Platelet Rich Plasma (PRP) in Total Knee Replacement

Sponsor

Exactech (Industry)

Overall Status

Completed

CT.gov ID

NCT00826098

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Osteoarthritis Inflammatory Arthritis	Biological: Platelet Rich Plasma	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

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

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 (PRP) Total knee replacement with PRP	Biological: Platelet Rich Plasma Addition of PRP to total knee replacement procedure Other Names: Accelerate PRP
No Intervention: 2 (non-PRP) Total knee replacement without PRP

Arm

Intervention/Treatment

Experimental: 1 (PRP)

Total knee replacement with PRP

Biological: Platelet Rich Plasma

Addition of PRP to total knee replacement procedure

Other Names:

Accelerate PRP

No Intervention: 2 (non-PRP)

Total knee replacement without PRP

Outcome Measures

Primary Outcome Measures

Hemoglobin level [Change in hemoglobin (Hgb) level (preop compared to postop day 2)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Joint Replacement, St. Mary's Regional Medical Center	Lewiston	Maine	United States	04240
2	Peninsula Orthopedic Associates	Salisbury	Maryland	United States	21804