Standard Total Knee Arthroplasty Using Platelet Rich Plasma (PRP)

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Randomized, Single-blind, Multi-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

Intervention / Treatment
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* Procedure: Total knee arthroplasty


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 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)
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 |
| --- | --- |
| Active Comparator: Standard TKA<br>Subjects in this arm will receive total knee replacement as standard of care without Platte Rich Plasma | Procedure: Total knee arthroplasty<br>* Subject will undergo total knee arthroplasty according to established surgeon / hospital protocol.<br>* Other names: Optetrak total knee system;|
| Active Comparator: Standard TKA with PRP<br>Subjects in this arm will receive total knee replacement as standard of care with Platte Rich Plasma | Procedure: Total knee arthroplasty<br>* Subject will undergo total knee arthroplasty according to established surgeon / hospital protocol.<br>* Other names: Optetrak total knee system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin (Hgb) level | Hemoglobin level analysis | Preop, post-op day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (VAS) for pain | Visual analog scale for Pain (1-10), 10 being the worst | Preop, post-op day 1, post-op day 2, discharge, 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PRP, TKA, pain scale, hemoglobin, hematocrit, narcotics