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.)
Sponsor:
Information provided by (Responsible Party):
Exactech
ClinicalTrials.gov Identifier:
NCT01075230
First received: February 23, 2010
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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
Osteoarthritis
Procedure: Total knee arthroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual analogue scale (VAS) for pain [ Time Frame: Preop, post-op day 1, post-op day 2, discharge, 6 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

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

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
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: NCT01075230

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

No publications provided

Responsible Party: Exactech
ClinicalTrials.gov Identifier: NCT01075230     History of Changes
Other Study ID Numbers: CR08-004
Study First Received: February 23, 2010
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 29, 2014