Single-Window Versus Two-Window Posterolateral Approach for Malleolar Fractures
Comparison of Single-Window and Two-Window Posterolateral Approaches in Posterior and Lateral Malleolus Fractures: A Clinical Outcomes Analysis
muhammed kılıç
100 participants
Feb 14, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria5
- 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.
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Interventions
Fixation of the fibular fracture utilizing a posterior antiglide plate configuration applied directly to the posterior surface of the fibula.
Fixation of the fibular fracture utilizing a standard lateral anatomic plate configuration applied to the lateral surface of the fibula.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07481266