Management of Diaphyseal Forearm Fractures in Adolescents

ConditionForearm Fractures

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age10-16

SponsorSohag University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age: 10 to 16 years (at time of injury).

Fracture pattern: diaphyseal fracture involving both the radius or ulna.

Angulation > 15° in any plane (sagittal or frontal).

Translation > 50% of bone diameter.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: Group (plate)Active comparator 1 intervention

Group B: Group (TENs)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Functional outcome assessed using the Grace and Eversmann scoring system.

Time frame

6 months

Secondary outcomes

Radiographic Bone Union Time

the time until bridging callus is visible across at least 3 of 4 cortices on standard AP and lateral X-rays

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sohag University

Lead sponsor

Source ClinicalTrials.gov

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