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Amount of Correction of Torsional Deformity in Blount's Disease After Coronal Plane Deformity Correction by 8 Plate Hemiepiphysiodesis

Primary Purpose

Blount Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
8 plate hemiepiphysiodesis
Sponsored by
Assiut University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blount Disease

Eligibility Criteria

18 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Skeletally immature patients over 2.5 years of age and less than 12 years of age who presented with pathologic tibia vara.( Langenskiöld type 1,2and 3) associated with intoeing.

Exclusion Criteria:

  1. Skeletal maturity.
  2. Epiphyseal dysplasia.
  3. Metabolic and neurologic disorders.
  4. previous trauma.
  5. Patients younger than 2.5 years and older than 12 years old

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The amount of correction of torsional deformity in patients with Blount's disease after coronal plane deformity correction by 8 plate hemiepiphysiodesis.
    Measuring in postoperative long film x-rays and CT axial profile.

    Secondary Outcome Measures

    Site of torsional correction (foot-tibia-femur) in each part.
    Measuring in postoperative long film x-rays and CT axial profile.
    Any complications detected
    Follow up of the patient postoperatively and clinical examination.

    Full Information

    First Posted
    March 28, 2022
    Last Updated
    April 18, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05334862
    Brief Title
    Amount of Correction of Torsional Deformity in Blount's Disease After Coronal Plane Deformity Correction by 8 Plate Hemiepiphysiodesis
    Official Title
    Amount of Correction of Torsional Deformity in Blount's Disease After Coronal Plane Deformity Correction by 8 Plate Hemiepiphysiodesis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2022 (Anticipated)
    Primary Completion Date
    April 2024 (Anticipated)
    Study Completion Date
    May 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study is to evaluate the amount of correction of torsional deformity in Blount's disease after coronal plane deformity correction by 8 plate hemiepiphysiodesis.
    Detailed Description
    Blount disease, also known as pathologic tibia vara , is an acquired growth disorder of the medial proximal tibial physis and epiphysis that results in a three-dimentional deformity of the lower limb (a progressive varus ,procurvatum and internal rotaion deformity of the tibia). Blount disease can be classified as infantile, or early onset form, which appears before the age of four years, juvenile, which appears between four and ten years and adolescent, or late onset form, which appears in children older than ten years. Surgical treatment options include tibial osteotomies with either acute or gradual correction and proximal lateral tibial hemiepiphysiodesis (guided growth) the latter being less invasive and with significantly lower rate of major complications. Guided growth by 8 plate hemiepiphysiodesis is commonly used to correct coronal plane deformity around the knee. Since its introduction by Stevens in 2007 many studies have demonstrated the efficacy, safety and advantages of tension band plating in the paediatric age group as an alternative to corrective osteotomy. The marked intoeing seen in Blount disease may be caused by internal tibial torsion, femoral anteversion or metatarsus adductus ..yet, there is no enough available literature studies evaluating the amount of correction of tortional deformity after coronal plane deformity correction by 8 plate hemiepiphysiodesis. This is the question of this study and we are trying to answer it by measuring the torsional plane deformity after achieving full correction of coronal plane deformity by 8 plate hemiepiphysiodesis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Blount Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Skeletally immature patients over 2.5 years of age and less than 12 years of age who presented with pathologic tibia vara.( Langenskiöld type 1,2and 3) associated with intoeing.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    8 plate hemiepiphysiodesis
    Intervention Description
    surgical procedure by lateral incision in proximal tibia and fixation by usuing 8 plate and screws.
    Primary Outcome Measure Information:
    Title
    The amount of correction of torsional deformity in patients with Blount's disease after coronal plane deformity correction by 8 plate hemiepiphysiodesis.
    Description
    Measuring in postoperative long film x-rays and CT axial profile.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Site of torsional correction (foot-tibia-femur) in each part.
    Description
    Measuring in postoperative long film x-rays and CT axial profile.
    Time Frame
    1 year
    Title
    Any complications detected
    Description
    Follow up of the patient postoperatively and clinical examination.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Months
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Skeletally immature patients over 2.5 years of age and less than 12 years of age who presented with pathologic tibia vara.( Langenskiöld type 1,2and 3) associated with intoeing. Exclusion Criteria: Skeletal maturity. Epiphyseal dysplasia. Metabolic and neurologic disorders. previous trauma. Patients younger than 2.5 years and older than 12 years old
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andrew Boles, Resident doctor
    Phone
    01225078186
    Email
    andrewandrew44444@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hesham Elbaseet, Doctor
    Phone
    01007780689
    Email
    Drhesham20@aun.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hesham Elbaseet, Doctor
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33463434
    Citation
    Ozdemir E, Emet A, Ramazanov R, Yilmaz G. Correction of coronal plane deformities around knee in children with two-hole tension band plates. Jt Dis Relat Surg. 2021;32(1):177-184. doi: 10.5606/ehc.2021.78879. Epub 2021 Jan 6.
    Results Reference
    background
    PubMed Identifier
    27741108
    Citation
    Heflin JA, Ford S, Stevens P. Guided growth for tibia vara (Blount's disease). Medicine (Baltimore). 2016 Oct;95(41):e4951. doi: 10.1097/MD.0000000000004951.
    Results Reference
    background

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    Amount of Correction of Torsional Deformity in Blount's Disease After Coronal Plane Deformity Correction by 8 Plate Hemiepiphysiodesis

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