Health TrialsbyHealthPanel

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

ConditionsAnkle FracturesPosterior Malleolus FracturesLateral Malleolus Fracture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
Sponsormuhammed kılıç

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Posterior Antiglide Plating

    Procedure/Surgery

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

  • Lateral Anatomic Plating

    Procedure/Surgery

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Single-Window Approach (Posterior Antiglide Plate)Experimental treatment 1 intervention
Group B: Two-Window Approach (Lateral Anatomic Plate)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Wound Complications

The total number of participants experiencing any early postoperative wound complications at the surgical site. This includes wound dehiscence, superficial or deep surgical site infection, wound edge necrosis, and delayed wound healing.

Time frame
Up to 3 months postoperatively

Secondary outcomes

1

American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score

Functional outcome will be evaluated using the AOFAS ankle-hindfoot scale. The total score ranges from 0 to 100, with higher scores indicating better functional recovery.

Time frame
6 and 12 months postoperatively
2

Ankle Range of Motion (ROM)

Objective measurement of the ankle joint's maximal plantarflexion and dorsiflexion angles in degrees, assessed using a standard clinical goniometer.

Time frame
12 months postoperatively
3

Visual Analog Scale (VAS) for Pain

Asessment of patient-reported pain intensity during weight-bearing. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.

Time frame
6 and 12 months postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

muhammed kılıç

Lead sponsor

Ankara City Hospital Bilkent

Sponsor institution

Source ClinicalTrials.gov
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