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Standard Total Knee Arthroplasty Using Platelet Rich Plasma (PRP)

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: NCT01075230
Recruitment Status : Terminated (Intended as multi-center. 1 of 2 sites could not participate. Enrollment discontinued after 50/100. Subjects followed per protocol.)
First Posted : February 25, 2010
Last Update Posted : November 25, 2013
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Procedure: Total knee arthroplasty Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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.
Study Start Date : February 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: Standard TKA Procedure: Total knee arthroplasty
Subject will undergo total knee arthroplasty according to established surgeon / hospital protocol.
Other Name: Optetrak total knee system

Active Comparator: Standard TKA with PRP Procedure: Total knee arthroplasty
Subject will undergo total knee arthroplasty according to established surgeon / hospital protocol.
Other Name: Optetrak total knee system

Primary Outcome Measures :
  1. Change in hemoglobin (Hgb) level [ Time Frame: Preop, post-op day 2 ]

Secondary Outcome Measures :
  1. Visual analogue scale (VAS) for pain [ Time Frame: Preop, post-op day 1, post-op day 2, discharge, 6 weeks ]

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.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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): NCT01075230

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United States, Virginia
Henrico Doctors' Hospital
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
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Responsible Party: Exactech Identifier: NCT01075230    
Other Study ID Numbers: CR08-004
First Posted: February 25, 2010    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Keywords provided by Exactech:
PRP, TKA, pain scale, hemoglobin, hematocrit, narcotics
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases