Randomized, Prospective Comparison of Two Femoral Reaming Systems

NACompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

December 31, 2007

Study Completion Date

December 31, 2007

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.

Trial Locations (1)

35294

The University of Alabama at Birmingham, Orthopaedic Trauma, Birmingham

All Listed Sponsors
collaborator

Synthes Inc.

INDUSTRY

lead

University of Alabama at Birmingham

OTHER

NCT00594438 - Randomized, Prospective Comparison of Two Femoral Reaming Systems | Biotech Hunter | Biotech Hunter