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Starting soon Not applicable

Plate vs. Screw for Guided Growth in Coronal Knee Deformities

NCT06879015 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-04-01
Last updated
2025-03-17

Condition(s) studied

EpiphysiodesisBone MalalignmentLower Extremity Deformities, CongenitalGenu VarumGenu Valgum

Investigational drug(s) / intervention(s)

Tension Band Plate (TBP) SurgeryPercutaneous Epiphysiodesis by Transphyseal Screw (PETS) Surgery

Tension Band Plate (TBP) Surgery: A guided growth procedure in which a non-locking 8-plate is placed extraperiosteally across the physis (growth plate) with two screws, one in the epiphysis and one in the metaphysis. This allows for gradual correction of coronal angular deformities without causing permanent growth arrest.

Percutaneous Epiphysiodesis by Transphyseal Screw (PETS) Surgery: A minimally invasive procedure in which a partially threaded cannulated screw is inserted across the growth plate (transphyseal) to slow growth on one side of the bone. This technique allows for gradual correction of genu valgum and genu varum.

Study 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 deformities.

The main questions it aims to answer are:

* Which technique provides better correction of coronal knee deformities?
* Are there differences in complication rates or recovery times between TBP and PETS?

Participants will:

* Undergo either TBP or PETS surgery for knee deformity correction.
* Attend follow-up visits for radiographic and clinical evaluations.

Researchers will compare TBP and PETS groups to see if one method leads to better deformity correction and fewer complications.

Eligibility

Sex
ALL
Min age
7 Years
Max age
16 Years
Healthy volunteers
No
Inclusion Criteria: 1. 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. 2. 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 Criteria: 1. Sick Physis as in Blount's disease stages III-V or any partial or total physeal arrest caused by trauma, inflammation or neoplasia. 2. 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)

Primary outcome measure(s)

  • Bone-Length Adjusted Angular Correction Rate (BLAACR) — Measured at 3-month intervals until clinical correction is achieved, up to 12 months
    The Bone-Length Adjusted Angular Correction Rate (BLAACR) measures the effectiveness of guided growth correction by normalizing the angular correction rate based on limb growth. This method reduces bias in comparing the Tension Band Plate (TBP) and Percutaneous Epiphysiodesis by Transphyseal Screw (PETS) by accounting for variations in growth rate among participants. The formula is: BLAACR = (Change in Angular Deformity) / (Increase in Bone Length), where: -- Change in Angular Deformity = Initial Angle - Final Angle * Increase in Bone Length = Initial Bone Length - Final Bone Length

Trial sites (1)

FacilityCityRegionStatus
Assiut University Hospital Asyut Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06879015 on ClinicalTrials.gov ↗ ← All trials in Egypt