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.

Study Overview

• Status: Not yet recruiting
• Conditions: Proximal Interphalangeal Joint Fracture
• Intervention / Treatment: Device: Suzuki Frame; Procedure: Standard Conventional Treatment.

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 2
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yahia Mohamed Esmail, MSc; Phone Number: +20 12 20709009; Email: yehia_mohamed_post@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University Hospitals
    • Contact: Yahia Mohamed Esmail; Phone Number: +20 12 20709009; Email: yehia_mohamed_post@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: 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.
Active Comparator: 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).	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Outcome using the QuickDASH score.	The QuickDASH score is a standardized tool used to measure upper limb functional ability. Higher scores indicate greater disability (range 0-100).	6 months post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment using the Visual Analogue Scale (VAS)	Pain level assessed on a scale from 0 (no pain) to 10 (worst possible pain).	6 months post-operatively
Range of Motion (ROM) of the PIP joint.	Range of motion (ROM) expressed as the flexion-extension arc in degrees.	6 months post-operatively

Collaborators and Investigators

• Sponsor: Yehia Mohamed

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: July 15, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Comminuted Fracture; Suzuki Frame; Ligamentotaxis; Dynamic Joint Distraction; Finger Fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Comminuted
• Other Study ID Numbers: Soh-Med-26-3-15MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No