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New Method for Distal Interlocking of Cannulated Intramedullary Nails

Primary Purpose

Fracture

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
The Guiding Star
fluoroscopy (OEC 9800 - General Electric)
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Fracture focused on measuring Fracture Fixation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signing Informed consent.
  2. Conscious patients.

Exclusion Criteria:

  1. Hemodynamic Instability.
  2. Multiple system injuries.
  3. Pregnancy.
  4. Soldiers.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Outcomes

    Primary Outcome Measures

    the outcome will be asses using regular fluoroscopy in the operation room.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 17, 2008
    Last Updated
    December 25, 2011
    Sponsor
    Hadassah Medical Organization
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00648479
    Brief Title
    New Method for Distal Interlocking of Cannulated Intramedullary Nails
    Official Title
    New Method for Distal Interlocking of Cannulated Intramedullary Nails
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2011
    Overall Recruitment Status
    Terminated
    Why Stopped
    the company does not want to proceed yet with the study
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Hadassah Medical Organization

    4. Oversight

    5. Study Description

    Brief Summary
    We intend to include10 patients in this study and trial. Prior to treatment they will sign an informed consent form, stating that they are acquainted with the surgical procedure and study, and that they consent to participate in the study. Five patients will undergo regular operation with Universal tibial reamed nail (AO-Synthes) using the fluoroscopy device: OEC 9800 (GENERAL ELECTRIC). five patients will undergo the same operation using the new navigation system:"The Guiding star" method. The allocation will be random.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fracture
    Keywords
    Fracture Fixation

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    The Guiding Star
    Intervention Type
    Device
    Intervention Name(s)
    fluoroscopy (OEC 9800 - General Electric)
    Primary Outcome Measure Information:
    Title
    the outcome will be asses using regular fluoroscopy in the operation room.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signing Informed consent. Conscious patients. Exclusion Criteria: Hemodynamic Instability. Multiple system injuries. Pregnancy. Soldiers.

    12. IPD Sharing Statement

    Learn more about this trial

    New Method for Distal Interlocking of Cannulated Intramedullary Nails

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