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EpiphysiodesisPETS vs TBPNCT06879015

Plate vs. Screw for Guided Growth in Coronal Knee Deformities

A study testing Tension Band Plate (TBP) Surgery and Percutaneous Epiphysiodesis by Transphyseal Screw (PETS) Surgery in people with Epiphysiodesis and Bone Malalignment, run by Assiut University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 16 years
What is being tested?
Tension Band Plate (TBP) Surgery and Percutaneous Epiphysiodesis by Transphyseal Screw (PETS) Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Apr 2025to 1 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mohamed G Shazly, MBBCh contact

+201090503004

mohamed.shazly@med.aun.edu.eg

Nariman E Abol Oyoun, PhD contact

+201222302343

n.aboloyoun@aun.edu.eg

Egypt1 site
  • Assiut University Hospital

    Asyut, 71525

    Mohamed K Ahmed, PhD, +201026161155, mohamed.khaled@aun.edu.eg

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

Being tested
Tension Band Plate (TBP) Surgery, Percutaneous Epiphysiodesis by Transphyseal Screw (PETS) Surgery
Keywords
Guided Growth, Growth Modulation, Tension Band Plate, Percutaneous Epiphysiodesis by Transphyseal Screw
Medical subject headings
Bone Malalignment, Lower Extremity Deformities, Congenital, Genu Varum, Genu Valgum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tension Band Plate (TBP) SurgeryProcedure or surgery

    Also called Guided Growth with Tension Band Plate, Extraperiosteal Growth Modulation with 8-Plate, Temporary Hemi-epiphysiodesis with Tension Band Plate, 8-Plate Hemi-epiphysiodesis

    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) SurgeryProcedure or surgery

    Also called Transphyseal Screw Epiphysiodesis, Growth Modulation with Transphyseal Screw, Minimally Invasive Epiphysiodesis with Screw

    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.

Study groups in NCT06879015
Study groupRoleWhat they receive
Tension Band Plate (TBP) GroupActive comparatorParticipants 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.
Receives: Procedure: Tension Band Plate (TBP) Surgery
Percutaneous Epiphysiodesis by Transphyseal Screw (PETS) GroupActive comparatorParticipants 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.
Receives: Procedure: Percutaneous Epiphysiodesis by Transphyseal Screw (PETS) Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

Secondary outcomes (2)
  1. 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.

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

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2025
  2. Study start1 Apr 2025 (estimated)
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are randomized into two groups, each receiving one of the two interventions (Tension Band Plate or Percutaneous Epiphysiodesis by Transphyseal Screw).
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06879015
Sponsor's protocol ID
04-2025-201192
Acronym
PETS vs TBP
Status last verified
Mar 2025
First submitted
11 Mar 2025
Last updated
17 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Janarv PM, Wikstrom B, Hirsch G. The influence of transphyseal drilling and tendon grafting on bone growth: an experimental study in the rabbit. J Pediatr Orthop. 1998 Mar-Apr;18(2):149-54.

    PubMed 9531394
  • Tirta M, Hjorth MH, Jepsen JF, Kold S, Rahbek O. Staples, tension-band plates, and percutaneous epiphysiodesis screws used for leg-length discrepancy treatment: a systematic review and proportional meta-analysis. Acta Orthop. 2024 Jul 18;95:415-424. doi: 10.2340/17453674.2024.41104.

    PubMed 39023429
  • 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.

    PubMed 24322536
  • Ilharreborde B, Gaumetou E, Souchet P, Fitoussi F, Presedo A, Pennecot GF, Mazda K. Efficacy and late complications of percutaneous epiphysiodesis with transphyseal screws. J Bone Joint Surg Br. 2012 Feb;94(2):270-5. doi: 10.1302/0301-620X.94B2.27470.

    PubMed 22323699
  • Park BK, Kim HW, Park H, Lee SK, Park KB. Natural behaviours after guided growth for idiopathic genu valgum correction: comparison between percutaneous transphyseal screw and tension-band plate. BMC Musculoskelet Disord. 2022 Dec 3;23(1):1052. doi: 10.1186/s12891-022-05996-1.

    PubMed 36461004
  • Shapiro G, Adato T, Paz S, Shrabaty T, Ron L, Simanovsky N, Zaidman M, Goldman V. Hemiepiphysiodesis for coronal angular knee deformities: tension-band plate versus percutaneous transphyseal screw. Arch Orthop Trauma Surg. 2022 Jan;142(1):105-113. doi: 10.1007/s00402-020-03602-4. Epub 2020 Sep 21.

    PubMed 32959086
  • Eastwood DM, Sanghrajka AP. Guided growth: recent advances in a deep-rooted concept. J Bone Joint Surg Br. 2011 Jan;93(1):12-8. doi: 10.1302/0301-620X.93B1.25181.

    PubMed 21196537
  • Stevens PM, Klatt JB. Guided growth for pathological physes: radiographic improvement during realignment. J Pediatr Orthop. 2008 Sep;28(6):632-9. doi: 10.1097/BPO.0b013e3181841fda.

    PubMed 18724199
  • Khoury JG, Tavares JO, McConnell S, Zeiders G, Sanders JO. Results of screw epiphysiodesis for the treatment of limb length discrepancy and angular deformity. J Pediatr Orthop. 2007 Sep;27(6):623-8. doi: 10.1097/BPO.0b013e318093f4f4.

    PubMed 17717460
  • 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.

    PubMed 22654982
  • 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.

    PubMed 9600565

Questions about this trial

What is this clinical trial studying?

A study testing Tension Band Plate (TBP) Surgery and Percutaneous Epiphysiodesis by Transphyseal Screw (PETS) Surgery in people with Epiphysiodesis and Bone Malalignment, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mohamed G Shazly, MBBCh (+201090503004, mohamed.shazly@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bone-Length Adjusted Angular Correction Rate (BLAACR) (time frame: Measured at 3-month intervals until clinical correction is achieved, up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06879015, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.

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