Plate vs. Screw for Guided Growth in Coronal Knee Deformities (PETS vs TBP)

March 14, 2025 updated by: Mohamed Gamal Abdelghany Shazly, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tension Band Plate (TBP) Group
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
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
Active Comparator: Percutaneous Epiphysiodesis by Transphyseal Screw (PETS) Group
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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured at 3-month intervals until clinical correction is achieved, up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured at 3-month intervals until clinical correction is achieved, up to 12 months
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.
Evaluated at each follow-up visit (3, 6, 9, 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 14, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-2025-201192

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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