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

Recruiting now · Not applicable

Conditions studied: Ankle Fractures, Posterior Malleolus Fractures, Lateral Malleolus Fracture

In brief

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.

Key facts

Study ID

NCT07481266

Run by

muhammed kılıç

People needed

100

Starts

2024-02-14

Expected to finish

2027-03-01

Last updated by the study team

2026-03-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ankara Bilkent City Hospital — Ankara, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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