Inflammatory Arthritis, Osteoarthritis
Conditions
Keywords
Total knee replacement, Platelet Rich Plasma, PRP, Biologic, Randomized
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 (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.
Interventions
BIOLOGICALPlatelet Rich Plasma
Addition of PRP to total knee replacement procedure
Sponsors
Exactech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Patient agrees to be blinded to their treatment group assignment. 3. 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 4. Patient agrees to participate by signing an IRB approved Informed Consent Form
Exclusion criteria
1. 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 2. Patient has had previous surgery on the operative knee that will necessitate the removal of existing hardware (e.g. previous osteotomy) 3. 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 4. Patient has hemoglobin \< 12.0 (males), \< 11.0 (females) 5. Patient clinically significant anxiety disorder 6. Patient is on therapeutic anticoagulation medication and has an INR \> 1.3 7. Patient has a severe bleeding disorder 8. 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 9. Patient is pregnant 10. Patient is a prisoner 11. Patient is involved in a personal litigation (e.g. Worker's Compensation) that relates to their knee surgery 12. Patient is actively participating in an investigational medical device, drug, or biologic clinical trial (active defined as having treatment within the last 30 days)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin level | Change in hemoglobin (Hgb) level (preop compared to postop day 2) | Hemoglobin level analysis |
Countries
United States
Outcome results
None listed