Standard Total Knee Arthroplasty Using Platelet Rich Plasma (PRP)
Not Applicable
Terminated
- Conditions
- Osteoarthritis
- Registration Number
- NCT01075230
- Lead Sponsor
- Exactech
- Brief Summary
Clinical study to determine if there is a difference in hemoglobin level between patients undergoing total knee arthroplasty with and without platelet-rich plasma.
- Detailed 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 50
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in hemoglobin (Hgb) level Preop, post-op day 2 Hemoglobin level analysis
- Secondary Outcome Measures
Name Time Method Visual analog scale (VAS) for pain Preop, post-op day 1, post-op day 2, discharge, 6 weeks Visual analog scale for Pain (1-10), 10 being the worst
Trial Locations
- Locations (1)
Henrico Doctors' Hospital
🇺🇸Richmond, Virginia, United States
Henrico Doctors' Hospital🇺🇸Richmond, Virginia, United States