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

October 5, 2024 updated by: Mohamed Osama Hamdy, Al-Azhar University

Resident at AlAzhar University Assuit

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Growth plate still open at Time of Surgery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Hemiepiphysiodesis
8 plate
Procedure: 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
Device: Hemiepiphysiodesis by eight Plate
Extraperiosteal eight plate insertion
Other: 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
Device: Hemiepiphysiodesis
8 plate
Procedure: 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
Device: Hemiepiphysiodesis by eight Plate
Extraperiosteal eight plate insertion
Active Comparator: 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
Device: Hemiepiphysiodesis
8 plate
Procedure: 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
Device: Hemiepiphysiodesis by eight Plate
Extraperiosteal eight plate insertion
Active Comparator: 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
Device: Hemiepiphysiodesis
8 plate
Procedure: 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
Device: Hemiepiphysiodesis by eight Plate
Extraperiosteal eight plate insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparative Study Between Growth Guided Correction By ( 8 Plate ) and Corrective Osteoclasis in Management of Coronal Deformity of Lower Limb in Children
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

October 5, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 5, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEPVOMPCKD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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