search
Back to results

Management of Combined Fracture Neck of Femur and Femoral Deformity in Osteogenesis Imperfecta Patient (OI)

Primary Purpose

Osteogenesis Imperfecta

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteogenesis Imperfecta focused on measuring Osteogenesis imperfecta, fracture neck of femur, telescoping nail

Eligibility Criteria

2 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: OI Exclusion Criteria: Not receiving Bisphosphonate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    fixation with Wagner technique and Telescoping nail

    Arm Description

    corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture

    Outcomes

    Primary Outcome Measures

    modified McKay's criteria
    hip function score

    Secondary Outcome Measures

    Full Information

    First Posted
    May 18, 2023
    Last Updated
    May 18, 2023
    Sponsor
    Assiut University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05878548
    Brief Title
    Management of Combined Fracture Neck of Femur and Femoral Deformity in Osteogenesis Imperfecta Patient
    Acronym
    OI
    Official Title
    Management of Combined Fracture Neck of Femur and Femoral Deformity in Osteogenesis Imperfecta Patient
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    April 1, 2024 (Anticipated)
    Study Completion Date
    April 1, 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
    O.I with NOF fixed by Wagner technique and telescoping nail
    Detailed Description
    osteogenesis imperfecta (Sillence Type IV) sustained neck of femur fracture after fall on ground. He had proximal femoral anterolateral bowing on top of inserted rod 4 years ago. He was treated with corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture. One year after operation the patient gained satisfactory functional outcome with union of NOF fracture and correction of femoral deformity. This rare case illustrates the anticipated difficulties in managing neck of femur fracture in osteogenesis imperfect patients. The method of fixation with Wagner technique can achieve stable fixation for solid healing in fragility fractures like this and the least interference with telescoping nail insertion.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteogenesis Imperfecta
    Keywords
    Osteogenesis imperfecta, fracture neck of femur, telescoping nail

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    fixation with Wagner technique
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    1 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    fixation with Wagner technique and Telescoping nail
    Arm Type
    Experimental
    Arm Description
    corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture
    Intervention Type
    Procedure
    Intervention Name(s)
    corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture
    Intervention Description
    corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture
    Primary Outcome Measure Information:
    Title
    modified McKay's criteria
    Description
    hip function score
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: OI Exclusion Criteria: Not receiving Bisphosphonate
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hesaham M Elbaseet, MD
    Phone
    +2001007780689
    Email
    drhesham20@aun.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hesaham M Elbaseet, MD
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33278111
    Citation
    Hidalgo Perea S, Green DW. Osteogenesis imperfecta: treatment and surgical management. Curr Opin Pediatr. 2021 Feb 1;33(1):74-78. doi: 10.1097/MOP.0000000000000968.
    Results Reference
    background
    PubMed Identifier
    37026790
    Citation
    Fralinger DJ, Kraft DB, Rogers KJ, Thacker MM, Kruse RW, Franzone JM. The Fate of the Bent Rod in Children With Osteogenesis Imperfecta. J Pediatr Orthop. 2023 Jul 1;43(6):e465-e470. doi: 10.1097/BPO.0000000000002409. Epub 2023 Apr 6.
    Results Reference
    background

    Learn more about this trial

    Management of Combined Fracture Neck of Femur and Femoral Deformity in Osteogenesis Imperfecta Patient

    We'll reach out to this number within 24 hrs