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Birmingham, Alabama 35294


Purpose:

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.


Study summary:

Twenty patients who meet criteria for inclusion in this study will be assigned to one of two groups by means of a computer-generated random number. Group A will consist of 10 patients who undergo reaming with the Synthes reamer-irrigator-aspirator (RIA). Group B will consist of 10 patients who undergo conventional reaming with the Zimmer Sentinel reamer. The patient will be transported to the operating room and will undergo general anesthesia. After correct positioning of the patient on the radiolucent table, baseline data will be collected. This data will consist of a transesophageal echocardiogram (TEE) and arterial blood gas. 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. Though the resident may perform the approach, the attending surgeon will perform the case from the opening of the canal with a drill through the completion of reaming. A 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. For conventional reaming, successive reamers will be used beginning with an 8mm end-cutting reamer and increasing by 1.0 mm increments until cortical "chatter" is detected, then reaming will proceed at 0.5 mm increments for two passes. This is the standard practice using current technology. A Synthes titanium nail of the appropriate length which is 1.0 - 1.5mm less than the last reaming will be chosen for implantation. TEE will be monitored during the pass of the first reamer and the last. For reaming with the RIA, a reamer-irrigator-aspirator of the appropriate size based on pre-operative evaluation of the femoral canal size will be used to perform a single pass down the femoral canal. A Synthes titanium femoral nail of the appropriate length will be selected for implantation. TEE will be recorded during the reaming. An arterial blood gas will be sent after positioning of the patient, when the guide wire is passed down the femoral canal and after the proximal locking screws are placed. Proximal and distal locking screws will be placed in standard fashion. Wound closure and post-operative care will be according to standard protocols. The TEE will be evaluated in a blinded manner by two anesthesiology attendings certified to use and evaluate the TEE. A grading system of 1 through 5 will be used, with 1 representing little to no fat emboli and 5 representative of a large number of fat emboli. This data will be forwarded to the principal investigator and used to fill the appropriate data sheet. Outpatient follow-up will be performed in the usual manner, with sutures/staples being removed at approximately 2 weeks, and radiographs being obtained at 6 and 12 weeks as the attending physician deems clinically necessary. Follow-up for both limbs of the study will be the same as patients not in the study who undergo femoral nailing.


Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - pathologic fractures - femoral deformities which would preclude intramedullary nailing - pregnancy - previous ipsilateral femoral nailing - pediatric femoral fractures (<19 years old)


Study is Available At:


Original ID:

F061204007


NCT ID:

NCT00594438


Secondary ID:


Study Acronym:

RIA


Brief Title:

Randomized, Prospective Comparison of Two Femoral Reaming Systems


Official Title:

Randomized, Prospective Comparison of Two Femoral Reaming Systems


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

19 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Alabama at Birmingham


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Actual


Overall Contact Information

Official Name:David A Volgas, MD
Principal Investigator
The University of Alabama at Birmingham

Study Dates

Start Date:January 2007
Completion Date:December 2007
Completion Type:Actual
Primary Completion Date:December 2007
Primary Completion Type:Actual
Verification Date:November 2013
Last Changed Date:November 23, 2013
First Received Date:December 21, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:Determine which of 2 femoral reamers is best for patients.
Time Frame:Surgery: 2-3 hours; Follow-up: 3-6 months
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Synthes Reamer-Irrigator-Aspirator (RIA)
Description: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 posi
Arm Name:1, A
Other Name:Reamer-Irrigator-Aspirator, Synthes
Intervention Type:Device
Name:Zimmer Sentinel Reamer
Description: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 positi
Arm Name:2 B
Other Name:Zimmer Sentinel Reamer

Study Arms

Study Arm Type:Active Comparator
Arm Name:2 B
Description:Femoral reaming with a Zimmer Sentinel Reamer.
Study Arm Type:Experimental
Arm Name:1, A
Description:Femoral reaming with the Synthes Reamer-Irrigator-Aspirator (RIA)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Alabama at Birmingham
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Synthes Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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