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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Suzuki Frame
  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.
• Процедура Standard Conventional Treatment.
  "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.

Первичные конечные точки

• Functional Outcome using the QuickDASH score. [Срок оценки: 6 months post-operatively]

Вторичные конечные точки (2)

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

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Sohag University Hospitals — Sohag

Идентификаторы

NCT: NCT07714356 · Soh-Med-26-3-15MS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗