Groupe Hospitalier Diaconesses Croix Saint-Simon is the lead sponsor of 27 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: 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 with osteosynthesis of the posterior fragments
Surgical management of bimalleolar ankle fractures without osteosynthesis of the posterior fragments.
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.
Time frame: ntraoperative (Day 0)
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score
Clinical and functional assessment score combining pain, function, and alignment. The total score ranges from 0 to 100 points, where 0 represents severe disability/pain and 100 represents optimal function and no pain. Higher scores indicate better clinical outcome.
Time frame: 3 months and 12 months postoperatively
Manchester-Oxford Foot Questionnaire (MOXFQ) Total Score
Patient-reported outcome measure assessing foot/ankle pain, walking/standing difficulties, and social interaction. The metric is converted to a score ranging from 0 to 100, where 0 represents no symptoms/best health state and 100 represents severe impairment. Higher scores indicate worse symptoms.
Time frame: 3 months and 12 months postoperatively
Short Form-12 (SF-12) Physical and Mental Component Summary Scores
Patient-reported general health survey generating a Physical Component Summary (PCS) and Mental Component Summary (MCS) score. Norm-based scores range from 0 to 100, where higher scores indicate better health status.
Time frame: 3 months and 12 months postoperatively
Postoperative Posterior Marginal Fragment and Syndesmosis Anatomical Alignment by CT Scann
Assessment of posterior marginal fragment and syndesmosis anatomical alignment (measuring fibular rotation, anterior and posterior tibiofibular distances, and anteroposterior translation) evaluated on postoperative CT scans.
Time frame: Between Postoperative Day 1 and Week 6
Radiographic Parameters of Syndesmosis Alignment on Weight-Bearing X-rays
Radiographic assessment of syndesmotic anatomical alignment and joint space congruence on weight-bearing comparative X-rays, including medial clear space, tibiofibular clear space, tibiofibular overlap, and fibular length.
Time frame: 3 months and 12 months postoperatively
Incidence of Postoperative Complications
Proportion of patients experiencing surgery-related complications, including surgical site infections, neuropathic pain, fibular pain, or flexor hallucis longus pain.
Time frame: Through 12 months postoperatively
Plan to share: No
Started Sep 2025 (actual). Primary completion is estimated for Sep 2028, 36 months after the start.
Of 69 non-industry interventional studies with no phase under Ankle Fractures, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 61. This study's planned 36 months is below that.
Counting every sponsor, half of 72 studies reached it within 45 months; a quarter within 23 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Groupe Hospitalier Diaconesses Croix Saint-Simon