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Not Yet RecruitingNCT06879015

Plate vs. Screw for Guided Growth in Coronal Knee Deformities

Tension Band Plate (TBP) vs Percutaneous Epiphysiodesis by Transphyseal Screw (PETS) in Coronal Angular Knee Deformities in Children: a Randomized Controlled Study

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
7 Years – 16 Years
Healthy volunteers
Not accepted

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.

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 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.

Conditions

Interventions

TypeNameDescription
PROCEDURETension Band Plate (TBP) 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.
PROCEDUREPercutaneous Epiphysiodesis by Transphyseal Screw (PETS) 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.

Timeline

Start date
2025-04-01
Primary completion
2027-04-01
Completion
2027-06-01
First posted
2025-03-17
Last updated
2025-03-17

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06879015. Inclusion in this directory is not an endorsement.

Plate vs. Screw for Guided Growth in Coronal Knee Deformities (NCT06879015) · Clinical Trials Directory