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OpenTrials
Completed

NCT Number: NCT05084794

The Results of Middle-sized Posterior Malleolus Fractures: Fixed Versus Non-fixed

This study aims prospective randomized comparison of mid-term clinical outcomes of middle-sized posterior malleolus fractures with and without internal fixation.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Although it has traditionally been accepted that posterior malleolar fractures involving less than 25 percent of the tibial plafond do not require operative fixation, this belief is now questioned. A number of studies have shown that the posterior malleolus contributes significantly to ankle stability. Many studies have also demonstrated that postoperative outcomes are better in patients who underwent posterior malleolar reduction and fixation.

The aim of this prospective study is to show how internal fixation of the posterior malleolus, including middle-sized posterior malleolar fractures (10-25%), affects clinical outcomes and to discuss the factors that may lead to arthritis of the ankle joint. The groups will be randomized. The clinical and functional results of 40 patients who will be operated between 2015-2019 due to ankle fracture will be evaluated at short to mid-term (2-5 years). According to our hypothesis, internally fixed posterior malleolar fractures give better clinical and functional scores.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who were operated for ankle fractures, including posterior malleolar fracture between 10-25% of the joint surface. Two to five years of follow-up with functional and radiological outcome.

Exclusion criteria

Posterior malleolar fractures accompanied by severe soft tissue damage after high-energy injury will not be included in the study. Written consent will be obtained from all participants, patients who do not give consent or refuse to participate will not be included in the study. Patients who left the study voluntarily will not be included in the statistics. Patients with additional joint disorders, previous surgery or previous history of ankle complaint will not be included.

Treatment and study plan

Internal fixation

Procedure

Fixation of posterior malleolus with either plate or screws.

Primary outcomes

  1. Short Musculoskeletal Function Assessment (SMFA) Questionnaire

    Time frame: 2 year

    Functional outcome score between 0 and 100. Higher score indicates a worse function.

  2. Kellgren-Lawrence grading system for osteoarthritis

    Time frame: 2 year

    Grade of ankle osteroarthritis. Score between 0 to 4. Higher score indicates worse joint cartilage.

  3. American Orhopaedic Foot and Ankle Score (AOFAS) Score

    Time frame: 5 year

    Functional outcome score between 0 and 100. Higher score indicates better function.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

Does Fixation of Medium-sized Posterior Malleolus Fractures Provide Better Outcome?

Important dates

Study start
2015
Primary completion
2019
Study completion
2021
First posted
Oct 20, 2021
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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