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:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00648479
First received: March 17, 2008
Last updated: December 25, 2011
Last verified: December 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: New Method for Distal Interlocking of Cannulated Intramedullary Nails

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00648479     History of Changes
Other Study ID Numbers: EKL-001-HMO-CTIL
Study First Received: March 17, 2008
Last Updated: December 25, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Fracture Fixation

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on April 15, 2014