An interventional study of Tension Band Plate (TBP) Surgery and Percutaneous Epiphysiodesis by Transphyseal Screw (PETS) Surgery in Epiphysiodesis, Bone Malalignment and Lower Extremity Deformities, Congenital, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 7 Years to 16 Years. Per ClinicalTrials.gov, last updated 2025-03-17.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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:
Participants will:
Researchers will compare TBP and PETS groups to see if one method leads to better deformity correction and fewer complications.
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 for modulating growth and gradually correcting these deformities is temporary Hemi-epiphysiodesis. The two most commonly used techniques for this purpose are the Tension Band Plate (TBP) e.g. Eight-Plate and Percutaneous Epiphysiodesis using Transphyseal Screws (PETS). While both methods have proven effective, there remains ongoing debate about their relative efficacy, safety, and long-term outcomes.
The TBP technique, introduced as a less invasive method of guided growth, involves placing a non-locking plate and screws across the growth plate on one side allowing controlled correction without permanent damage to the physis.
Studies have demonstrated its effectiveness in treating angular deformities with a lower risk of growth plate closure, but concerns remain regarding implant migration, breakage, and rebound deformity post-removal. Conversely, PETS offers a minimally invasive alternative where transphyseal screws modulate growth without requiring plate fixation. Some studies suggest PETS may provide more rapid correction with fewer complications, while others highlight the potential risk of premature physeal closure, which could lead to limb length discrepancies.
Despite the widespread use of both techniques, there is limited high-quality comparative data to determine the superior method in terms of correction rate, complication profile, and long-term functional outcomes. A randomized controlled study comparing TBP and PETS is essential to establish evidence-based guidelines, optimize patient outcomes, and refine surgical decision-making in the management of genu varum and genu valgum. Our novel introduction of the Bone-Length Adjusted Correction Rate as a new criterion will further enhance the measurement of effectiveness for these interventions.
18 studies on the registry are indexed under Genu Varum; 8 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 12 interventional studies indexed under Genu Varum.
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Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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)
Participants in this group will undergo guided growth correction of coronal angular knee deformities using the Tension Band Plate (TBP) technique. A non-locking 8-plate is placed extraperiosteally across the growth plate with two screws to modulate bone growth gradually. This technique allows controlled correction without permanently damaging the physis and is commonly used for treating genu valgum and genu varum.
Procedure: Tension Band Plate (TBP) Surgery
Participants in this group will undergo guided growth correction using Percutaneous Epiphysiodesis by Transphyseal Screw (PETS). This involves inserting a partially threaded cannulated screw across the growth plate to slow down growth on one side of the bone, achieving gradual angular correction. PETS is a minimally invasive alternative to TBP and has been associated with faster correction rates.
Procedure: Percutaneous Epiphysiodesis by Transphyseal Screw (PETS) 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.
Also known as: Guided Growth with Tension Band Plate, Extraperiosteal Growth Modulation with 8-Plate, Temporary Hemi-epiphysiodesis with Tension Band Plate, 8-Plate Hemi-epiphysiodesis
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.
Also known as: Transphyseal Screw Epiphysiodesis, Growth Modulation with Transphyseal Screw, Minimally Invasive Epiphysiodesis with Screw
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
Time frame: Measured at 3-month intervals until clinical correction is achieved, up to 12 months
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.
Time frame: Measured at 3-month intervals until clinical correction is achieved, up to 12 months
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.
Time frame: Evaluated at each follow-up visit (3, 6, 9, 12 months)
Plan to share: No
Start is estimated for Apr 2025; primary completion for Apr 2027, 24 months later.
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