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

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

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.

Study Overview

• Status: Completed
• Conditions: Distal Femoral Fractures; Fixation; Single Lateral Plate; Double Plating
• Intervention / Treatment: Procedure: Single lateral distal femoral locking compression plate; Procedure: Double Plating

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Beni Suweif Governorate
    • Banī Suwayf, Beni Suweif Governorate, Egypt, 62511
      • Beni suef university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (Single Plate): Patients underwent open Reduction and Internal Fixation (ORIF) using a single pre-contoured lateral distal femoral locking compression plate via a standard lateral approach.	Procedure: Single lateral distal femoral locking compression plate; Patients underwent open Reduction and Internal Fixation (ORIF) using a single pre-contoured lateral distal femoral locking compression plate via a standard lateral approach.
Experimental: Group II (Double Plate); 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.	Procedure: Double Plating; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Society Score (KSS)	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.	6 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological Union	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.	52 weeks post-surgery
Active Range of Motion	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.	52 weeks post-surgery
Degree of pain	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.	52 weeks post-surgery
Fracture Alignment	Fracture Alignment on Anterior Posterior (AP)/Lateral radiographs was recorded. It was assessed at 2, 6, 12, 24, and 52 weeks post-surgery.	52 weeks post-surgery
Assessment of quality of Life	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.	12 months post-surgery

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2024
• Primary Completion (Actual): October 2, 2025
• Study Completion (Actual): October 2, 2025

Study Registration Dates

• First Submitted: January 25, 2026
• First Submitted That Met QC Criteria: January 25, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 25, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures; Femoral Fractures, Distal
• Other Study ID Numbers: FMBSUREC/02102022/Ali

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No