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

NCT ID: NCT06630975

Last Updated: 2024-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-25

Study Completion Date

2025-10-01

Brief Summary

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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

Detailed Description

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Eight-Plates first described by Stevens are simple to use .Moreover, owing to the flexible screw/plate connection, fewer complications in terms of implant loosening and fracture can be expected.Good results aswell as low reboundand complication rates have been recorded for the first series of cases

Conditions

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Genu Varum

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Comparative Study between Growth guided Correction By ( 8 Plate )

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

Group Type EXPERIMENTAL

Hemiepiphysiodesis

Intervention Type DEVICE

8 plate

Eight-Plates first described by Stevens are simple to use

Intervention Type 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

Hemiepiphysiodesis by eight Plate

Intervention Type DEVICE

Extraperiosteal eight plate insertion

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

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

Group Type OTHER

Hemiepiphysiodesis

Intervention Type DEVICE

8 plate

Eight-Plates first described by Stevens are simple to use

Intervention Type 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

Hemiepiphysiodesis by eight Plate

Intervention Type DEVICE

Extraperiosteal eight plate insertion

Comparison the Result of Growth guided Correction to Osteoclasis

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

Group Type ACTIVE_COMPARATOR

Hemiepiphysiodesis

Intervention Type DEVICE

8 plate

Eight-Plates first described by Stevens are simple to use

Intervention Type 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

Hemiepiphysiodesis by eight Plate

Intervention Type DEVICE

Extraperiosteal eight plate insertion

Genu Varum

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

Group Type ACTIVE_COMPARATOR

Hemiepiphysiodesis

Intervention Type DEVICE

8 plate

Eight-Plates first described by Stevens are simple to use

Intervention Type 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

Hemiepiphysiodesis by eight Plate

Intervention Type DEVICE

Extraperiosteal eight plate insertion

Interventions

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Hemiepiphysiodesis

8 plate

Intervention Type DEVICE

Eight-Plates first described by Stevens are simple to use

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

Intervention Type PROCEDURE

Hemiepiphysiodesis by eight Plate

Extraperiosteal eight plate insertion

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Growth plate still open at Time of Surgery

Exclusion Criteria

* Epiphyseal plate involved in trauma resulting in a bridging callus formation,
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Osama Hamdy

Mohamed Osama Hamdy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mohammad Osama Hamdy

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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‪mohamed Osama‬

Role: primary

01094394135

Ahmed Khashaba

Role: backup

01023233949

Other Identifiers

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HEPVOMPCKD

Identifier Type: -

Identifier Source: org_study_id

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