Platelet Rich Plasma (PRP) in Total Knee Replacement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Exactech
ClinicalTrials.gov Identifier:
NCT00826098
First received: January 20, 2009
Last updated: July 28, 2014
Last verified: July 2014

January 20, 2009
July 28, 2014
December 2008
June 2011   (final data collection date for primary outcome measure)
Hemoglobin level [ Time Frame: Change in hemoglobin (Hgb) level (preop compared to postop day 2) ] [ Designated as safety issue: No ]
Hemoglobin level [ Time Frame: Preop, postop days 1 through discharge, 6 weeks, 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00826098 on ClinicalTrials.gov Archive Site
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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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Osteoarthritis
  • Inflammatory Arthritis
Biological: Platelet Rich Plasma
Addition of PRP to total knee replacement procedure
Other Name: Accelerate PRP
  • Experimental: 1 (PRP)
    Total knee replacement with PRP
    Intervention: Biological: Platelet Rich Plasma
  • No Intervention: 2 (non-PRP)
    Total knee replacement without PRP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
February 2013
June 2011   (final data collection date for primary outcome measure)

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)
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00826098
CR07-004, V. March 26, 2008 (1 site), V. January 8, 2009 (1 site)
No
Exactech
Exactech
Not Provided
Principal Investigator: Wayne Moody, MD Central Maine Orthopaedics, PA
Principal Investigator: Pasquale Petrera, MD Peninsula Orthopedic Associates
Exactech
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP