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Proximal Tibial Osteotomy Osteoclasis In Infantile Genu-Varum

Primary Purpose

Deformity Knee, Deformity of Limb

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
osteotomy
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deformity Knee focused on measuring Genu varum, mini-invasive, osteotomy, osteoclasis

Eligibility Criteria

36 Months - 52 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Infantile genu-varum
  • PMTA≤70 not spontaneously corrected

Exclusion criteria:

  • Active rickets or other metabolic disease
  • Patients in whom the femur or the joint is the main site of the deformity

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    high tibial osteotomy

    Arm Description

    Under general anesthesia, a one-cm vertical skin incision was done at the medial subcutaneous border of the tibia, one fingerbreadth below the tibial tuberosity. This was confirmed by intra-operative C-arm images. Longitudinal periosteal incision was done with minimal dissection. Incomplete medial transverse osteotomy including both anterior and posterior cortex was performed using drill bit or small thin osteotome.Osteotomy was completed manually by osteoclasis of the lateral cortex to provide postoperative stability by the preserved lateral periosteum. No fibular osteotomy was needed in the present study.

    Outcomes

    Primary Outcome Measures

    proximal medial tibial angle
    This angle was used for assessment of degree of deformity correction and to follow the presence of under- or over-correction
    the posterior proximal tibial angle
    confirm the absence or presence of any sagittal pro or recurvatum deformities(normal=81±2 degrees)
    Self-Administered Patient Satisfaction Scale
    the investigators asked the parents to rate their satisfaction on a scale from zero to 100 (100 to 75 very satisfied, <75 to 50 somewhat satisfied, <50 to 25 somewhat dissatisfied and <25 dissatisfied).Those who were not satisfied are requested to explain the cause of dissatisfaction.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 9, 2021
    Last Updated
    February 10, 2021
    Sponsor
    Tanta University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04752995
    Brief Title
    Proximal Tibial Osteotomy Osteoclasis In Infantile Genu-Varum
    Official Title
    Proximal Tibial Osteotomy Osteoclasis In Infantile Genu-Varum: Improving the Technique and Managing Potential Complications.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (Actual)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    Genu-varum is a common problem encountered in pediatric orthopedic. Correction of pathological deformity is mandatory to ensure normal load transfer through the knee. In this study, the investigators describe a new technique of osteotomy osteoclasis in order to evaluate if it is an effective and reliable method in management of infantile genu varum
    Detailed Description
    Seventy children with 122 legs suffering significant infantile genu-varum were treated by percutaneous osteotomy-osteoclasis technique. The mean age was 46 months. Genu varum was bilateral in 52 children and unilateral in 18 with a mean preoperative proximal medial tibial angle 66.67 ± 2.670. Under general anesthesia, transverse osteotomy osteoclasis was performed below the tibial tuberosity. Follow-up radiograph was done within the first post-operative week and then every two weeks to assess alignment and consolidation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Deformity Knee, Deformity of Limb
    Keywords
    Genu varum, mini-invasive, osteotomy, osteoclasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    prospective randomized study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    high tibial osteotomy
    Arm Type
    Other
    Arm Description
    Under general anesthesia, a one-cm vertical skin incision was done at the medial subcutaneous border of the tibia, one fingerbreadth below the tibial tuberosity. This was confirmed by intra-operative C-arm images. Longitudinal periosteal incision was done with minimal dissection. Incomplete medial transverse osteotomy including both anterior and posterior cortex was performed using drill bit or small thin osteotome.Osteotomy was completed manually by osteoclasis of the lateral cortex to provide postoperative stability by the preserved lateral periosteum. No fibular osteotomy was needed in the present study.
    Intervention Type
    Procedure
    Intervention Name(s)
    osteotomy
    Intervention Description
    osteotomy osteoclasis of upper tibia
    Primary Outcome Measure Information:
    Title
    proximal medial tibial angle
    Description
    This angle was used for assessment of degree of deformity correction and to follow the presence of under- or over-correction
    Time Frame
    one year
    Title
    the posterior proximal tibial angle
    Description
    confirm the absence or presence of any sagittal pro or recurvatum deformities(normal=81±2 degrees)
    Time Frame
    one year
    Title
    Self-Administered Patient Satisfaction Scale
    Description
    the investigators asked the parents to rate their satisfaction on a scale from zero to 100 (100 to 75 very satisfied, <75 to 50 somewhat satisfied, <50 to 25 somewhat dissatisfied and <25 dissatisfied).Those who were not satisfied are requested to explain the cause of dissatisfaction.
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    36 Months
    Maximum Age & Unit of Time
    52 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Infantile genu-varum PMTA≤70 not spontaneously corrected Exclusion criteria: Active rickets or other metabolic disease Patients in whom the femur or the joint is the main site of the deformity

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    the investigators will publish the final results
    Citations:
    PubMed Identifier
    20234769
    Citation
    Rab GT. Oblique tibial osteotomy revisited. J Child Orthop. 2010 Apr;4(2):169-72. doi: 10.1007/s11832-009-0228-z. Epub 2009 Dec 20.
    Results Reference
    background

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    Proximal Tibial Osteotomy Osteoclasis In Infantile Genu-Varum

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