Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05334862

Residual Torsional Deformity in Pediatric Genu Varum After Coronal Plane Deformity Correction by 8 Plate Hemi Epiphysiodesis.

This study is to evaluate the residual torsional deformity in pediatric Genu Varum after coronal plane deformity correction by 8 plate hemi epiphysiodesis.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

30 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University Hospital

Asyut, Asyut Governorate, 71511, Egypt

Location status: Recruiting

Location contact

Hesham Elbaseet, professor

CONTACT

Mohammed Elsharkawy, head of orthopaedic department

CONTACT

[email protected]

+201005075855

About this study

Angular deformities around the knee in children is a common finding including genu valgum and genu varum.

The genu valgum or varum may be idiopathic or arise from diverse etiologies, such as trauma, dysplasia, metabolic disease, inflammatory, endocrine, tumor, neoplastic, or developmental pathologies.

Surgical treatment options include osteotomies with either acute or gradual correction and temporary hemi epiphysiodesis (guided growth),the latter being less invasive and with significantly lower rate of major complications.

Guided growth by 8 plate hemi epiphysiodesis is commonly used to correct coronal plane deformity around the knee. Since its introduction by Stevens in 2007 many studies have demonstrated the efficacy, safety and advantages of tension band plating in the paediatric age group as an alternative to corrective osteotomy.

Genu varum deformities of the leg are often associated with internal tibial torsion. The 3 major causes of pediatric in-toeing are metatarsus adductus, internal tibial torsion, and femoral anteversion.

..yet, there is no enough available literature studies evaluating the amount of correction of torsional deformity after coronal plane deformity correction by 8 plate hemi epiphysiodesis.

This is the question of this study and we are trying to answer it by measuring the residual torsional deformity after achieving full correction of coronal plane deformity by 8 plate hemi epiphysiodesis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion criteria: skeletally immature patients over 2.5 years of age and less than 12 years of age who presented with genu varum. (unilateral or bilateral)
  • Exclusion criteria:
  • skeletal maturity.
  • epiphyseal dysplasia.
  • metabolic and neurologic disorders.
  • previous trauma.
  • patients younger than 2.5 years and older than 12 years old

Treatment and study plan

8 plate hemiepiphysiodesis

Procedure

surgical procedure by lateral incision in proximal tibia and distal femur and fixation by using 8 plate and screws.

Primary outcomes

  1. residual torsional deformity measured via clinical examination.

    Time frame: 1 year

    clinical examination by measuring : thigh foot angle - foot progression angle - heel bisector - internal and external rotaion of the hip

Secondary outcomes

  1. Any complications detected

    Time frame: 1 year

    Follow up of the patient postoperatively and clinical examination. Number of participants with any complications

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Boles, Resident doctor

CONTACT

[email protected]

01225078186

Hesham Elbaseet, Doctor

CONTACT

[email protected]

01007780689

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 19, 2022
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.