A Prospective, Randomized, Single-blind, Multi-center Clinical Study to Evaluate the Effect of Platelet Rich Plasma (PRP) on Short-term Patient Outcomes Following Total Knee Replacement.

Exactech1 site in 1 country50 target enrollmentFebruary 2010

ConditionsOsteoarthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Exactech
Enrollment: 50
Locations: 1
Primary Endpoint: Change in hemoglobin (Hgb) level
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Clinical study to determine if there is a difference in hemoglobin level between patients undergoing total knee arthroplasty with and without platelet-rich plasma.

Detailed Description

The purpose of this study is to determine if there is a difference in hemoglobin level between patients undergoing total knee arthroplasty with and without platelet-rich plasma.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

January 2013

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Exactech

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient is a male or female who is undergoing primary unilateral surgery or the first surgery of a staged bilateral total knee replacement where the second stage will be at least 6 weeks later
•Patient agrees to be blinded to their treatment group assignment
•Patient is willing and able to return for follow-up over at least a six (6) month post-operative period although longer follow-up may be desired
•Patient agrees to participate by signing an IRB approved Informed Consent Form

Exclusion Criteria

•Patient will have a staged bilateral total knee replacement with the second stage to be performed less than 6 weeks after the first stage surgery PRP in
•Patient has had previous surgery on the operative knee that will necessitate the removal of existing hardware (e.g. previous osteotomy)
•Patient has a known adverse reaction or sensitivity to bovine (cow) thrombin (used as part of the platelet rich plasma system) or other bovine-derived products
•Patient has hemoglobin \< 12.0 (males), \< 11.0 (females)
•Patient has a clinically significant anxiety disorder
•Patient is on therapeutic anticoagulation medication and has an INR \> 1.3
•Patient has a severe bleeding disorder
•Patient has a known addiction to drugs or alcohol, including, but not limited to: chronic daily use of narcotic medications for more than 90 days prior to surgery
•Patient is pregnant
•Patient is a prisoner