Management of Diaphyseal Forearm Fractures in Adolescents

NCT07705347 — Not applicable, Not yet recruiting, 20 participants, Sohag University

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

Registry	NCT07705347
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	20 (Estimated)
Sponsor	Sohag University (Other)
Conditions	Forearm Fractures
Interventions	Open reduction and internal fixation, Closed or mini-open reduction and fixation (Procedure)
Dates	start 2026-07-15 (estimated), primary completion 2027-01-01 (estimated), completion 2027-06-01 (estimated), first posted 2026-07-15, last updated 2026-07-15
Locations	1 site in Egypt

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Group (plate)	Active comparator	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
Group (TENs)	Active comparator	Procedure: Closed or mini-open reduction and fixation	Group B (TEN group): Closed or mini-open reduction and fixation using titanium elastic nails (TENs)

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).

+Outcome measures

Primary outcomes

Functional outcome assessed using the Grace and Eversmann scoring system. [6 months]

Secondary outcomes

Radiographic Bone Union Time [6 months]: the time until bridging callus is visible across at least 3 of 4 cortices on standard AP and lateral X-rays

+Eligibility

Sex: All, ages: 10 Years to 16 Years

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.

+Locations (1)

Facility	City	Country	Status
Faculty of medicine, Sohag university	Sohag	Egypt

+Investigators

ramadan moanes, Principal investigator, Faculty of medicine, Sohag university