Fixation of Shaft Femure Fracrture by Ender Versus Plate

NCT ID: NCT07067333

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-04-01

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.

Conditions

Shaft Femure Fracture in Adolescents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group A for intramadullary nail

fixation of the femure in group A by intramedullary nails

Group Type: ACTIVE_COMPARATOR

intramedullary nails for group A

Intervention Type: DEVICE

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

group B for plating

fixation of the shaft femure fracture in group B by plates

Group Type: ACTIVE_COMPARATOR

plate for group B

Intervention Type: DEVICE

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

Interventions

intramedullary nails for group A

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

Intervention Type: DEVICE

plate for group B

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Hashem Ahmed

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag University Hospital

Sohag, , Egypt

Countries

Egypt

Central Contacts

Mohamed Hashem Ahmed, master

Role: CONTACT

mohammed.hashem@med.sohag.edu.eg

+2001097500949

Facility Contacts

Magdy M Amin, Professor

Role: primary

Other Identifiers

Soh-Med--25-5-4MS

Identifier Type: -

Identifier Source: org_study_id