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临床试验/NCT07714356
NCT07714356尚未招募不适用

Evaluation of Suzuki Frame Fixation in Comminuted Fractures of the Proximal Interphalangeal Joint.

Yehia Mohamed1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
2
试验地点
1
主要终点
Functional Outcome using the QuickDASH score.

研究概览

简要总结

This prospective randomized controlled trial aims to evaluate the functional and radiological outcomes of using the Suzuki frame for treating comminuted intra-articular fractures of the proximal interphalangeal (PIP) joint. The study involves adult patients with PIP joint fractures who will be treated using dynamic joint distraction (ligamentotaxis) via the Suzuki frame. The primary goal is to assess whether this technique facilitates early active finger motion, reduces joint stiffness, and improves long-term functional recovery compared to other methods.

详细描述

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

入选标准

  • Age ≥18 years.
  • Either sex.
  • Simple or compound (open) fractures.
  • Isolated fracture involving a single finger.
  • Comminuted intra-articular proximal interphalangeal (PIP) joint fractures.

排除标准

  • Age <18 years.
  • Fractures involving the thumb.
  • Fractures involving the toes.
  • Near-total finger amputations.

结局指标

主要结局

Functional Outcome using the QuickDASH score.

时间窗: 6 months post-operatively

The QuickDASH score is a standardized tool used to measure upper limb functional ability. Higher scores indicate greater disability (range 0-100).

次要结局

  • Pain assessment using the Visual Analogue Scale (VAS)(6 months post-operatively)
  • Range of Motion (ROM) of the PIP joint.(6 months post-operatively)

研究者

发起方
Yehia Mohamed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yehia Mohamed

Resident at the Department of Orthopedics Surgery and Traumatology

Sohag University

研究点 (1)

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