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

March 18, 2026 updated by: muhammed kılıç

Comparison of Single-Window and Two-Window Posterolateral Approaches in Posterior and Lateral Malleolus Fractures: A Clinical Outcomes Analysis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Ankle fractures involving the posterior malleolus are complex injuries that require anatomical reduction and stable fixation to prevent post-traumatic osteoarthritis. The posterolateral surgical approach allows direct visualization and fixation of both the posterior and lateral malleoli through a single incision. However, the optimal deep dissection technique and fibular plating strategy remain controversial.

The traditional two-window technique involves creating one interval medial to the peroneal tendons for posterior malleolus fixation, and a second interval lateral to the peroneal tendons to apply a standard lateral anatomic plate to the fibula. Alternatively, the single-window technique utilizes only the interval medial to the peroneal tendons to fix both malleoli, utilizing a posterior antiglide plate for the fibula.

This prospective study aims to compare the clinical and functional outcomes of these two techniques. The primary hypothesis is that the single-window approach with posterior antiglide plating will significantly minimize soft-tissue stripping, thereby reducing the incidence of early wound complications and late implant-related irritation, while providing excellent biomechanical stability against external rotation forces.

Patients with acute, closed ankle fractures involving both the distal fibula and the posterior malleolus will be included. To avoid confounding variables and methodological bias, patients demonstrating persistent syndesmotic instability that requires additional trans-syndesmotic fixation (screws or buttons) will be excluded from the study, as the single-window approach inherently restricts direct lateral access for such procedures. Clinical evaluations will include the assessment of early wound complications (dehiscence, necrosis, infection) within the first 3 months, as well as functional outcomes using the American Orthopaedic Foot and Ankle Society (AOFAS) score, range of motion, and Visual Analog Scale (VAS) for pain at 6 and 12 months postoperatively.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Ankara Bilkent City Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Muhammed Kilic, MD
        • Sub-Investigator:
          • Fatih İnci, Assoc Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-Window Approach (Posterior Antiglide Plate)
Patients in this arm will undergo surgical fixation of the ankle fracture using a single-window posterolateral approach. Both the posterior malleolus and the lateral malleolus (fibula) will be accessed and reduced through a single surgical interval medial to the peroneal tendons (between the peroneal tendons and the flexor hallucis longus muscle). The fibula will be fixed using a posterior antiglide plate. No additional lateral surgical window will be created.
Procedure: Posterior Antiglide Plating
Fixation of the fibular fracture utilizing a posterior antiglide plate configuration applied directly to the posterior surface of the fibula.
Active Comparator: Two-Window Approach (Lateral Anatomic Plate)
Patients in this arm will undergo surgical fixation of the unstable ankle fracture using a two-window posterolateral approach. The posterior malleolus will be accessed and fixed through the first interval medial to the peroneal tendons. A second surgical interval (lateral window) will be intentionally developed lateral to the peroneal tendons to access and fix the fibula using a standard lateral anatomic plate.
Procedure: Lateral Anatomic Plating
Fixation of the fibular fracture utilizing a standard lateral anatomic plate configuration applied to the lateral surface of the fibula.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Wound Complications
Time Frame: Up to 3 months postoperatively
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.
Up to 3 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ankle Range of Motion (ROM)
Time Frame: 12 months postoperatively
Objective measurement of the ankle joint's maximal plantarflexion and dorsiflexion angles in degrees, assessed using a standard clinical goniometer.
12 months postoperatively
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score
Time Frame: 6 and 12 months postoperatively
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.
6 and 12 months postoperatively
Visual Analog Scale (VAS) for Pain
Time Frame: 6 and 12 months postoperatively
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.
6 and 12 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

muhammed kılıç

Investigators

  • Principal Investigator: Muhammed Kilic, MD, Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 15, 2026

First Submitted That Met QC Criteria

March 15, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TABED 1-24-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to institutional patient privacy regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ankle Fractures

Clinical Trials on Posterior Antiglide Plating

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe