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Standard Total Knee Arthroplasty Using Platelet Rich Plasma (PRP)

Not Applicable
Terminated
Conditions
Osteoarthritis
Registration Number
NCT01075230
Lead Sponsor
Exactech
Brief Summary

Clinical study to determine if there is a difference in hemoglobin level between patients undergoing total knee arthroplasty with and without platelet-rich plasma.

Detailed Description

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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
50
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change in hemoglobin (Hgb) levelPreop, post-op day 2

Hemoglobin level analysis

Secondary Outcome Measures
NameTimeMethod
Visual analog scale (VAS) for painPreop, post-op day 1, post-op day 2, discharge, 6 weeks

Visual analog scale for Pain (1-10), 10 being the worst

Trial Locations

Locations (1)

Henrico Doctors' Hospital

🇺🇸

Richmond, Virginia, United States

Henrico Doctors' Hospital
🇺🇸Richmond, Virginia, United States

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