Management of Diaphyseal Forearm Fractures in Adolescents

July 10, 2026 updated by: Ramadan Moanes Ramadan, Sohag University

Locking Compression Mini-plate Osteosynthesis Versus Titanium Elastic Intramedullary Nailing in Management of Diaphyseal Forearm Fractures in Adolescents

evaluate and compare the clinical, and radiographic outcomes of 2.7 mm locking compression mini-plate osteosynthesis versus titanium elastic intramedullary nail (TEN) in the surgical management of diaphyseal fractures of both forearm bones in adolescent patients

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

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
        • Faculty of medicine, Sohag university
        • Contact:

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age: 10 to 16 years (at time of injury).

  2. Fracture pattern: diaphyseal fracture involving both the radius or ulna.

    o Fracture location: Diaphysis defined as the segment between the proximal metaphyseal flare (distal to bicipital tuberosity for radius; distal to coronoid process for ulna) and the distal metaphyseal flare (within 3 cm of the distal physis).

  3. Indication for surgery: Failure of closed reduction or unacceptable alignment after attempted closed reduction, defined as:

    • Angulation > 15° in any plane (sagittal or frontal).
    • Translation > 50% of bone diameter.
    • Bayonet apposition.
    • Open fracture (Gustilo type I).
    • Inability to maintain acceptable reduction after cast immobilization (loss of reduction).
  4. Skeletal maturity: Open or partially open distal radial physis (assessed on preoperative radiographs).

Exclusion Criteria:

  1. Open fracture Gustilo type II & III.
  2. Pathological fracture (secondary to bone cyst, tumor, osteogenesis imperfecta, etc.).
  3. Neurovascular compromise requiring emergent exploration (e.g., acute compartment syndrome, pulseless limb after reduction).
  4. Floating elbow (ipsilateral supracondylar humerus fracture + forearm fracture).
  5. Monteggia or Galeazzi fracture-dislocation patterns
  6. Metabolic bone disease (e.g., rickets, osteomalacia, renal osteodystrophy).
  7. Neuromuscular disorder affecting upper extremity function (e.g., cerebral palsy, muscular dystrophy, brachial plexus injury).
  8. Active infection at surgical site or systemic infection.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group (plate)
Group A (mini-Plate group): Open reduction and internal fixation (ORIF) using a 2.7 mm locking compression mini-plate (LCP) system
Procedure: Open reduction and internal fixation
Group A (mini-Plate group): Open reduction and internal fixation (ORIF) using a 2.7 mm locking compression mini-plate (LCP) system.
Active Comparator: Group (TENs)
Group B (TEN group): Closed or mini-open reduction and fixation using titanium elastic nails (TENs)
Procedure: Closed or mini-open reduction and fixation
Group B (TEN group): Closed or mini-open reduction and fixation using titanium elastic nails (TENs).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional outcome assessed using the Grace and Eversmann scoring system.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Bone Union Time
Time Frame: 6 months
the time until bridging callus is visible across at least 3 of 4 cortices on standard AP and lateral X-rays
6 months

Collaborators and Investigators

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

Sponsor

Sohag University

Investigators

  • Principal Investigator: ramadan moanes, Faculty of medicine, 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 (Estimated)

July 15, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

June 29, 2026

First Submitted That Met QC Criteria

July 10, 2026

First Posted (Actual)

July 15, 2026

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 10, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-26-6-18MS

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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