Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07481266
Eligibility Criteria:
Inclusion Criteria:
* Patients aged between 18 and 65 years.
* Diagnosis of an acute, closed, unstable rotational ankle fracture with concomitant involvement of the posterior malleolus and lateral malleolus (trimalleolar or bimalleolar equivalent fractures).
* Fracture morphology explicitly indicating surgical reduction and internal fixation via a posterolateral approach (e.g., Bartonicek Type II, III, or IV).
* Ability to provide informed consent and willingness to comply with the 12-month postoperative rehabilitation and follow-up protocol.
Exclusion Criteria:
* Open fractures, severe tibial pilon variants, or fractures with intra-articular comminution extending beyond the posterior malleolus.
* Persistent Syndesmotic Instability: Patients demonstrating persistent distal tibiofibular syndesmotic instability (confirmed by intraoperative hook test) after the fixation of the posterior and lateral malleoli, which inherently requires additional trans-syndesmotic fixation (e.g., syndesmotic screws or suture-button devices). This exclusion is strictly applied to eliminate methodological bias, as the experimental single-window approach intentionally restricts direct lateral access for trans-syndesmotic interventions.
* Delayed surgical intervention exceeding 7 days from the initial trauma, leading to organized hematoma or compromised soft-tissue envelopes.
* Pre-existing conditions detrimental to soft-tissue healing and functional assessment, including severe peripheral arterial disease, uncontrolled diabetes mellitus with neuropathy, or severe ipsilateral ankle osteoarthritis.
* Previous history of ipsilateral ankle fractures or surgeries.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07481266
Study Brief:
Protocol Section:
NCT07481266