Platelet Rich Plasma (PRP) in Total Knee Replacement

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

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).

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Inflammatory Arthritis
• Intervention / Treatment: Biological: Platelet Rich Plasma

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Maine
    • Lewiston, Maine, United States, 04240
      • Center for Joint Replacement, St. Mary's Regional Medical Center
  • Maryland
    • Salisbury, Maryland, United States, 21804
      • Peninsula Orthopedic Associates

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. 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.
2. Patient agrees to be blinded to their treatment group assignment.
3. 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
4. Patient agrees to participate by signing an IRB approved Informed Consent Form

Exclusion Criteria:

1. 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
2. Patient has had previous surgery on the operative knee that will necessitate the removal of existing hardware (e.g. previous osteotomy)
3. 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
4. Patient has hemoglobin < 12.0 (males), < 11.0 (females)
5. Patient clinically significant anxiety disorder
6. Patient is on therapeutic anticoagulation medication and has an INR > 1.3
7. Patient has a severe bleeding disorder
8. 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
9. Patient is pregnant
10. Patient is a prisoner
11. Patient is involved in a personal litigation (e.g. Worker's Compensation) that relates to their knee surgery
12. Patient is actively participating in an investigational 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
Experimental: 1 (PRP); Total knee replacement with PRP	Biological: Platelet Rich Plasma; Addition of PRP to total knee replacement procedure; Other Names: Accelerate PRP
No Intervention: 2 (non-PRP); Total knee replacement without PRP

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Exactech
• Investigators: Principal Investigator: Wayne Moody, MD, Central Maine Orthopaedics, PA; Principal Investigator: Pasquale Petrera, MD, Peninsula Orthopedic Associates

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: January 20, 2009
• First Submitted That Met QC Criteria: January 20, 2009
• First Posted (Estimate): January 21, 2009

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: Randomized; Total knee replacement; Biologic; Platelet Rich Plasma; PRP
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: CR07-004