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New Method for Distal Interlocking of Cannulated Intramedullary Nails

NCT ID: NCT00648479

Last Updated: 2011-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Fracture

Keywords

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Fracture Fixation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type EXPERIMENTAL

The Guiding Star

Intervention Type DEVICE

2

Group Type ACTIVE_COMPARATOR

fluoroscopy (OEC 9800 - General Electric)

Intervention Type DEVICE

Interventions

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The Guiding Star

Intervention Type DEVICE

fluoroscopy (OEC 9800 - General Electric)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Signing Informed consent.
2. Conscious patients.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Other Identifiers

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EKL-001-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id