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Clinical Trials/NCT06806839
NCT06806839Not yet recruitingNot Applicable

Early Weight Bearing in Distal Femoral Fractures, Dual Plating Versus Single Lateral Plating: a Randomized Controlled Study

Assiut University0 sites34 target enrollmentStarted: February 1, 2025Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
34
Primary Endpoint
Sander's scale.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Skeletally mature patients.
  • •Distal femur fracture type A2, A3, C1, C2 by X-ray (Arbeitsgemeinschaft für Osteosynthesefragen classification).
  • •Injury Severity Score below
  • •Controlled comorbidities.
  • •Fresh fractures: within 3 weeks of trauma.

Exclusion Criteria

  • •Distal femur fractures type A1, B, C3 and A2 if there is a medial wedge.
  • •Open fracture grade 3 Gustilo Anderson Classification.

Outcomes

Primary Outcomes

Sander's scale.

Time Frame: one year

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Tarek Mahmoud Ahmed

Resident

Assiut University

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