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NCT Number: NCT07714356

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

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.

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Key information

Conditions

Proximal Interphalangeal Joint Fracture Fractures, Bone Fractures, Comminuted Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Suzuki Frame

Device

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.

Standard Conventional Treatment.

Procedure

"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.

Primary outcomes

  1. Functional Outcome using the QuickDASH score.

    Time frame: 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).

Secondary outcomes

  1. Pain assessment using the Visual Analogue Scale (VAS)

    Time frame: 6 months post-operatively

    Pain level assessed on a scale from 0 (no pain) to 10 (worst possible pain).

  2. Range of Motion (ROM) of the PIP joint.

    Time frame: 6 months post-operatively

    Range of motion (ROM) expressed as the flexion-extension arc in degrees.

Study contacts

Contact information is provided by the study sponsor or research team.

Yahia Mohamed Esmail, MSc

CONTACT

[email protected]

+20 12 20709009

Sponsors and collaborators

Lead sponsor

Yehia Mohamed

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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