Randomized, Prospective Comparison of Two Femoral Reaming Systems

NCT00594438 | Completed

• 1 other identifier: F061204007
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Synthes Reamer-Irrigator-Aspirator (RIA); Zimmer Sentinal Reamer; Transesophageal Echocardiogram (TEE)

Outcome Measures

Primary Outcomes (1)

• Determine which of 2 femoral reamers is best for patients.

  Surgery: 2-3 hours; Follow-up: 3-6 months

Study Arms (2)

1, A

EXPERIMENTAL

Femoral reaming with the Synthes Reamer-Irrigator-Aspirator (RIA)

Device: Synthes Reamer-Irrigator-Aspirator (RIA)

2 B

ACTIVE COMPARATOR

Femoral reaming with a Zimmer Sentinel Reamer.

Device: Zimmer Sentinel Reamer

Interventions

Synthes Reamer-Irrigator-Aspirator (RIA) DEVICE

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.

Also known as: Reamer-Irrigator-Aspirator, Synthes

1, A

Zimmer Sentinel Reamer DEVICE

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.

2 B

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• injuries include isolated or multiple trauma which includes a femur fracture requiring operative fixation using an intramedullary nail using antegrade approach
• Adult patients ages 19-50 years old

You may not qualify if:

• pathologic fractures
• femoral deformities which would preclude intramedullary nailing
• pregnancy
• previous ipsilateral femoral nailing
• pediatric femoral fractures (\<19 years old)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Synthes Inc.: collaborator

Study Sites (1)

The University of Alabama at Birmingham, Orthopaedic Trauma

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• David A Volgas, MD

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 15, 2008
• Study Start: January 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: November 26, 2013

Record last verified: 2013-11

Locations

US (1)