Standard Total Knee Arthroplasty Using Platelet Rich Plasma (PRP)

Osteoarthritis Clinical Trial

Official title:

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 Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01075230
• Other study ID #: CR08-004
• Status: Terminated
• Phase: N/A
• Start date: February 2010
• Est. completion date: January 2013

Study information

• Verified date: August 2022
• Source: Exactech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• Total knee arthroplasty
Subject will undergo total knee arthroplasty according to established surgeon / hospital protocol.

Locations

Country	Name	City	State
United States	Henrico Doctors' Hospital	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Exactech

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemoglobin (Hgb) level	Hemoglobin level analysis	Preop, post-op day 2
Secondary	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