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NCT Number: NCT06879015

Plate vs. Screw for Guided Growth in Coronal Knee Deformities

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.

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Key information

Age range

7 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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)

Treatment and study plan

Tension Band Plate (TBP) Surgery

Procedure

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.

Other names: Guided Growth with Tension Band Plate, Extraperiosteal Growth Modulation with 8-Plate, Temporary Hemi-epiphysiodesis with Tension Band Plate, 8-Plate Hemi-epiphysiodesis

Percutaneous Epiphysiodesis by Transphyseal Screw (PETS) Surgery

Procedure

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.

Other names: Transphyseal Screw Epiphysiodesis, Growth Modulation with Transphyseal Screw, Minimally Invasive Epiphysiodesis with Screw

Primary outcomes

  1. Bone-Length Adjusted Angular Correction Rate (BLAACR)

    Time frame: 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

Secondary outcomes

  1. Angular Correction Rate (Degrees/Month)

    Time frame: Measured at 3-month intervals until clinical correction is achieved, up to 12 months

    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.

  2. Complications (Pain, Infection, Hardware Migration/Breakage)

    Time frame: Evaluated at each follow-up visit (3, 6, 9, 12 months)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed G Shazly, MBBCh

CONTACT

[email protected]

+201090503004

Nariman E Abol Oyoun, PhD

CONTACT

[email protected]

+201222302343

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: PETS vs TBP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 17, 2025
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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