Fixation of Fracture Neck of Femur in Children

Fracture Neck of Femur Clinical Trial

Official title:

Fixation of Fracture Neck of Femur in Children by Cannulated Screws VS Wagner's Technique.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06267885
• Other study ID #: Children NOF fracture fixation
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: March 2026

Study information

• Verified date: February 2024
• Source: Assiut University
• Contact: Mina Maged, Resident
• Phone: 01205188908
• Email: Menamaged54[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Find the best way for fixation of fracture neck of femur in children either by cannulated screws or wagner's technique

Description:

In the pediatric population, fracture of the neck of femur is relatively uncommon usually caused by high-energy trauma, but with high complication rates, despite appropriate diagnosis and management. The high rate of complication is due to the vascular anatomy of proximal femur. Fracture neck of femur can be classified into transphyseal , transcervical (which is commonest), basal and pertrochanteric. Complications include avascular necrosis, delayed union and non-union. Multiple fracture fixation methods have been used, with the overall goal being anatomic reduction with stable fixation. Methods of fixation vary based on age, Delbet classification and dispalcement of the fracture. Two types of fixation of pediatric fracture NOF of interest are cannulated screw (CS) and the Wagner technique. Most studies agree that 3 screws are enough, and they should be inserted parallel in triangular arrangement with an inverted triangle. The CS should apply compression to the fracture (compression screws) to minimize the remaining fracture gap and accelerate the healing process. The use of washers allows for higher compression forces and thus increases the initial stabilization. CS shouldn't pass the physis in pediatrics to allow normal continuation of growth in children. The stability of fixation by CS has been shown to be affected by several factors: screw type, number, thickness, position and direction. Some of CS disadvantages are that they are mechanically unstable, failure of stabilization leads to varus malunion and it may lead to slipped capital femora epiphysis (SCFE) above the tips of the screws(especially short working distance in transcervical fractures). The Wagner technique consists of the use of two or three k-wires bent as close as possible to the shaft and fixed to the shaft by two cerclage wires. Some advantages of this method are that k-wires can cross the physis and give good stability to the fracture with normal continuation of growth(especially in transphyseal & transcerviacal fractures). Hip spica is recommended to give more stabilization to the fixation and neutralize forces around the fixed fracture.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: March 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 14 Years

Eligibility

Inclusion Criteria:

• clinical diagnosis of fracture neck of femur
• children with age less than 14 years old

Exclusion Criteria:

• pathological fracture
• patients with cerebral palsy
• Associated ipsilateral femoral shaft fracture
• comminuted fractures
• old fracture ( > 2 weeks)

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fracture Neck of Femur
• Fractures, Bone

Intervention

Procedure:
• Cannulated screws vs wagner's technique
Fixation of fracture neck of femur by cannulated screws or wagner's technique

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The better method for fixation of fracture neck of femur	The rate of cases with complications with avascular necrosis in each method	Baseline, one year