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NCT Number: NCT06806839

Early Weight Bearing in Distal Femur Fractures

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.

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Key information

Conditions

Distal Femur Fracture Femoral Fractures Femoral Fractures, Distal Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dual plating

Procedure

surgical fixation of the distal femur using two plates to enhance stability and fracture healing.

single plating

Procedure

surgical fixation of the distal femur using a single plate according to standard fixation protocols.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

mohamed TM Ahmed, MBBCh

CONTACT

[email protected]

+0201065442587

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 4, 2025
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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