Platelet Rich Plasma (PRP) in Total Knee Replacement

Study Overview
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Brief Summary
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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
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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.

Official Title
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Platelet Rich Plasma (PRP) in Total Knee Replacement: A Prospective, Randomized, Single-blind, Single-center Clinical Study to Evaluate the Effect of Platelet Rich Plasma (PRP) on Short-term Patient Outcomes Following Total Knee Replacement

Conditions
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Osteoarthritis, Inflammatory Arthritis

Intervention / Treatment
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* Biological: Platelet Rich Plasma


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 (PRP)<br>Total knee replacement with PRP | Biological: Platelet Rich Plasma<br>* Addition of PRP to total knee replacement procedure<br>* Other names: Accelerate PRP;|
| No Intervention: 2 (non-PRP)<br>Total knee replacement without PRP | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin level | Hemoglobin level analysis | Change in hemoglobin (Hgb) level (preop compared to postop day 2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total knee replacement, Platelet Rich Plasma, PRP, Biologic, Randomized