Fixation of Shaft Femure Fracrture by Ender Versus Plate

Sohag University

Status: Not yet enrolling

Conditions: Shaft Femure Fracture in Adolescents

Treatments: Device: intramedullary nails for group A; Device: plate for group B

Study type: Interventional

Funder types: Other

Identifiers

NCT07067333

Soh-Med--25-5-4MS

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 10 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

group A for intramadullary nail

Active Comparator group

Description:

fixation of the femure in group A by intramedullary nails

Treatment:

Device: intramedullary nails for group A

group B for plating

Active Comparator group

Description:

fixation of the shaft femure fracture in group B by plates

Treatment:

Device: plate for group B