Management of Diaphyseal Forearm Fractures in Adolescents
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 →
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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