Fixation of Fracture Neck of Femur in Children

NCT ID: NCT06267885

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-31

Study Completion Date

2026-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Fracture Neck of Femur

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Patients with fracture neck of femur fixed by cannulated screws

Fix the fracture by two to three cannulatef screws

Group Type ACTIVE_COMPARATOR

Cannulated screws vs wagner's technique

Intervention Type PROCEDURE

Fixation of fracture neck of femur by cannulated screws or wagner's technique

Patient with fracture neck of femur fixed by wagner's technique

Fix the fracture by three to four k-wires

Group Type ACTIVE_COMPARATOR

Cannulated screws vs wagner's technique

Intervention Type PROCEDURE

Fixation of fracture neck of femur by cannulated screws or wagner's technique

Interventions

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Cannulated screws vs wagner's technique

Fixation of fracture neck of femur by cannulated screws or wagner's technique

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

1 Year

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mina Maged

Resident in assiut university hospital , orthopaedic department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut university

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Mina Maged, Resident

Role: CONTACT

01205188908

Hesham Mohammed, Staff member doctor

Role: CONTACT

01007780689

Facility Contacts

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Mina Maged

Role: primary

Other Identifiers

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Children NOF fracture fixation

Identifier Type: -

Identifier Source: org_study_id

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