New Method for Distal Interlocking of Cannulated Intramedullary Nails

Phase 2TerminatedNCT00648479

Hadassah Medical Organization10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Fracture

Interventions

The Guiding StarDEVICE

fluoroscopy (OEC 9800 - General Electric)DEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Signing Informed consent. 2. Conscious patients. Exclusion Criteria: 1. Hemodynamic Instability. 2. Multiple system injuries. 3. Pregnancy. 4. Soldiers.

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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