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New Method for Distal Interlocking of Cannulated Intramedullary Nails

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ClinicalTrials.gov Identifier: NCT00648479
Recruitment Status : Terminated (the company does not want to proceed yet with the study)
First Posted : April 1, 2008
Last Update Posted : December 28, 2011
Sponsor:
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Fracture Device: The Guiding Star Device: fluoroscopy (OEC 9800 - General Electric) Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: New Method for Distal Interlocking of Cannulated Intramedullary Nails

Arm Intervention/treatment
Experimental: 1 Device: The Guiding Star
Active Comparator: 2 Device: fluoroscopy (OEC 9800 - General Electric)



Primary Outcome Measures :
  1. the outcome will be asses using regular fluoroscopy in the operation room.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signing Informed consent.
  2. Conscious patients.

Exclusion Criteria:

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

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00648479     History of Changes
Other Study ID Numbers: EKL-001-HMO-CTIL
First Posted: April 1, 2008    Key Record Dates
Last Update Posted: December 28, 2011
Last Verified: December 2011

Keywords provided by Hadassah Medical Organization:
Fracture Fixation