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Corticalisation After Femoral Nail Dynamization in Hypertrophic Non-unions

Primary Purpose

Pseudoarthrosis of Bone, Implant Breakage

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
exchange nailing with larger, thicker nail crossing corticalization
Sponsored by
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pseudoarthrosis of Bone focused on measuring hypertrophic pseudarthrosis, dynamization, corticalisation

Eligibility Criteria

28 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subtrochanteric fractures
  • Nonunion with Pain

Exclusion Criteria:

  • Infection
  • Pathological Fracture (Tumor)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    hypertrophic non-union developing after femoral transverse diaphyseal fractures

    Arm Description

    Outcomes

    Primary Outcome Measures

    Provide Bone Union
    Achievement of bone union with detecting callus formation on radiography after passing the region of corticalisation with a longer and thicker nail
    Relieving pain in the nonunion area
    Detection of reduction of pain scores in the nonunion area and enabling patients to load on the extremity in the early period postoperatively

    Secondary Outcome Measures

    Full Information

    First Posted
    June 9, 2022
    Last Updated
    June 14, 2022
    Sponsor
    Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05423561
    Brief Title
    Corticalisation After Femoral Nail Dynamization in Hypertrophic Non-unions
    Official Title
    Sclerotic Bone Formation (Corticalisation) on the Intramedullar Nail Tip in Hypertrophic Non-union Developing After Femoral Transverse Diaphyseal Fractures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2010 (Actual)
    Primary Completion Date
    July 31, 2020 (Actual)
    Study Completion Date
    May 5, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In 12 patients with corticalization and hypertrophic pseudarthrosis were present after dynamization, the old nail was removed and nail exchange was performed with a longer and larger diameter nail to pass the region formed in the cortex approximately 2-3cm inferior from the old nail.
    Detailed Description
    Corticalization is cortex-like sclerosis in the distal of the nail and it may indicate the early sign of dynamization treatment failure in hypertrophic nonunion after femoral transverse diaphyseal fractures. When corticalization is seen during follow-up after dynamization is performed because of non-union of a femoral transverse fracture, nail exchange should be performed without further delay. More rigid fixation should be applied with a longer and thicker nail crossing the area of corticalization.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pseudoarthrosis of Bone, Implant Breakage
    Keywords
    hypertrophic pseudarthrosis, dynamization, corticalisation

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    hypertrophic non-union developing after femoral transverse diaphyseal fractures
    Arm Type
    Other
    Intervention Type
    Procedure
    Intervention Name(s)
    exchange nailing with larger, thicker nail crossing corticalization
    Intervention Description
    exchange nailing with larger, thicker nail crossing corticalization
    Primary Outcome Measure Information:
    Title
    Provide Bone Union
    Description
    Achievement of bone union with detecting callus formation on radiography after passing the region of corticalisation with a longer and thicker nail
    Time Frame
    6 months
    Title
    Relieving pain in the nonunion area
    Description
    Detection of reduction of pain scores in the nonunion area and enabling patients to load on the extremity in the early period postoperatively
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    28 Years
    Maximum Age & Unit of Time
    49 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subtrochanteric fractures Nonunion with Pain Exclusion Criteria: Infection Pathological Fracture (Tumor)

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Corticalisation After Femoral Nail Dynamization in Hypertrophic Non-unions

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