A Comparative Analysis of Single Lateral Plate Versus Double Plating for the Fixation of Distal Femoral Fractures: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Knee Society Score (KSS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Single lateral distal femoral locking compression plate (Procedure)
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.
干预措施: Double Plating (Procedure)
结局指标
主要结局
Knee Society Score (KSS)
时间窗: 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.
次要结局
- 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)
研究者
Mohamed Ahmed Abdelkader
Lecturer of Orthopedic Surgery, Faculty of Medicine, Beni-Suef University, Egypt.
Beni-Suef University