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
  Purpose

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 Intervention Phase
Osteoarthritis
Inflammatory Arthritis
Biological: Platelet Rich Plasma
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Exactech:

Primary Outcome Measures:
  • Hemoglobin level [ Time Frame: Change in hemoglobin (Hgb) level (preop compared to postop day 2) ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: December 2008
Study Completion Date: February 2013
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826098

Locations
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
Exactech
Investigators
Principal Investigator: Wayne Moody, MD Central Maine Orthopaedics, PA
Principal Investigator: Pasquale Petrera, MD Peninsula Orthopedic Associates
  More Information

No publications provided

Responsible Party: Exactech
ClinicalTrials.gov Identifier: NCT00826098     History of Changes
Other Study ID Numbers: CR07-004, V. March 26, 2008 (1 site), V. January 8, 2009 (1 site)
Study First Received: January 20, 2009
Last Updated: July 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Exactech:
Total knee replacement
Platelet Rich Plasma
PRP
Biologic
Randomized

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014