Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07705347

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

  • 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).
  • Skeletal maturity: Open or partially open distal radial physis (assessed on preoperative radiographs).

Exclusion criteria

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

Treatment and study plan

Open Reduction and Internal Fixation

Procedure

Group A (mini-Plate group): Open reduction and internal fixation (ORIF) using a 2.7 mm locking compression mini-plate (LCP) system.

Closed or mini-open reduction and fixation

Procedure

Group B (TEN group): Closed or mini-open reduction and fixation using titanium elastic nails (TENs).

Primary outcomes

  1. Functional outcome assessed using the Grace and Eversmann scoring system.

    Time frame: 6 months

Secondary outcomes

  1. 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

Study contacts

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

Ramadan Moanes

CONTACT

[email protected]

+201068323176

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 15, 2026
Registry last updated
Jul 15, 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.

Published trials that share one or more normalized conditions with this study.