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.

Study Overview

• Status: Recruiting
• Conditions: Paediatric Surgery
• Intervention / Treatment: Procedure: 8 plate hemiepiphysiodesis

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew Boles, Resident doctor; Phone Number: 01225078186; Email: andrewandrew44444@gmail.com
• Study Contact Backup: Name: Hesham Elbaseet, Doctor; Phone Number: 01007780689; Email: Drhesham20@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt, 71511
    • Recruiting
    • Assiut University Hospital
    • Contact: Mohammed Elsharkawy, head of orthopaedic department; Phone Number: +201005075855; Email: sharkoran@aun.edu.eg
    • Contact: Hesham Elbaseet, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

- 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:

1. skeletal maturity.
2. epiphyseal dysplasia.
3. metabolic and neurologic disorders.
4. previous trauma.
5. patients younger than 2.5 years and older than 12 years old

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: skeletally immature patients between 2.5 : 12 years with genu varum; skeletally immature patients over 2.5 years of age and less than 12 years of age who presented with genu varum. (unilateral or bilateral) ..those will be treated by 8 plate hemi epiphysiodesis.	Procedure: 8 plate hemiepiphysiodesis; surgical procedure by lateral incision in proximal tibia and distal femur and fixation by using 8 plate and screws.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
residual torsional deformity measured via clinical examination.	clinical examination by measuring : thigh foot angle - foot progression angle - heel bisector - internal and external rotaion of the hip	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any complications detected	Follow up of the patient postoperatively and clinical examination. Number of participants with any complications	1 year

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Hesham Elbaseet, Doctor, Assiut University

Publications and helpful links

General Publications

• Schleien CL, Eberle B, Shaffner DH, Koehler RC, Traystman RJ. Reduced blood-brain barrier permeability after cardiac arrest by conjugated superoxide dismutase and catalase in piglets. Stroke. 1994 Sep;25(9):1830-4; discussion 1834-5. doi: 10.1161/01.str.25.9.1830.
• Parzuchowski A, Winiarska K. [Cataract surgery in patients with pronounced disorders of general condition]. Klin Oczna. 1972;42(4):1032-7. No abstract available. Polish.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 25, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Congenital Abnormalities; Genu Varum
• Other Study ID Numbers: 8 plate in genu varum

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: only IPD used in the results publication
• IPD Sharing Time Frame: from october 2025
• IPD Sharing Access Criteria: anyone
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No