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

NCT05334862 | Recruiting DMC

• 1 other identifier: 8 plate in genu varum
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Paediatric Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Any complications detected

  1 year

Study Arms (1)

skeletally immature patients between 2.5 : 12 years with genu varum

ACTIVE COMPARATOR

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

Interventions

8 plate hemiepiphysiodesis PROCEDURE

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

skeletally immature patients between 2.5 : 12 years with genu varum

Eligibility Criteria

• Age: 30 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• skeletal maturity.
• epiphyseal dysplasia.
• metabolic and neurologic disorders.
• previous trauma.
• patients younger than 2.5 years and older than 12 years old

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Asyut Governorate, 71511, Egypt

RECRUITING

Related Publications (2)

• 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.

  PMID: 8073465 BACKGROUND

• 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.

  PMID: 5072935 BACKGROUND

Study Officials

• Hesham Elbaseet, Doctor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Andrew Boles, Resident doctor

CONTACT

01225078186; andrewandrew44444@gmail.com

Hesham Elbaseet, Doctor

CONTACT

01007780689; Drhesham20@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor, Orthopaedic surgery department, Principal investigator

Model Details: skeletally immature patients over 2.5 years of age and less than 12 years of age who presented with genu varum. (unilateral or bilateral)

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 19, 2022
• Study Start: January 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: from october 2025
• Access Criteria: anyone

Locations

EG (1)