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

Beni-Suef University

Status: Completed

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

Treatments: Procedure: Single lateral distal femoral locking compression plate; Procedure: Double Plating

Study type: Interventional

Funder types: Other

Identifiers

NCT07381725

FMBSUREC/02102022/Ali

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Group I (Single Plate):

Experimental group

Description:

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

Treatment:

Procedure: Single lateral distal femoral locking compression plate

Group II (Double Plate)

Experimental group

Description:

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.

Treatment:

Procedure: Double Plating