Hemiepiphysiodesis by Eight Plate Versus Osteotomy in the Management of Pediatric Coronal Knee Deformities

NCT06630975 | Recruiting DMC

• 1 other identifier: HEPVOMPCKD
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Coronal angular deformities of lower limb in children are a common finding in pediatric orthopedic surgery.These angular deformities can be idiopathic in origin, or they can emerge secondary to congenital and acquired abnormalities. Persistent coronal plane deformities around knee (genu varum/valgum) could lead to meniscal tears, collateral ligament laxity, cartilage degeneration, and early osteoarthritis due to gradual mechanical axis disruption

Conditions

Genu Varum

Outcome Measures

Primary Outcomes (1)

• Comparative Study Between Growth Guided Correction By ( 8 Plate ) and Corrective Osteoclasis in Management of Coronal Deformity of Lower Limb in Children

  Coronal angular deformities of lower limb in children are a common finding in pediatric orthopedic surgery.These angular deformities can be idiopathic in origin, or they can emerge secondary to congenital and acquired abnormalities. Persistent coronal plane deformities around knee (genu varum/valgum) could lead to meniscal tears, collateral ligament laxity, cartilage degeneration, and early osteoarthritis due to gradual mechanical axis disruption

  1 year

Study Arms (4)

Comparative Study between Growth guided Correction By ( 8 Plate )

EXPERIMENTAL

Coronal angular deformities of lower limb in children are a common finding in pediatric orthopedic surgery.

Device: Hemiepiphysiodesis; Procedure: Eight-Plates first described by Stevens are simple to use; Device: Hemiepiphysiodesis by eight Plate

Clinical ,Radiological of Comparison the Result of Growth guided Correction to Osteoclasis in mana

OTHER

These angular deformities can be idiopathic in origin, or they can emerge secondary to congenital and acquired abnormalities. Valgus deformities in excess of 10\* can cause anterior knee pain, circumduction gait, and occasionally patellofemoral instability. Varus deformities may result in lateral thrust, ligamentous laxity, and a waddling gait , meniscal tears, collateral ligament laxity, cartilage degeneration, and early osteoarthritis due to gradual mechanical axis disruption

Device: Hemiepiphysiodesis; Procedure: Eight-Plates first described by Stevens are simple to use; Device: Hemiepiphysiodesis by eight Plate

Comparison the Result of Growth guided Correction to Osteoclasis

ACTIVE COMPARATOR

These angular deformities can be idiopathic in origin, or they can emerge secondary to congenital and acquired abnormalities. Valgus deformities in excess of 10\* can cause anterior knee pain, circumduction gait, and occasionally patellofemoral instability. Varus deformities may result in lateral thrust, ligamentous laxity, and a waddling gait , meniscal tears, collateral ligament laxity, cartilage degeneration, and early osteoarthritis due to gradual mechanical axis disruption

Device: Hemiepiphysiodesis; Procedure: Eight-Plates first described by Stevens are simple to use; Device: Hemiepiphysiodesis by eight Plate

Genu Varum

ACTIVE COMPARATOR

These angular deformities can be idiopathic in origin, or they can emerge secondary to congenital and acquired abnormalities. Valgus deformities in excess of 10\* can cause anterior knee pain, circumduction gait, and occasionally patellofemoral instability. Varus deformities may result in lateral thrust, ligamentous laxity, and a waddling gait , meniscal tears, collateral ligament laxity, cartilage degeneration, and early osteoarthritis due to gradual mechanical axis disruption

Device: Hemiepiphysiodesis; Procedure: Eight-Plates first described by Stevens are simple to use; Device: Hemiepiphysiodesis by eight Plate

Interventions

Hemiepiphysiodesis DEVICE

8 plate

Clinical ,Radiological of Comparison the Result of Growth guided Correction to Osteoclasis in mana; Comparative Study between Growth guided Correction By ( 8 Plate ); Comparison the Result of Growth guided Correction to Osteoclasis; Genu Varum

Eight-Plates first described by Stevens are simple to use PROCEDURE

fewer complications in terms of implant loosening and fracture can be expected.Good results as well as low rebound and complication rates have been recorded

Clinical ,Radiological of Comparison the Result of Growth guided Correction to Osteoclasis in mana; Comparative Study between Growth guided Correction By ( 8 Plate ); Comparison the Result of Growth guided Correction to Osteoclasis; Genu Varum

Hemiepiphysiodesis by eight Plate DEVICE

Extraperiosteal eight plate insertion

Clinical ,Radiological of Comparison the Result of Growth guided Correction to Osteoclasis in mana; Comparative Study between Growth guided Correction By ( 8 Plate ); Comparison the Result of Growth guided Correction to Osteoclasis; Genu Varum

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Growth plate still open at Time of Surgery

You may not qualify if:

• Epiphyseal plate involved in trauma resulting in a bridging callus formation,

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Mohammad Osama Hamdy

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Genu Varum

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mohamed Osama Hamdy

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 8, 2024
• Study Start: September 25, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

EG (1)