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NCT00648479 Clinical Trial

New Method for Distal Interlocking of Cannulated Intramedullary Nails

Fracture Clinical Trial

Official title:
New Method for Distal Interlocking of Cannulated Intramedullary Nails

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00648479
Other study ID # EKL-001-HMO-CTIL
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received March 17, 2008
Last updated December 25, 2011

Study information
Verified date December 2011
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 10
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

1. Signing Informed consent.

2. Conscious patients.

Exclusion Criteria:

1. Hemodynamic Instability.

2. Multiple system injuries.

3. Pregnancy.

4. Soldiers.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• The Guiding Star

• fluoroscopy (OEC 9800 - General Electric)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Outcome
Type Measure Description Time frame Safety issue
Primary the outcome will be asses using regular fluoroscopy in the operation room.
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