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Standard Total Knee Arthroplasty Using Platelet Rich Plasma (PRP)

This study has been terminated.
(Intended as multi-center. 1 of 2 sites could not participate. Enrollment discontinued after 50/100. Subjects followed per protocol.)
Information provided by (Responsible Party):
Exactech Identifier:
First received: February 23, 2010
Last updated: November 20, 2013
Last verified: November 2013
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 Intervention
Procedure: Total knee arthroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:

Further study details as provided by Exactech:

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

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

Enrollment: 50
Study Start Date: February 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   Child, Adult, Senior
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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01075230

United States, Virginia
Henrico Doctors' Hospital
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
  More Information

Responsible Party: Exactech Identifier: NCT01075230     History of Changes
Other Study ID Numbers: CR08-004
Study First Received: February 23, 2010
Last Updated: November 20, 2013

Keywords provided by Exactech:
PRP, TKA, pain scale, hemoglobin, hematocrit, narcotics

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on May 25, 2017