Platelet Rich Plasma (PRP) in Total Knee Replacement
Primary Purpose
Osteoarthritis, Inflammatory Arthritis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Platelet Rich Plasma
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Total knee replacement, Platelet Rich Plasma, PRP, Biologic, Randomized
Eligibility 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 PRP in Total Knee.
- 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) week post-operative period although longer follow-up is 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
- 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 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 an investigational medical device, drug, or biologic clinical trial (active defined as having treatment within the last 30 days)
Sites / Locations
- Center for Joint Replacement, St. Mary's Regional Medical Center
- Peninsula Orthopedic Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1 (PRP)
2 (non-PRP)
Arm Description
Total knee replacement with PRP
Total knee replacement without PRP
Outcomes
Primary Outcome Measures
Hemoglobin level
Hemoglobin level analysis
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00826098
Brief Title
Platelet Rich Plasma (PRP) in Total Knee Replacement
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Exactech
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Clinical study 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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Inflammatory Arthritis
Keywords
Total knee replacement, Platelet Rich Plasma, PRP, Biologic, Randomized
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 (PRP)
Arm Type
Experimental
Arm Description
Total knee replacement with PRP
Arm Title
2 (non-PRP)
Arm Type
No Intervention
Arm Description
Total knee replacement without PRP
Intervention Type
Biological
Intervention Name(s)
Platelet Rich Plasma
Other Intervention Name(s)
Accelerate PRP
Intervention Description
Addition of PRP to total knee replacement procedure
Primary Outcome Measure Information:
Title
Hemoglobin level
Description
Hemoglobin level analysis
Time Frame
Change in hemoglobin (Hgb) level (preop compared to postop day 2)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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 PRP in Total Knee.
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) week post-operative period although longer follow-up is 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
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 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 an investigational medical device, drug, or biologic clinical trial (active defined as having treatment within the last 30 days)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne Moody, MD
Organizational Affiliation
Central Maine Orthopaedics, PA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pasquale Petrera, MD
Organizational Affiliation
Peninsula Orthopedic Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Joint Replacement, St. Mary's Regional Medical Center
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
Facility Name
Peninsula Orthopedic Associates
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21804
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Platelet Rich Plasma (PRP) in Total Knee Replacement
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