NCT07067333

Fixation of Shaft Femure Fracrture by Ender Versus Plate

Elastic Intramedullary Nails Versus Plate Fixation in Treatment of Diaphyseal Femoral Fracture in Adolescent

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sohag University · Academic / Other
• Sex: All
• Age: 10 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare the * functional outcomes, fracture healing time, rate of complications, and long-term growth outcomes between intramedullary nail and plating in adolescent. * Assess radiographic outcomes (e.g., alignment, limb length discrepancy, and growth plate disturbance). * Evaluate complications such as infection, nonunion, malunion, refractures, and need for reoperation (e.g., hardware removal).

Detailed description

Elastic Nails (EN) are flexible intramedullary devices, usually made of titanium or stainless steel, that allow for dynamic stabilization. They are typically used for fractures in children and adolescents. The intramedullary nails offer the advantage of minimally invasive insertion, less disruption of the periosteum, and potential for less disruption of the growth plate.The nails bend and allow for some motion at the fracture site, which promotes healing through the formation of callus. Plate fixation typically involves a compression or neutralization plate, usually a dynamic compression plate (DCP) or a locking plate. This method provides rigid stabilization but often requires more extensive dissection and can interfere with growth if the plate is applied too close to the physis (growth plate).While plating can be very effective in providing stability, there is a higher risk of complications such as hardware-related issues (e.g., plate prominence, need for removal) and potential growth disturbances.

Conditions

• Shaft Femure Fracture in Adolescents

Interventions

Type	Name	Description
DEVICE	intramedullary nails for group A	fixation of the shaft femure fracture in this group by intramedullary nails
DEVICE	plate for group B	fixation of the shaft femure fracture in the group b by plates

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2025-07-16
• Last updated: 2025-07-16

Locations

1 site across 1 country: Egypt