The Results of Middle-sized Posterior Malleolus Fractures: Fixed Versus Non-fixed
Does Fixation of Medium-sized Posterior Malleolus Fractures Provide Better Outcome?
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
This study aims prospective randomized comparison of mid-term clinical outcomes of middle-sized posterior malleolus fractures with and without internal fixation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2015
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2019
CompletedFirst Submitted
Initial submission to the registry
October 8, 2021
CompletedFirst Posted
Study publicly available on registry
October 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2021
CompletedMay 26, 2022
May 1, 2022
4.1 years
October 8, 2021
May 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Short Musculoskeletal Function Assessment (SMFA) Questionnaire
Functional outcome score between 0 and 100. Higher score indicates a worse function.
2 year
Kellgren-Lawrence grading system for osteoarthritis
Grade of ankle osteroarthritis. Score between 0 to 4. Higher score indicates worse joint cartilage.
2 year
American Orhopaedic Foot and Ankle Score (AOFAS) Score
Functional outcome score between 0 and 100. Higher score indicates better function.
5 year
Study Arms (2)
Non-fixated
NO INTERVENTIONPosterior malleolus fractures won't be fixated.
Fixated
EXPERIMENTALPosterior malleolus fractures will be fixated with either plate or screws.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 8, 2021
First Posted
October 20, 2021
Study Start
October 1, 2015
Primary Completion
October 31, 2019
Study Completion
October 31, 2021
Last Updated
May 26, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share