Is Anterior Reversed Proximal Humeral Locking Plate System (PHILOS) a Safe Alternative to Conventional Posterior Double Plating in Extra-Articular Distal Shaft Humeral Fractures: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 68
- 试验地点
- 1
研究概览
简要总结
Extra-articular distal-third humeral shaft fractures are difficult to treat because stable fixation must be achieved while minimizing soft-tissue injury and the risk of nerve damage. Posterior double plating is a commonly used technique but requires extensive surgical exposure and routine handling of the radial and ulnar nerves. Anterior reversed proximal humeral locking plate system (PHILOS) fixation has emerged as a potential alternative that may provide adequate stability with less soft-tissue disruption.
This randomized controlled trial compares anterior reversed PHILOS plating with conventional posterior double plating in adult patients with extra-articular distal-third humeral shaft fractures. The study evaluates functional outcome using the Mayo Elbow Performance Score (MEPS) as primary outcome. Sexondary outcomes include: fracture union, operative parameters, range of motion, and complications including nerve injury, infection, and postoperative stiffness.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessment was performed by independent orthopedic surgeons who were blinded to treatment allocation. Radiological and functional outcomes were evaluated without knowledge of the intervention group.
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
- •Adults aged 18 years or older.
- •Acute extra-articular distal humeral shaft fracture.
- •AO/OTA type 12-A (simple) or 12-B (wedge) fracture.
- •Closed fracture.
- •Isolated injury.
- •Presentation within 14 days of injury.
- •Ability to provide informed consent and comply with follow-up.
排除标准
- •Open fractures.
- •Pathological fractures.
- •Previous surgery on the ipsilateral humerus.
- •Polytrauma requiring staged fixation.
- •Contraindication to general anesthesia.
- •Inability to complete the required follow-up period.
研究者
Mostafa Ahmed Shawky Mohamed
Lecturer
Cairo University
