Standard Total Knee Arthroplasty Using Platelet Rich Plasma (PRP)

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.

Clinical study to determine if there is a difference in hemoglobin level between patients undergoing total knee arthroplasty with and without platelet-rich plasma.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis
• Intervention / Treatment: Procedure: Total knee arthroplasty

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23294
      • Henrico Doctors' Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard TKA; Subjects in this arm will receive total knee replacement as standard of care without Platte Rich Plasma	Procedure: Total knee arthroplasty; Subject will undergo total knee arthroplasty according to established surgeon / hospital protocol.; Other Names: Optetrak total knee system
Active Comparator: Standard TKA with PRP; Subjects in this arm will receive total knee replacement as standard of care with Platte Rich Plasma	Procedure: Total knee arthroplasty; Subject will undergo total knee arthroplasty according to established surgeon / hospital protocol.; Other Names: Optetrak total knee system

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Exactech

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: February 23, 2010
• First Submitted That Met QC Criteria: February 24, 2010
• First Posted (Estimate): February 25, 2010

Study Record Updates

• Last Update Posted (Actual): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: PRP, TKA, pain scale, hemoglobin, hematocrit, narcotics
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: CR08-004