Early Weight Bearing in Distal Femur Fractures
ConditionDistal Femur Fracture
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University
About this trial
Assessment of the effect of double plating and single lateral plating on early weight bearing as a primary outcome and improving union and decreasing complications as secondary outcomes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Skeletally mature patients.
Distal femur fracture type A2, A3, C1, C2 by X-ray (Arbeitsgemeinschaft für Osteosynthesefragen classification).
Injury Severity Score below 15.
Controlled comorbidities.
Disqualifiers
Distal femur fractures type A1, B, C3 and A2 if there is a medial wedge.
Open fracture grade 3 Gustilo Anderson Classification.
Trial design
Design model
Parallel
Treatments tested in this trial
dual plating
Procedure/Surgerysurgical fixation of the distal femur using two plates to enhance stability and fracture healing.
single plating
Procedure/Surgerysurgical fixation of the distal femur using a single plate according to standard fixation protocols.
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: Dual platingExperimental treatment 1 intervention
Group B: single platingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sander's scale.
A scale of 40 points with 0 as the minimum value and 40 as the maximum value. A higher score means a better outcome. The scale is used as a functional outcome following distal femur fractures fixation using questionaire about the pain, walking ability and return of work and using x rays to measure angulation in degrees and shortening in centimeters and examining the range of motion of the knee joint in degrees.
Time frame
one yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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