Functional Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorAssiut University
About this trial
The aim of our study is to identify if there is statistically significant difference in patient reported functional outcomes in cases of unstable ankle fracture managed by ORIF with and without ankle arthroscopy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
rotational ankle fracture Danis-Weber classification B or C fibula fracture
fracture dislocation ankle
Fractures extending into the tibial plafond,
Talus fractures (body or neck) in our institution
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
ankle arthroscopy with ORIF
Procedure/Surgerywe will go for fixation of the fracture with association of scope intervention pre and post fixation
fracture ankle fixation without ankle arthroscopy
Procedure/Surgerywe will go for fixation of the fracture alone with no scope intervention
Treatment groups
176 Participants
are divided into 2 treatment groupsGroup A: those patients who will go for ORIF plus arthroscopyExperimental treatment 1 intervention
Group B: patients who will go for ORIF without arthroscopyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
American Orthopaedic Foot and Ankle Society(AOFAS) hindfoot score
AOFAS hindfoot score difference between the 2 groups at 6 months and one year postoperatively from 0 to 100 where higher value indicates better functional outcomes
Time frame
6 months and one year follow upLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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