Plate vs. Screw for Guided Growth in Coronal Knee Deformities

NCT06879015 | Not Yet Recruiting DMC

• 1 other identifier: 04-2025-201192
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Guided Growth; Growth Modulation; Tension Band Plate; Percutaneous Epiphysiodesis by Transphyseal Screw

Outcome Measures

Primary Outcomes (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 at 3-month intervals until clinical correction is achieved, up to 12 months

Secondary Outcomes (2)

• Angular Correction Rate (Degrees/Month)

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

• Complications (Pain, Infection, Hardware Migration/Breakage)

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

Study Arms (2)

Tension Band Plate (TBP) Group

ACTIVE COMPARATOR

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

Percutaneous Epiphysiodesis by Transphyseal Screw (PETS) Group

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Guided Growth with Tension Band Plate, Extraperiosteal Growth Modulation with 8-Plate, Temporary Hemi-epiphysiodesis with Tension Band Plate, 8-Plate Hemi-epiphysiodesis

Tension Band Plate (TBP) Group

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.

Also known as: Transphyseal Screw Epiphysiodesis, Growth Modulation with Transphyseal Screw, Minimally Invasive Epiphysiodesis with Screw

Percutaneous Epiphysiodesis by Transphyseal Screw (PETS) Group

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, 71525, Egypt

Location

Related Publications (11)

• 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.

  PMID: 9531394 BACKGROUND

• 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.

  PMID: 39023429 BACKGROUND

• 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.

  PMID: 24322536 BACKGROUND

• 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.

  PMID: 22323699 BACKGROUND

• 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.

  PMID: 36461004 BACKGROUND

• 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.

  PMID: 32959086 BACKGROUND

• 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.

  PMID: 21196537 BACKGROUND

• 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.

  PMID: 18724199 BACKGROUND

• 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.

  PMID: 17717460 BACKGROUND

• 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.

  PMID: 22654982 BACKGROUND

• 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.

  PMID: 9600565 BACKGROUND

MeSH Terms

Conditions

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

Interventions

tributyl phosphate; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Mohamed G Shazly, MBBCh

CONTACT

+201090503004; mohamed.shazly@med.aun.edu.eg

Nariman E Abol Oyoun, PhD

CONTACT

+201222302343; n.aboloyoun@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Model Details: Participants are randomized into two groups, each receiving one of the two interventions (Tension Band Plate or Percutaneous Epiphysiodesis by Transphyseal Screw).

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)