Role of Rotational Guided Growth in Management of Increased Femoral Anteversion

March 19, 2024 updated by: Ain Shams University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ahmed Mohamed Mohamed Abdelghany Badr, Msc
  • Phone Number: +201060085397
  • Email: abaghany@gmail.com

Study Contact Backup

  • Name: Tarek Hassan Abdelaziz
  • Phone Number: +201222421760

Study Locations

  • Egypt
    • El-Waily
      • Cairo, El-Waily, Egypt
        • Recruiting
        • Faculty of Medicine, Ainshams University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: Plate Technique
Using Plates, non-absorbable sutures or cerclage wires to guide the distal femoral physis towards rotational growth to correct deformity
Other Names:
  • Non-absorbable Suture Technique
  • Cerclage Wire Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait
Time Frame: 12 months
Foot Progression Angle 5-10 degrees by clinical gait assesment
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Limb length discrepancy
Time Frame: 12 months
Difference between length of both limbs through clinical measurement
12 months
Angular Deformities
Time Frame: 12 months
CR radiographic measuement including angles such as MPTA, LDFA
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: Tarek Hassan Abdelaziz, Professor, ain shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

February 23, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 24101994

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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