Early Weight Bearing in Distal Femur Fractures

January 28, 2025 updated by: Mohamed Tarek Mahmoud Ahmed, Assiut University

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dual plating
Participants in this group will undergo dual plating fixation for distal femur fractures.
Procedure: dual plating
surgical fixation of the distal femur using two plates to enhance stability and fracture healing.
Active Comparator: single plating
Participants in this group will undergo single plate fixation for distal femur fractures.
Procedure: single plating
surgical fixation of the distal femur using a single plate according to standard fixation protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

January 18, 2025

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Early weight-bearing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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