NCT00648479

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2008

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 1, 2008

Completed
Last Updated

December 28, 2011

Status Verified

December 1, 2011

First QC Date

March 17, 2008

Last Update Submit

December 25, 2011

Conditions

Fracture

Keywords

Fracture Fixation

Outcome Measures

Primary Outcomes (1)

  • the outcome will be asses using regular fluoroscopy in the operation room.

Study Arms (2)

1

EXPERIMENTAL
Device: The Guiding Star

2

ACTIVE COMPARATOR
Device: fluoroscopy (OEC 9800 - General Electric)

Interventions

The Guiding StarDEVICE
1
fluoroscopy (OEC 9800 - General Electric)DEVICE
2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signing Informed consent.
  • Conscious patients.

You may not qualify if:

  • Hemodynamic Instability.
  • Multiple system injuries.
  • Pregnancy.
  • Soldiers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fractures, Bone

Interventions

Fluoroscopy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 17, 2008

First Posted

April 1, 2008

Last Updated

December 28, 2011

Record last verified: 2011-12