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
About this trial
This is an interventional treatment trial for Blount Disease
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
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
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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