About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Sick Physis as in Blount's disease stages III-V or any partial or total physeal arrest caused by trauma, inflammation or neoplasia.
Trial design
Parallel
Treatments tested in this trial
Tension Band Plate (TBP) Surgery
Procedure/SurgeryA 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
Procedure/SurgeryA 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.
Treatment groups
Trial outcomes
Primary outcomes
Bone-Length Adjusted Angular Correction Rate (BLAACR)
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
Secondary outcomes
Angular Correction Rate (Degrees/Month)
Measures the rate of angular deformity correction over time without adjusting for bone growth. This is calculated as: (Initial Angle - Final Angle) / Total Months of Follow-up.
Complications (Pain, Infection, Hardware Migration/Breakage)
Assess the frequency and severity of complications related to TBP and PETS, including post-operative pain (measured using a visual analog scale), surgical site infections, implant migration, and hardware failure.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: