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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05084794
Enrollment
40
Registered
2021-10-20
Start date
2015-10-01
Completion date
2021-10-31
Last updated
2022-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Fractures, Posterior Malleolus Fractures

Keywords

ankle, fracture, posterior, malleolus, fixation

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.

Interventions

Fixation of posterior malleolus with either plate or screws.

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Short Musculoskeletal Function Assessment (SMFA) Questionnaire2 yearFunctional outcome score between 0 and 100. Higher score indicates a worse function.
Kellgren-Lawrence grading system for osteoarthritis2 yearGrade of ankle osteroarthritis. Score between 0 to 4. Higher score indicates worse joint cartilage.
American Orhopaedic Foot and Ankle Score (AOFAS) Score5 yearFunctional outcome score between 0 and 100. Higher score indicates better function.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026