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

Ankle Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05084794
• Other study ID #: A-22/01.09.2015
• Status: Completed
• Phase: N/A
• Start date: October 1, 2015
• Est. completion date: October 31, 2021

Study information

• Verified date: May 2022
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone
• Posterior Malleolus Fractures

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

Outcome

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