Evaluation of Dual Fixation of Distal Ulna Fractures by Flexible Intramedullary Nail and Mini Locked Plate 2.7 mm.

April 21, 2026 updated by: Mostafa Ali Hamed, Sohag University

Evaluation of Dual Fixation of Distal Ulna Fractures by Flexible Intramedullary Nail and Mini Locked Plate 2.7 mm

Although isolated fixation methods, such as intramedullary nails or plate fixation, are commonly employed, certain fracture patterns-particularly comminuted, osteoporotic, or unstable fractures- represent a challenge to achieve stable fixation and restoring normal anatomy .

Dual fixation, combining an intramedullary nail with a low-profile 2.7-mm mini locked plate, aims to capitalize on the strengths of both techniques-a concept known as "orthogonal or hybrid stabilization". This combined approach provides enhanced biomechanical stability, allows for early mobilization by sharing the mechanical load, and minimizes the risk of non-union or hardware failure. Studying the clinical and radiological outcomes of this dual fixation strategy is essential to establish its efficacy and safety in managing complex distal ulna fractures.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Faculty of medicine sohag university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Displaced distal ulna fractures either isolated or with associated distal radius fractures.
  • Unstable distal ulna fractures
  • Age group: [Adults aged 18 years and older].

Exclusion Criteria:

  • Open fractures with severe soft tissue injury (Gustilo type III).
  • Pathological fractures.
  • Patients with systemic conditions affecting bone healing e.g. uncontrolled diabetes and severe osteoporosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Distal ulna fractures
Procedure: Dual fixation of distal ulna fractures by flexible intramedullary nail and mini locked plate 2.7 mm
Evaluation of dual fixation of distal ulna fractures by flexible intramedullary nail and mini locked plate 2.7 mm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiological union
Time Frame: 24 Weeks

Number of patients achieving complete bone healing as assessed by serial X-rays (presence of bridging callus on 3 out of 4 cortices).

Unit of Measure: Number of Participants.
24 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Hand Grip Strength
Time Frame: 24 weeks

Measurement of the physical force of the hand using a calibrated Jamar hydraulic hand dynamometer. The average of three successive trials with the affected hand will be recorded.

Unit of Measure: Kilograms.
24 weeks
Range of Motion (ROM) of the affected joint (wrist)
Time Frame: 24 weeks

Clinical measurement of the degree of movement in the joint (flexion, extension, pronation, and supination) using a standard goniometer.

Unit of Measure: Degrees.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-26-2-1MS

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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