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

Not Applicable

Completed

• Conditions: Posterior Malleolus Fractures; Ankle Fractures
• Interventions: Procedure: Internal fixation

• Registration Number: NCT05084794
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2015-10-01
• Primary Completion: 2019-10-31
• Study First Submitted: 2021-10-08
• Study First Submitted QC: 2021-10-18
• Study First Posted: 2021-10-20
• Study Completion: 2021-10-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixated	Internal fixation	Posterior malleolus fractures will be fixated with either plate or screws.

Primary Outcome Measures

Name	Time	Method
Short Musculoskeletal Function Assessment (SMFA) Questionnaire	2 year	Functional outcome score between 0 and 100. Higher score indicates a worse function.
American Orhopaedic Foot and Ankle Score (AOFAS) Score	5 year	Functional outcome score between 0 and 100. Higher score indicates better function.
Kellgren-Lawrence grading system for osteoarthritis	2 year	Grade of ankle osteroarthritis. Score between 0 to 4. Higher score indicates worse joint cartilage.