search
Back to results

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

Primary Purpose

Ankle Fractures, Posterior Malleolus Fractures

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Internal fixation
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fractures focused on measuring ankle, fracture, posterior, malleolus, fixation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Non-fixated

    Fixated

    Arm Description

    Posterior malleolus fractures won't be fixated.

    Posterior malleolus fractures will be fixated with either plate or screws.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    October 8, 2021
    Last Updated
    May 19, 2022
    Sponsor
    Istanbul University - Cerrahpasa (IUC)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05084794
    Brief Title
    The Results of Middle-sized Posterior Malleolus Fractures: Fixed Versus Non-fixed
    Official Title
    Does Fixation of Medium-sized Posterior Malleolus Fractures Provide Better Outcome?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2015 (Actual)
    Primary Completion Date
    October 31, 2019 (Actual)
    Study Completion Date
    October 31, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University - Cerrahpasa (IUC)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ankle Fractures, Posterior Malleolus Fractures
    Keywords
    ankle, fracture, posterior, malleolus, fixation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Non-fixated
    Arm Type
    No Intervention
    Arm Description
    Posterior malleolus fractures won't be fixated.
    Arm Title
    Fixated
    Arm Type
    Experimental
    Arm Description
    Posterior malleolus fractures will be fixated with either plate or screws.
    Intervention Type
    Procedure
    Intervention Name(s)
    Internal fixation
    Intervention Description
    Fixation of posterior malleolus with either plate or screws.
    Primary Outcome Measure Information:
    Title
    Short Musculoskeletal Function Assessment (SMFA) Questionnaire
    Description
    Functional outcome score between 0 and 100. Higher score indicates a worse function.
    Time Frame
    2 year
    Title
    Kellgren-Lawrence grading system for osteoarthritis
    Description
    Grade of ankle osteroarthritis. Score between 0 to 4. Higher score indicates worse joint cartilage.
    Time Frame
    2 year
    Title
    American Orhopaedic Foot and Ankle Score (AOFAS) Score
    Description
    Functional outcome score between 0 and 100. Higher score indicates better function.
    Time Frame
    5 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs