跳至主要内容
临床试验/NCT07645768
NCT07645768进行中(未招募)不适用

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

Cairo University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2025年12月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mostafa Ahmed Shawky Mohamed

Lecturer

Cairo University

研究点 (1)

Loading locations...

相似试验