Status:
NOT_YET_RECRUITING
Plate vs. Screw for Guided Growth in Coronal Knee Deformities
Lead Sponsor:
Assiut University
Conditions:
Epiphysiodesis
Bone Malalignment
Eligibility:
All Genders
7-16 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to compare two surgical techniques, Tension Band Plate (TBP) and Percutaneous Epiphysiodesis by Transphyseal Screw (PETS), in children with coronal angular knee defo...
Detailed Description
Genu varum and genu valgum are common lower limb deformities observed in children and adolescents. These conditions often require guided growth techniques for correction. One widely accepted approach ...
Eligibility Criteria
Inclusion
- Children and adolescents beyond the age of physiological varus/valgus correction (i.e., typically ≥4 years for genu varum and ≥7 years for genu valgum) with Mechanical Axis Deviation (MAD) in lower limbs and abnormal joint orientation angles, in the coronal plane either femoral or tibial.
- Open physis (growth plate) on radiographs and at least one year of growth remaining before age of skeletal maturity (typically ≤14 years in females, ≤16 years in males).
Exclusion
- Sick Physis as in Blount's disease stages III-V or any partial or total physeal arrest caused by trauma, inflammation or neoplasia.
- Uncorrectable systemic disorders affecting bone growth and alignment, including but not limited to:
- i- Severe metabolic disorders (e.g., advanced rickets, hypophosphatasia, mucopolysaccharidoses) ii- Uncontrolled endocrine disorders (e.g., untreated hypothyroidism, growth hormone abnormalities) iii- Severe connective tissue disorders (e.g., osteogenesis imperfecta, advanced Ehlers-Danlos syndrome) iv- Chronic inflammatory or hematologic conditions that impair bone growth (e.g., severe juvenile idiopathic arthritis, advanced sickle cell disease)
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06879015
Start Date
April 1 2025
End Date
June 1 2027
Last Update
March 17 2025
Active Locations (1)
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1
Assiut University Hospital
Asyut, Egypt, 71525