Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07481266

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

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

100

Participants Needed

1

Research Sites

158 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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
  • Acute, closed, unstable rotational ankle fracture involving both posterior malleolus and lateral malleolus
  • Fracture type requiring surgical reduction and fixation via a posterolateral approach (e.g., Bartonicek Type II, III, or IV)
  • Ability to give informed consent and comply with 12-month follow-up and rehabilitation
Not Eligible

You will not qualify if you...

  • Open fractures, severe tibial pilon injuries, or fractures with intra-articular comminution beyond the posterior malleolus
  • Persistent syndesmotic instability requiring additional fixation after posterior and lateral malleoli repair
  • Surgery delayed more than 7 days after injury causing organized hematoma or poor soft-tissue condition
  • Severe peripheral arterial disease, uncontrolled diabetes with neuropathy, or severe ipsilateral ankle osteoarthritis
  • Previous fractures or surgeries on the same ankle

AI-Screening

AI-Powered Screening

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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

CONTACT

F

Fatih İnci, Assoc Prof

CONTACT

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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