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

Beni-Suef University38 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Single Lateral Plate Double Plating Fixation Distal Femoral Fractures

Interventions

Single lateral distal femoral locking compression platePROCEDURE

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 PlatingPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beni Suef University

Banī Suwayf, Beni Suweif Governorate, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 6 months post-surgery

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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