Platelet Rich Plasma (PRP) in Total Knee Replacement

Exactech

Status and phase

Completed

Phase 4

Conditions

Osteoarthritis

Inflammatory Arthritis

Treatments

Biological: Platelet Rich Plasma

Study type

Interventional

Funder types

Industry

Identifiers

NCT00826098

CR07-004

Details and patient eligibility

About

Clinical study 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).

Full description

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.

Enrollment

70 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 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)