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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06267885
Other study ID # Children NOF fracture fixation
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
See also
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Completed NCT04680572 - Functional Outcome After Arthroplasty N/A