Standard Total Knee Arthroplasty Using Platelet Rich Plasma (PRP)

Not Applicable

Terminated

• Conditions: Osteoarthritis
• Interventions: Procedure: Total knee arthroplasty

• 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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-23
• Study First Submitted QC: 2010-02-24
• Study First Posted: 2010-02-25
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-09-01

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

Arm && Interventions

Group	Intervention	Description
Standard TKA	Total knee arthroplasty	Subjects in this arm will receive total knee replacement as standard of care without Platte Rich Plasma
Standard TKA with PRP	Total knee arthroplasty	Subjects in this arm will receive total knee replacement as standard of care with Platte Rich Plasma

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