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

NCT05084794 — Not applicable, Completed, 40 participants, Istanbul University - Cerrahpasa

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

Registry	NCT05084794
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	40 (Actual)
Sponsor	Istanbul University - Cerrahpasa (Other)
Conditions	Ankle Fractures, Posterior Malleolus Fractures
Interventions	Internal fixation (Procedure)
Dates	start 2015-10-01, primary completion 2019-10-31, completion 2021-10-31, first posted 2021-10-20, last updated 2022-05-26

-Summary

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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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Non-fixated	No intervention		Posterior malleolus fractures won't be fixated.
Fixated	Experimental	Procedure: Internal fixation	Posterior malleolus fractures will be fixated with either plate or screws.

Internal fixation (Procedure): Fixation of posterior malleolus with either plate or screws.

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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.