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Management of Diaphyseal Forearm Fractures in Adolescents

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07705347
Enrollment
20
Registered
2026-07-15
Start date
2026-07-15
Completion date
2027-06-01
Last updated
2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Forearm Fractures

Keywords

Diaphyseal forearm fractures in adolescents

Brief 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

Interventions

PROCEDUREOpen 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.

PROCEDUREClosed or mini-open reduction and fixation

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

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 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.

Design outcomes

Primary

MeasureTime frame
Functional outcome assessed using the Grace and Eversmann scoring system.6 months

Secondary

MeasureTime frameDescription
Radiographic Bone Union Time6 monthsthe time until bridging callus is visible across at least 3 of 4 cortices on standard AP and lateral X-rays

Countries

Egypt

Contacts

CONTACTRamadan Moanes
ramadanmoanes@gmail.com+201068323176
PRINCIPAL_INVESTIGATORramadan moanes

Faculty of medicine, Sohag university

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 16, 2026