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
About this trial
This is an interventional diagnostic trial for Fracture focused on measuring Fracture Fixation
Eligibility Criteria
Inclusion Criteria:
- Signing Informed consent.
- Conscious patients.
Exclusion Criteria:
- Hemodynamic Instability.
- Multiple system injuries.
- Pregnancy.
- 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
NCT ID
NCT00648479
First Posted
March 17, 2008
Last Updated
December 25, 2011
Sponsor
Hadassah Medical Organization
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
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Primary Completion Date
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Study Completion Date
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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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