Osteoarthritis
Conditions
Keywords
PRP, TKA, pain scale, hemoglobin, hematocrit, narcotics
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.
Interventions
PROCEDURETotal knee arthroplasty
Subject will undergo total knee arthroplasty according to established surgeon / hospital protocol.
Sponsors
Exactech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hemoglobin (Hgb) level | Preop, post-op day 2 | Hemoglobin level analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed