Fixation of Fracture Neck of Femur in Children

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Fracture Neck of Femur
• Intervention / Treatment: Procedure: Cannulated screws vs wagner's technique

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mina Maged, Resident; Phone Number: 01205188908; Email: Menamaged54@gmail.com
• Study Contact Backup: Name: Hesham Mohammed, Staff member doctor; Phone Number: 01007780689; Email: Drhesham20@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut University
    • Contact: Mina Maged

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients with fracture neck of femur fixed by cannulated screws; Fix the fracture by two to three cannulatef screws	Procedure: Cannulated screws vs wagner's technique; Fixation of fracture neck of femur by cannulated screws or wagner's technique
Active Comparator: Patient with fracture neck of femur fixed by wagner's technique; Fix the fracture by three to four k-wires	Procedure: Cannulated screws vs wagner's technique; Fixation of fracture neck of femur by cannulated screws or wagner's technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 13, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Fractures, Bone; Femoral Neck Fractures
• Other Study ID Numbers: Children NOF fracture fixation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No