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New Method for Distal Interlocking of Cannulated Intramedullary Nails

This study has been terminated.
(the company does not want to proceed yet with the study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00648479
First Posted: April 1, 2008
Last Update Posted: December 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  Purpose

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 Intervention Phase
Fracture Device: The Guiding Star Device: fluoroscopy (OEC 9800 - General Electric) Phase 1 Phase 2

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

Further study details as provided by Hadassah Medical Organization:

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

Estimated Enrollment: 10
Arms Assigned Interventions
Experimental: 1 Device: The Guiding Star
Active Comparator: 2 Device: fluoroscopy (OEC 9800 - General Electric)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00648479     History of Changes
Other Study ID Numbers: EKL-001-HMO-CTIL
First Submitted: March 17, 2008
First Posted: April 1, 2008
Last Update Posted: December 28, 2011
Last Verified: December 2011

Keywords provided by Hadassah Medical Organization:
Fracture Fixation