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NCT07705347
Management of Diaphyseal Forearm Fractures in Adolescents
Conditions: Forearm Fractures
Sex: All
Ages: 10 Years – 16 Years
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Sohag University
Location: Faculty of medicine, Sohag university Sohag
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07705347). StuddyBuddy aggregates publicly available trial information.