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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07067333
Enrollment
100
Registered
2025-07-16
Start date
2025-08-01
Completion date
2026-04-01
Last updated
2025-07-16

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

Conditions

Shaft Femure Fracture in Adolescents

Brief 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.

Interventions

DEVICEintramedullary nails for group A

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

DEVICEplate for group B

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

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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Fracture Femure fixation by intramedullary nails versus plates6 monthslimb length discrepancy by planning X rays.

Countries

Egypt

Contacts

Primary ContactMohamed Hashem Ahmed, master
mohammed.hashem@med.sohag.edu.eg+2001097500949

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026