New Method for Distal Interlocking of Cannulated Intramedullary Nails

Phase 1

Terminated

• Conditions: Fracture
• Interventions: Device: The Guiding Star; Device: fluoroscopy (OEC 9800 - General Electric)

• Registration Number: NCT00648479
• Lead Sponsor: Hadassah Medical Organization

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-03-17
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-01
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-25
• Last Update Posted: 2011-12-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Signing Informed consent.
2. Conscious patients.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	The Guiding Star	-
2	fluoroscopy (OEC 9800 - General Electric)	-

Primary Outcome Measures

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