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Not yet recruiting NCT07705347

Management of Diaphyseal Forearm Fractures in Adolescents

No phase Interventional Forearm Fractures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Open reduction and internal fixation, Closed or mini-open reduction and fixation.
Who it may be relevant to
Registry conditions: Forearm Fractures. Basic parameters: 10 years — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

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

Primary outcome measures

  • Functional outcome assessed using the Grace and Eversmann scoring system. [Time frame: 6 months]
Secondary outcome measures (1)
  • Radiographic Bone Union Time [Time frame: 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of medicine, Sohag university — Sohag

Identifiers

NCT: NCT07705347 · Soh-Med-26-6-18MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗