Distal Femoral Fractures, Double Plating, Fixation, Single Lateral Plate
Conditions
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.
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.
Interventions
PROCEDURESingle 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.
PROCEDUREDouble 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.
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Score (KSS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Fracture Alignment | 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. |
| Radiological Union | 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. |
| Active Range of Motion | 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. |
| Degree of pain | 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. |
| Assessment of quality of Life | 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. |
Countries
Egypt
Outcome results
None listed