Platelet Rich Plasma (PRP) in Total Knee Replacement

The purpose of this clinical study is to evaluate the effect of platelet rich plasma (PRP), a derivative of a patient's whole blood, on short-term patient outcomes following total knee replacement (TKR). The hypothesis is that change in short-term hemoglobin (Hgb) levels is less dramatic in patients who undergo TKR with the addition of PRP when compared to patients who undergo TKR without PRP.

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 PRP in Total Knee.
• 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) week post-operative period although longer follow-up is 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
• 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 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 an investigational medical device, drug, or biologic clinical trial (active defined as having treatment within the last 30 days)