Evaluation of Suzuki Frame Fixation in Comminuted Fractures of the Proximal Interphalangeal Joint.
研究概览
地位
详细说明
Fractures involving the proximal interphalangeal (PIP) joint are challenging to manage, often leading to pain, stiffness, and functional impairment. Dynamic joint distraction using ligamentotaxis has emerged as an alternative to open surgery to facilitate early mobilization while avoiding the risks of soft-tissue dissection.
In this study, we are investigating the short-term functional and radiological outcomes of the Suzuki frame, which utilizes a 1.2-mm Kirschner wire axial traction pin and a hook pin connected by rubber bands to maintain joint congruency. Participants will include adults with isolated, comminuted intra-articular PIP joint fractures. Patients will be monitored over a 6-month follow-up period.
Clinical evaluation will include the Visual Analogue Scale (VAS) for pain and the QuickDASH score for functional disability. Radiological assessment will focus on joint alignment and reduction. The study will be conducted at Sohag University Hospital, following an intention-to-treat analysis principle.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Yahia Mohamed Esmail, MSc
- 电话号码:+20 12 20709009
- 邮箱:yehia_mohamed_post@med.sohag.edu.eg
学习地点
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Sohag、埃及
- Sohag University Hospitals
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接触:
- Yahia Mohamed Esmail
- 电话号码:+20 12 20709009
- 邮箱:yehia_mohamed_post@med.sohag.edu.eg
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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:
- Age ≥18 years.
- Either sex.
- Simple or compound (open) fractures.
- Isolated fracture involving a single finger.
- Comminuted intra-articular proximal interphalangeal (PIP) joint fractures.
Exclusion Criteria:
- Age <18 years.
- Fractures involving the thumb.
- Fractures involving the toes.
- Near-total finger amputations.
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:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Suzuki Frame Fixation Group
Patients with comminuted intra-articular proximal interphalangeal (PIP) joint fractures treated with dynamic joint distraction using the Suzuki frame (1.2-mm Kirschner wires and rubber bands).
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Dynamic joint distraction using a 1.2-mm axial traction K-wire in the proximal phalanx, a 1.2-mm hook K-wire in the middle phalanx, and rubber bands to maintain joint congruency and facilitate early motion.
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有源比较器:Standard Conventional Treatment Group
Patients with comminuted intra-articular proximal interphalangeal (PIP) joint fractures treated using standard conventional management as per hospital protocol (e.g., closed reduction and splinting or internal fixation).
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"tandard conventional management of comminuted intra-articular proximal interphalangeal joint fractures according to institutional protocols, including closed reduction and splinting or open reduction internal fixation as indicated.
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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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Functional Outcome using the QuickDASH score.
大体时间:6 months post-operatively
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The QuickDASH score is a standardized tool used to measure upper limb functional ability.
Higher scores indicate greater disability (range 0-100).
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6 months post-operatively
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain assessment using the Visual Analogue Scale (VAS)
大体时间:6 months post-operatively
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Pain level assessed on a scale from 0 (no pain) to 10 (worst possible pain).
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6 months post-operatively
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Range of Motion (ROM) of the PIP joint.
大体时间:6 months post-operatively
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Range of motion (ROM) expressed as the flexion-extension arc in degrees.
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6 months post-operatively
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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 (估计的)
初级完成 (估计的)
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
与本研究相关的术语
其他研究编号
- Soh-Med-26-3-15MS
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
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