Status:
COMPLETED
Platelet Rich Plasma (PRP) in Total Knee Replacement
Lead Sponsor:
Exactech
Conditions:
Osteoarthritis
Inflammatory Arthritis
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
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).
Detailed 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 (TK...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00826098
Start Date
December 1 2008
End Date
February 1 2013
Last Update
September 1 2022
Active Locations (2)
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1
Center for Joint Replacement, St. Mary's Regional Medical Center
Lewiston, Maine, United States, 04240
2
Peninsula Orthopedic Associates
Salisbury, Maryland, United States, 21804