Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07481266

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

Led by muhammed kılıç · Updated on 2026-03-20

100

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the outcomes of two different surgical techniques for treating ankle fractures involving the posterior and lateral malleoli. This prospective clinical trial aims to determine if the single-window posterolateral approach reduces soft-tissue complications by minimizing surgical dissection, without affecting fracture stability. Patients with acute, closed ankle fractures requiring surgical fixation will be studied and followed for 12 months to assess wound healing, ankle function, pain, and implant irritation. Participants will be randomly assigned to one of two groups: one group will receive surgery using a single-window approach with a posterior antiglide plate to fix both malleoli through one surgical interval medial to the peroneal tendons. The other group will undergo the traditional two-window approach, involving two surgical intervals—one medial and one lateral to the peroneal tendons—with fixation of the fibula using a standard lateral anatomic plate. Both techniques aim to stabilize the fracture but differ in surgical exposure and plating methods. Throughout the study, patients will be closely monitored for early wound complications within the first three months after surgery. Further evaluations at 6 and 12 months will include functional assessments using the American Orthopaedic Foot and Ankle Society (AOFAS) score, ankle range of motion measurements, and pain levels using the Visual Analog Scale (VAS). The total participation duration is 12 months postoperatively, during which recovery and implant-related issues will be recorded to compare the effectiveness and safety of both surgical techniques.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged between 18 and 65 years
  • Diagnosis of an acute, closed, unstable rotational ankle fracture involving both posterior and lateral malleoli
  • Fracture type suitable for surgical reduction and internal fixation via a posterolateral approach
  • Ability to provide informed consent and comply with 12-month follow-up and rehabilitation
Not Eligible

You will not qualify if you...

  • Open fractures or severe tibial pilon variants
  • Fractures with intra-articular comminution beyond the posterior malleolus
  • Persistent syndesmotic instability requiring additional trans-syndesmotic fixation
  • Surgery delayed more than 7 days after injury
  • Severe conditions impairing healing such as peripheral arterial disease or uncontrolled diabetes with neuropathy
  • Previous fractures or surgeries on the same ankle

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 7 days from injury to surgery plus immediate recovery period

Participants undergo surgical fixation of their ankle fracture using either a single-window or two-window posterolateral approach to stabilize the posterior and lateral malleoli.

1 surgical visit and immediate post-operative assessments

Post-operative Follow-up

Duration - Up to 12 months postoperatively

Participants are monitored for wound healing and early complications, and their functional recovery is assessed using standardized ankle function and pain scores.

Approximately 6 follow-up visits over 12 months

Trial Site Locations

Total: 1 location

1

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye), 06800

Actively Recruiting

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Research Team

M

Muhammed Kilic, MD

F

Fatih İnci, Assoc Prof

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Posterior Antiglide Plating vs Lateral Neutralization Plating for Weber B Distal Fibular Fractures: A Systematic Review and Meta-analysis of Clinical and Biomechanical Studies.

Yi Deng, Thomas Lindsay Staniforth, Mohammad Saqib Zafar...

https://pubmed.ncbi.nlm.nih.gov/35373597

Modified Posterolateral Approach for the Treatment of 2-Part Fractures of the Posterior Malleolus Associated with Medial and Lateral Malleolar Fractures: 1 Incision, 2 Windows, 3 Steel Plates.

Yanqing Gu, Lei Zhao, Yan Ren...

https://pubmed.ncbi.nlm.nih.gov/35633024