Role of Rotational Guided Growth in Management of Increased Femoral Anteversion

Not Applicable

Recruiting

• Conditions: Increased Femoral Anteversion
• Interventions: Device: Plate Technique

• Registration Number: NCT06320769
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-02-20
• Study First Submitted: 2024-02-23
• Study First Submitted QC: 2024-03-19
• Last Update Submitted: 2024-03-19
• Study First Posted: 2024-03-20
• Last Update Posted: 2024-03-20
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rotational Guided Growth	Plate Technique	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

Primary Outcome Measures

Name	Time	Method
Gait	12 months	Foot Progression Angle 5-10 degrees by clinical gait assesment

Secondary Outcome Measures

Name	Time	Method
Angular Deformities	12 months	CR radiographic measuement including angles such as MPTA, LDFA
Limb length discrepancy	12 months	Difference between length of both limbs through clinical measurement

Trial Locations

Locations (1)

Faculty of Medicine, Ainshams University; 🇪🇬 Cairo, El-Waily, Egypt