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

NCT07381725 | Completed

• 1 other identifier: FMBSUREC/02102022/Ali
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Single Lateral Plate; Double Plating; Distal Femoral Fractures; Fixation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Radiological Union

  52 weeks post-surgery

• Active Range of Motion

  52 weeks post-surgery

• Degree of pain

  52 weeks post-surgery

• Fracture Alignment

  52 weeks post-surgery

• Assessment of quality of Life

  12 months post-surgery

Study Arms (2)

Group I (Single Plate):

EXPERIMENTAL

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

Group II (Double Plate)

EXPERIMENTAL

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

Interventions

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.

Group I (Single Plate):

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.

Group II (Double Plate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni Suef University

Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

Location

MeSH Terms

Conditions

Femoral Fractures, Distal

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Orthopedic Surgery, Faculty of Medicine, Beni-Suef University, Egypt.

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 2, 2026
• Study Start: October 2, 2024
• Primary Completion: October 2, 2025
• Study Completion: October 2, 2025
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)