Is Anterior Reversed Proximal Humeral Locking Plate System (PHILOS) a Safe Alternative to Conventional Posterior Double Plating in Extra-Articular Distal Shaft Humeral Fractures
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
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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Cairo、埃及
- Trauma and Orthopedic department, Faculty of Medicine, Cairo University
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Anterior Reversed PHILOS Plating
Patients with extra-articular distal-third humeral shaft fractures treated using an anterior approach and fixation with a reversed Proximal Humeral Internal Locking System (PHILOS) plate.
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Fixation of extra-articular distal-third humeral shaft fractures using a reversed proximal humeral internal locking system (PHILOS) plate applied to the anterior surface of the humerus through an anterior approach.
The construct was secured with locking screws proximal and distal to the fracture site.
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实验性的:Posterior Double Plating
Patients with extra-articular distal-third humeral shaft fractures treated using a posterior approach and fixation with orthogonal double plates applied medially and posterolaterally.
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Fixation of extra-articular distal-third humeral shaft fractures through a posterior approach using orthogonal double plates applied medially and posterolaterally after fracture reduction.
Both radial and ulnar nerves were identified and protected during the procedure.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mayo Elbow Performance Score (MEPS)
大体时间:24 months after surgery
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pain (45 points), range of motion (20 points), stability (10 points), and daily functional tasks (25 points).
Total maximum score is 100 meaning best outcome and total minimum score is 10 indicating worst outcome
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24 months after surgery
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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手术时间
大体时间:术中
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术中
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Fracture Union
大体时间:Upto 24 months after surgery
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Upto 24 months after surgery
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Nerve injury complications
大体时间:Immediately postoperative
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Immediately postoperative
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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