Clinical trial NCT05334862: Residual Torsional Deformity in Pediatric Genu Varum After Coronal Plane Deformity Correction by 8 Plate Hemi Epiphysiodesis.
Official title: Residual Torsional Deformity in Pediatric Genu Varum After Coronal Plane Deformity Correction by 8 Plate Hemi Epiphysiodesis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Paediatric Surgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 15
Sex: ALL
Minimum age (years): 30
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: skeletally immature patients over 2.5 years of age and less than 12 years of age who presented with genu varum. (unilateral or bilateral)
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: - 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

Primary outcomes:
measure: residual torsional deformity measured via clinical examination.
timeFrame: 1 year
Secondary outcomes:
measure: Any complications detected
timeFrame: 1 year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
affiliation: Assiut University
name: Hesham Elbaseet, Doctor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.