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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05334862
Collaborator
(none)
15
Enrollment
24
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: 8 plate hemiepiphysiodesis
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
Amount of Correction of Torsional Deformity in Blount's Disease After Coronal Plane Deformity Correction by 8 Plate Hemiepiphysiodesis
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Outcome Measures

Primary Outcome Measures

  1. The amount of correction of torsional deformity in patients with Blount's disease after coronal plane deformity correction by 8 plate hemiepiphysiodesis. [1 year]

    Measuring in postoperative long film x-rays and CT axial profile.

Secondary Outcome Measures

  1. Site of torsional correction (foot-tibia-femur) in each part. [1 year]

    Measuring in postoperative long film x-rays and CT axial profile.

  2. Any complications detected [1 year]

    Follow up of the patient postoperatively and clinical examination.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Months to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: Hesham Elbaseet, Doctor, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Andrew Nasseh Hafeez Boles, Resident doctor, Orthopaedic surgery department, Principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05334862
Other Study ID Numbers:
  • 8 plate in Blount's disease
First Posted:
Apr 19, 2022
Last Update Posted:
Apr 19, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Bone Diseases, Developmental
Osteochondrosis
Congenital Abnormalities

Study Results

No Results Posted as of Apr 19, 2022