Plate vs. Screw for Guided Growth in Coronal Knee Deformities

NCT ID: NCT06879015

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2027-06-01

Brief 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

Epiphysiodesis; Bone Malalignment; Lower Extremity Deformities, Congenital; Genu Varum; Genu Valgum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Tension Band Plate (TBP) Surgery

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Percutaneous Epiphysiodesis by Transphyseal Screw (PETS) Surgery

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Guided Growth with Tension Band Plate; Extraperiosteal Growth Modulation with 8-Plate; Temporary Hemi-epiphysiodesis with Tension Band Plate; 8-Plate Hemi-epiphysiodesis; Transphyseal Screw Epiphysiodesis; Growth Modulation with Transphyseal Screw; Minimally Invasive Epiphysiodesis with Screw

Eligibility Criteria

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)

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Gamal Abdelghany Shazly

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University Hospital

Asyut, , Egypt

Countries

Egypt

Central Contacts

Mohamed G Shazly, MBBCh

Role: CONTACT

mohamed.shazly@med.aun.edu.eg

+201090503004

Nariman E Abol Oyoun, PhD

Role: CONTACT

n.aboloyoun@aun.edu.eg

+201222302343

Facility Contacts

Mohamed K Ahmed, PhD

Role: primary

mohamed.khaled@aun.edu.eg

+201026161155

References

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Reference Type: BACKGROUND

PMID: 9531394 (View on PubMed)

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Reference Type: BACKGROUND

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Schoenleber SJ, Iobst CA, Baitner A, Standard SC. The biomechanics of guided growth: does screw size, plate size, or screw configuration matter? J Pediatr Orthop B. 2014 Mar;23(2):122-5. doi: 10.1097/BPB.0000000000000026.

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 17717460 (View on PubMed)

Boero S, Michelis MB, Riganti S. Use of the eight-Plate for angular correction of knee deformities due to idiopathic and pathologic physis: initiating treatment according to etiology. J Child Orthop. 2011 Jun;5(3):209-16. doi: 10.1007/s11832-011-0344-4. Epub 2011 May 12.

Reference Type: BACKGROUND

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Metaizeau JP, Wong-Chung J, Bertrand H, Pasquier P. Percutaneous epiphysiodesis using transphyseal screws (PETS). J Pediatr Orthop. 1998 May-Jun;18(3):363-9.

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Other Identifiers

04-2025-201192

Identifier Type: -

Identifier Source: org_study_id