Working… Menu

Platelet Rich Plasma (PRP) in Total Knee Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00826098
Recruitment Status : Completed
First Posted : January 21, 2009
Last Update Posted : February 10, 2015
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Inflammatory Arthritis Biological: Platelet Rich Plasma Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: 1 (PRP)
Total knee replacement with PRP
Biological: Platelet Rich Plasma
Addition of PRP to total knee replacement procedure
Other Name: Accelerate PRP

No Intervention: 2 (non-PRP)
Total knee replacement without PRP

Primary Outcome Measures :
  1. Hemoglobin level [ Time Frame: Change in hemoglobin (Hgb) level (preop compared to postop day 2) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00826098

Layout table for location information
United States, Maine
Center for Joint Replacement, St. Mary's Regional Medical Center
Lewiston, Maine, United States, 04240
United States, Maryland
Peninsula Orthopedic Associates
Salisbury, Maryland, United States, 21804
Sponsors and Collaborators
Layout table for investigator information
Principal Investigator: Wayne Moody, MD Central Maine Orthopaedics, PA
Principal Investigator: Pasquale Petrera, MD Peninsula Orthopedic Associates
Layout table for additonal information
Responsible Party: Exactech Identifier: NCT00826098    
Other Study ID Numbers: CR07-004
V. March 26, 2008 (1 site)
V. January 8, 2009 (1 site)
First Posted: January 21, 2009    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015
Keywords provided by Exactech:
Total knee replacement
Platelet Rich Plasma
Additional relevant MeSH terms:
Layout table for MeSH terms
Joint Diseases
Musculoskeletal Diseases