Standard Total Knee Arthroplasty Using Platelet Rich Plasma (PRP)

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.

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

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.

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
• Patient is involved in a personal litigation (e.g. Worker's Compensation) that relates to their knee surgery
• Patient is actively participating in another medical device, drug, or biologic clinical trial (active defined as having treatment within the last 30 days)