Standard Total Knee Arthroplasty Using Platelet Rich Plasma (PRP)

Exactech

Status

Terminated

Conditions

Osteoarthritis

Treatments

Procedure: Total knee arthroplasty

Study type

Interventional

Funder types

Industry

Identifiers

NCT01075230

CR08-004

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

All

Volunteers

No Healthy Volunteers

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)