Ankle Fractures, Osteoarthritis, Ankle
Conditions
Keywords
Tibiofibular Syndesmosis, Bimalleolar Fracture, Posterior Marginal Fragment, Trans-syndesmotic Fixation, Bartoníček Classification
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).
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.
Interventions
PROCEDURESurgical management of bimalleolar ankle fractures with osteosynthesis of the posterior fragments.
Surgical management of bimalleolar ankle fractures with osteosynthesis of the posterior fragments
PROCEDURESurgical management of bimalleolar ankle fractures without osteosynthesis of the posterior fragments
Surgical management of bimalleolar ankle fractures without osteosynthesis of the posterior fragments.
Sponsors
Groupe Hospitalier Diaconesses Croix Saint-Simon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Form-12 (SF-12) Physical and Mental Component Summary Scores | 3 months and 12 months postoperatively | 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. |
| Manchester-Oxford Foot Questionnaire (MOXFQ) Total Score | 3 months and 12 months postoperatively | 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. |
| Postoperative Posterior Marginal Fragment and Syndesmosis Anatomical Alignment by CT Scann | Between Postoperative Day 1 and Week 6 | 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. |
| Radiographic Parameters of Syndesmosis Alignment on Weight-Bearing X-rays | 3 months and 12 months postoperatively | 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. |
| Incidence of Postoperative Complications | Through 12 months postoperatively | Proportion of patients experiencing surgery-related complications, including surgical site infections, neuropathic pain, fibular pain, or flexor hallucis longus pain. |
| American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score | 3 months and 12 months postoperatively | 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. |
Countries
France
Outcome results
None listed