Ankle FracturesSYNDESMOSENCT07755462
Stability of Distal Tibiofibular Syndesmosis With or Without Fixation of Posterior Fragments in Bimalleolar Fractures
A study testing 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 people with Ankle Fractures and Osteoarthritis, Ankle, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Fractures, Osteoarthritis, Ankle
- What is being tested?
- 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
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 22 Sep 2025to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe hospitalier Diaconesses Croix Saint Simon
Paris, Paris, 75020
About this study
Official title: 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
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:
Read more
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).
Read the detailed description
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.
- Conditions
- Ankle Fractures, Osteoarthritis, Ankle
- Being tested
- Surgical management of bimalleolar ankle fractures with osteosynthesis of the posterior fragments., Surgical management of bimalleolar ankle fractures without osteosynthesis of the posterior fragments
- Keywords
- Tibiofibular Syndesmosis, Bimalleolar Fracture, Posterior Marginal Fragment, Trans-syndesmotic Fixation, Bartoníček Classification
- Medical subject headings
- Ankle Fractures, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical management of bimalleolar ankle fractures with osteosynthesis of the posterior fragments.Procedure or surgery
Surgical management of bimalleolar ankle fractures with osteosynthesis of the posterior fragments
Surgical management of bimalleolar ankle fractures without osteosynthesis of the posterior fragmentsProcedure or surgery
Surgical management of bimalleolar ankle fractures without osteosynthesis of the posterior fragments.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: with osteosynthesis of the posterior marginal fragments. | Active comparator | Not described Receives: Procedure: Surgical management of bimalleolar ankle fractures with osteosynthesis of the posterior fragments. |
| Group 2: without osteosynthesis of the posterior marginal fragments | Active comparator | Not described Receives: Procedure: Surgical management of bimalleolar ankle fractures without osteosynthesis of the posterior fragments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ntraoperative (Day 0)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start22 Sep 2025
- Primary completionSep 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755462
- Sponsor's protocol ID
- GHDCSS_RIPH1_ORTHO_2024
- Acronym
- SYNDESMOSE
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31594732Ray 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.
PubMed 29409288Pogliacomi 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.
PubMed 34055585van 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.
PubMed 22474636
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07755462
- Acronym / sponsor ID
- SYNDESMOSE / GHDCSS_RIPH1_ORTHO_2024
- Conditions
- Ankle Fractures, Osteoarthritis, Ankle
- Keywords
- Tibiofibular Syndesmosis, Bimalleolar Fracture, Posterior Marginal Fragment, Trans-syndesmotic Fixation, Bartoníček Classification
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-SimonUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Group 1: with osteosynthesis of the posterior marginal fragments. |
| Surgical management of bimalleolar ankle fractures without osteosynthesis of the posterior fragmentsSurgical management of bimalleolar ankle fractures without osteosynthesis of the posterior fragments. | Procedure or surgery | Group 2: without osteosynthesis of the posterior marginal fragments |
Primary outcome
Rate of Intraoperative Trans-Syndesmotic Stabilization Device Use
Time frame: 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.
6 secondary outcomes
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score
Time frame: 3 months and 12 months postoperatively
Manchester-Oxford Foot Questionnaire (MOXFQ) Total Score
Time frame: 3 months and 12 months postoperatively
Short Form-12 (SF-12) Physical and Mental Component Summary Scores
Time frame: 3 months and 12 months postoperatively
Postoperative Posterior Marginal Fragment and Syndesmosis Anatomical Alignment by CT Scann
Time frame: Between Postoperative Day 1 and Week 6
Radiographic Parameters of Syndesmosis Alignment on Weight-Bearing X-rays
Time frame: 3 months and 12 months postoperatively
Incidence of Postoperative Complications
Time frame: Through 12 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Background: PubMed 31594732Tourne 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.
- Background: PubMed 29409288Ray 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.
- Background: PubMed 34055585Pogliacomi 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.
- Background: PubMed 22474636van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Ankle Fractures and Osteoarthritis, Ankle, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Intraoperative Trans-Syndesmotic Stabilization Device Use (time frame: ntraoperative (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07755462, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.