Standard Total Knee Arthroplasty Using Platelet Rich Plasma (PRP)

• Register: ClinicalTrials.gov
• Last refreshed on: 14 January 2013
• Main ID: NCT01075230
• Date of registration: 23/02/2010
• Primary sponsor: Exactech
• Public title: Standard Total Knee Arthroplasty Using Platelet Rich Plasma (PRP)
• Scientific 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.
• Date of first enrolment: February 2010
• Target sample size: 100
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01075230
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion 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)



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Osteoarthritis

Intervention(s)

Procedure: Total knee arthroplasty

Primary Outcome(s)

Change in hemoglobin (Hgb) level [Time Frame: Preop, post-op day 2]

Secondary Outcome(s)

Visual analogue scale (VAS) for pain [Time Frame: Preop, post-op day 1, post-op day 2, discharge, 6 weeks]

Secondary ID(s)

CR08-004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors