Role of Rotational Guided Growth in Management of Increased Femoral Anteversion

NCT ID: NCT06320769

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-20
• Study Completion Date: 2026-03-01

Brief Summary

Efficacy of guided growth in coronal plane deformity correction and limb length discrepancy has been well-established. Recently, studies have explored the validity of guided growth in correction of rotational deformity through a modified method of application.

This concept has been validated in animal studies, biomechanical studies and two limited human case series through different methods.

This study evaluates the efficacy of rotational guided growth in management of increased femoral anteversion using three different constructs.

Detailed Description

The purpose of this study is:

1. Evaluate the efficacy of different constructs in correcting increased femoral anteversion clinically and radiographically.

2. Asses possible complications of this new concept including LLD, undesired coronal, sagittal plane deformity and stiffness.

Conditions

Increased Femoral Anteversion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rotational Guided Growth

o On a radiolucent operating table with the child supine, a torniquet is applied. The limb is prepped and draped.

oA Kirschner wire is inserted in midsagittal plane of the distal femoral physis from medial to lateral under fluoroscopic guidance.

After the initial step, One of three Surgical techniques might be used according to surgeon preference and patient age:

• Plate technique
• Non-absorbable suture technique
• Cerclage wire technique

Group Type: EXPERIMENTAL

Plate Technique

Intervention Type: DEVICE

Using Plates, non-absorbable sutures or cerclage wires to guide the distal femoral physis towards rotational growth to correct deformity

Interventions

Plate Technique

Using Plates, non-absorbable sutures or cerclage wires to guide the distal femoral physis towards rotational growth to correct deformity

Intervention Type: DEVICE

Other Intervention Names

Non-absorbable Suture Technique; Cerclage Wire Technique

Eligibility Criteria

Inclusion Criteria

• Children with increased femoral anteversion causing in-toeing with decreased agility.
• Aged 8 years and above with at least two years of bone growth remaining.

Exclusion Criteria

• Any patient who underwent previous femoral osteotomy.
• Any patient with sick physis (skeletal dysplasias, post traumatic / post infective physeal damage, active rickets).
• Cerebral Palsy (CP) patients

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tarek Hassan Abdelaziz, Professor

Role: STUDY_CHAIR

Ain Shams University

Locations

Faculty of Medicine, Ainshams University

Cairo, El-Waily, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed Mohamed Mohamed Abdelghany Badr, Msc

Role: CONTACT

abaghany@gmail.com

+201060085397

Tarek Hassan Abdelaziz

Role: CONTACT

+201222421760

Facility Contacts

Tarek Hassan Abdelaziz, Professor

Role: primary

drtarekibrahim@gmail.com

+201222421760

Other Identifiers

24101994

Identifier Type: -

Identifier Source: org_study_id