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Clinical Trials in Turkey / NCT07481266
Recruiting Not applicable

Single-Window Versus Two-Window Posterolateral Approach for Malleolar Fractures

NCT07481266 · tracked via the Priya Life Science Turkey tracker
Sponsor
muhammed kılıç
Phase
Not applicable
Started
2024-02-14
Last updated
2026-03-20

Condition(s) studied

Ankle FracturesPosterior Malleolus FracturesLateral Malleolus Fracture

Investigational drug(s) / intervention(s)

Posterior Antiglide PlatingLateral Anatomic Plating

Posterior Antiglide Plating: Fixation of the fibular fracture utilizing a posterior antiglide plate configuration applied directly to the posterior surface of the fibula.

Lateral Anatomic Plating: Fixation of the fibular fracture utilizing a standard lateral anatomic plate configuration applied to the lateral surface of the fibula.

Study summary

The purpose of this prospective clinical trial is to compare the clinical outcomes and early wound complication rates of two different surgical techniques used during the posterolateral approach for ankle fractures. Participants with fractures involving the posterior and lateral malleoli will undergo surgery using either a single-window technique (using a posterior antiglide plate) or a two-window technique (using a lateral anatomic plate). The main question the study aims to answer is whether the single-window approach reduces soft-tissue complications by minimizing surgical dissection, without compromising fracture stability. Patients will be followed for 12 months to assess wound healing, ankle range of motion, implant irritation, and functional recovery.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ankara Bilkent City Hospital Ankara Turkey (Türkiye) Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07481266 on ClinicalTrials.gov ↗ ← All trials in Turkey