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Management of Diaphyseal Forearm Fractures in Adolescents

NCT07705347 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-07-15
Last updated
2026-07-15

Condition(s) studied

Forearm Fractures

Investigational drug(s) / intervention(s)

Open reduction and internal fixationClosed or mini-open reduction and fixation

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.

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

Study summary

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

Eligibility

Sex
ALL
Min age
10 Years
Max age
16 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Functional outcome assessed using the Grace and Eversmann scoring system. — 6 months

Trial sites (1)

FacilityCityRegionStatus
Faculty of medicine, Sohag university Sohag Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07705347 on ClinicalTrials.gov ↗ ← All trials in Egypt