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Completed

NCT Number: NCT07381725

Single Lateral Plate Versus Double Plating for the Fixation of Distal Femoral Fractures

This trial aimed to provide Level I evidence on the comparative effectiveness, safety, and functional outcomes of single versus double plating for distal femoral fractures.

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Key information

Conditions

Single Lateral Plate Distal Femoral Fractures Double Plating Femoral Fractures Femoral Fractures, Distal Fixation Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beni Suef University

Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

About this study

Distal femoral fractures, particularly those with metaphyseal comminution, present a significant surgical challenge with high risks of nonunion, malalignment, and functional impairment.

The single lateral locking plate (SLP) is a common fixation method but may lack sufficient stability in complex fractures, leading to varus collapse.

Dual plating (lateral and medial plates) offers enhanced biomechanical stability but involves greater surgical invasiveness.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years.
  • Acute, displaced, closed or Gustilo-Anderson Type I open distal femoral fracture (AO/OTA types 33-A1, A2, A3, C1, C2, C3).
  • Presentation within 7 days of injury.
  • Provision of written informed consent.

Exclusion criteria

  • Pathological fractures.
  • Associated ipsilateral lower extremity trauma (floating knee).
  • Associated neurovascular injury requiring repair.
  • Pre-existing symptomatic knee arthritis or prior major knee surgery.
  • Active local or systemic infection.
  • Medical comorbidities precluding surgery or anesthesia [American Society of Anesthesiologists (ASA) class IV/V].
  • Cognitive impairment or inability to comply with follow-up.

Treatment and study plan

Single lateral distal femoral locking compression plate

Procedure

Patients underwent open Reduction and Internal Fixation (ORIF) using a single pre-contoured lateral distal femoral locking compression plate via a standard lateral approach.

double plating

Procedure

Patients underwent open Reduction and Internal Fixation (ORIF) using a lateral distal femoral locking plate combined with a medial buttress plate (3.5mm reconstruction plate) via an anterolateral approach with subvastus medial dissection.

Primary outcomes

  1. Knee Society Score (KSS)

    Time frame: 6 months post-surgery

    The Knee Society Score (KSS) contains questions in 2 sections: knee joint (pain, range of motion, stability) and function (walking distance, ability to climb stairs). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.

Secondary outcomes

  1. Radiological Union

    Time frame: 52 weeks post-surgery

    Radiological Union (defined as bridging callus in 3/4 cortices) was recorded. It was assessed at 2, 6, 12, 24, and 52 weeks post-surgery.

  2. Active Range of Motion

    Time frame: 52 weeks post-surgery

    Active Range of Motion was measured with a goniometer assesses the joint angle achieved through a patient's voluntary muscle contraction, without external assistance. It was assessed at 2, 6, 12, 24, and 52 weeks post-surgery.

  3. Degree of pain

    Time frame: 52 weeks post-surgery

    Degree of pain was assessed using Visual Analogue Scale (VAS). The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). It was assessed at 2, 6, 12, 24, and 52 weeks post-surgery.

  4. Fracture Alignment

    Time frame: 52 weeks post-surgery

    Fracture Alignment on Anterior Posterior (AP)/Lateral radiographs was recorded. It was assessed at 2, 6, 12, 24, and 52 weeks post-surgery.

  5. Assessment of quality of Life

    Time frame: 12 months post-surgery

    Quality of Life was assessed using EQ-5D-5L questionnaire across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It was assessed at 6 and 12 months post-surgery.

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

A Comparative Analysis of Single Lateral Plate Versus Double Plating for the Fixation of Distal Femoral Fractures: A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

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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