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The Use Of Growing Rods In Pediatric Long Bones Deformity Correction

Primary Purpose

Deformity of Limb

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
operative deformity correction
Sponsored by
Sohag University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deformity of Limb

Eligibility Criteria

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

Inclusion Criteria:

  • cases of osteogenesis imperfecta
  • metabolic bone deformities
  • cases of hemimelia
  • traumatic bone deformities
  • complex or simple deformities

Exclusion Criteria:

  • adult deformities
  • short bone deformities
  • very narrow medulla
  • osteopetrosis

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The Use Of Growing Rods In Pediatric Long Bones Deformity Correction
    - Evaluation of deformity angles correction after use of growing rods in comparison with preoperative angle

    Secondary Outcome Measures

    Full Information

    First Posted
    February 11, 2022
    Last Updated
    February 22, 2022
    Sponsor
    Sohag University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05251961
    Brief Title
    The Use Of Growing Rods In Pediatric Long Bones Deformity Correction
    Official Title
    The Use Of Growing Rods In Pediatric Long Bones Deformity Correction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2022 (Anticipated)
    Primary Completion Date
    April 30, 2024 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sohag 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
    The objective of this study is to evaluate the value of growing rods for the correction of long bone deformities in pediatric cases attending Sohag University Hospital and follow up aiming at determining benefits and obstacles to this technique
    Detailed Description
    The participants will be subjected to surgical correction using growing rods as a novel technique for their long bone deformities. Procedure will be done under anaesethia Osteotomy , fracture reduction , deformity correction will be done , then introduction of the growing rod

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    operative deformity correction
    Intervention Description
    The participants will be subjected to surgical correction using growing rods as a novel technique for their long bone deformities. Procedure will be done under anaesethia Osteotomy , fracture reduction , deformity correction will be done , then introduction of the growing rod
    Primary Outcome Measure Information:
    Title
    The Use Of Growing Rods In Pediatric Long Bones Deformity Correction
    Description
    - Evaluation of deformity angles correction after use of growing rods in comparison with preoperative angle
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: cases of osteogenesis imperfecta metabolic bone deformities cases of hemimelia traumatic bone deformities complex or simple deformities Exclusion Criteria: adult deformities short bone deformities very narrow medulla osteopetrosis
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abdelmageed Aboelabbas
    Phone
    00201002711810
    Email
    abdelmageed.ortho87@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmad Addosooki
    Phone
    00201011110232
    Email
    addosooki@gmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30216208
    Citation
    Sarikaya I, Seker A, Erdal OA, Gunay H, Inan M, Guler B. Using a corkscrew-tipped telescopic nail in the treatment of osteogenesis imperfecta: a biomechanical study and preliminary results of 17 consecutive cases. J Pediatr Orthop B. 2019 Mar;28(2):173-178. doi: 10.1097/BPB.0000000000000537.
    Results Reference
    background
    PubMed Identifier
    30212425
    Citation
    Persiani P, Ranaldi FM, Martini L, Zambrano A, Celli M, D'Eufemia P, Villani C. Treatment of tibial deformities with the Fassier-Duval telescopic nail and minimally invasive percutaneous osteotomies in patients with osteogenesis imperfecta type III. J Pediatr Orthop B. 2019 Mar;28(2):179-185. doi: 10.1097/BPB.0000000000000536.
    Results Reference
    background

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    The Use Of Growing Rods In Pediatric Long Bones Deformity Correction

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