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Randomized, Prospective Comparison of Two Femoral Reaming Systems

NCT00594438 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-11-26

No results posted yet for this study

Summary

The purpose of this study is to compare the quantity of fat that is released into the venous system (blood) by reaming the femoral canal during intramedullary nailing of the femur using two different reaming systems.

Conditions

  • Femur Fracture

Interventions

DEVICE

Synthes Reamer-Irrigator-Aspirator (RIA)

A standard lateral approach to the proximal femur will be utilized. The starting point will be identified using a guide pin and fluoroscopy using standard technique. The attending surgeon will perform the case from the opening of the canal with a drill through the completion of reaming. A transesophageal echocardiogram (TEE) will be recorded from the time the initial reamer engages the cortex until it is removed from the bone. A guide wire will be passed across the fracture site and its position confirmed by fluoroscopic imaging. The femoral canal will be reamed using the RIA device.

DEVICE

Zimmer Sentinel Reamer

A standard lateral approach to the proximal femur will be utilized. The starting point will be identified using a guide pin and fluoroscopy using standard technique. The attending surgeon will perform the case from the opening of the canal with a drill through the completion of reaming. A transesophageal echocardiogram TEE will be recorded from the time the initial reamer engages the cortex until it is removed from the bone. A guide wire will be passed across the fracture site and its position confirmed by fluoroscopic imaging. The femoral canal will be reamed using either a conventional reaming technique or the RIA device.

Sponsors & Collaborators

  • Synthes Inc.

    collaborator INDUSTRY

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • David A Volgas, MD · The University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00594438 on ClinicalTrials.gov