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NCT Number: NCT07067333

Fixation of Shaft Femure Fracrture by Ender Versus Plate

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).

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Key information

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag University Hospital

Sohag, Egypt

Location contact

Magdy M Amin, Professor

CONTACT

Mohamed Hashem Ahmed, master

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 10-16 years (skeletally immature, based on radiographic evidence of growth plates).
  • Diagnosis: Closed or open (Grade I) diaphyseal femoral fractures.
  • Fracture type: Simple transverse, short oblique, or spiral fractures (classified by the AO/OTA system or by the Müller classification).

Exclusion criteria

  • • Fractures with significant comminution or open fractures (Grade II or III).
  • Pathological fractures (e.g., secondary to bone disease).
  • Severe systemic conditions that may affect bone healing or postoperative recovery (e.g., metabolic bone diseases).
  • Patients with previous ipsilateral femur fractures or those requiring re-operation for non-union or malunion.

Treatment and study plan

intramedullary nails for group A

Device

fixation of the shaft femure fracture in this group by intramedullary nails

plate for group B

Device

fixation of the shaft femure fracture in the group b by plates

Primary outcomes

  1. Fracture Femure fixation by intramedullary nails versus plates

    Time frame: 6 months

    limb length discrepancy by planning X rays.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Hashem Ahmed, master

CONTACT

[email protected]

+2001097500949

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.