Clinical trial NCT00826098: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Inflammatory Arthritis
Keywords: Total knee replacement
Platelet Rich Plasma
PRP
Biologic
Randomized
Lead sponsor: Exactech
Sponsor class: INDUSTRY
First posted: 2009-01-21
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Patient agrees to be blinded to their treatment group assignment.
3. 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
4. Patient agrees to participate by signing an IRB approved Informed Consent Form

Exclusion Criteria:

1. 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
2. Patient has had previous surgery on the operative knee that will necessitate the removal of existing hardware (e.g. previous osteotomy)
3. 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
4. Patient has hemoglobin \< 12.0 (males), \< 11.0 (females)
5. Patient clinically significant anxiety disorder
6. Patient is on therapeutic anticoagulation medication and has an INR \> 1.3
7. Patient has a severe bleeding disorder
8. 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
9. Patient is pregnant
10. Patient is a prisoner
11. Patient is involved in a personal litigation (e.g. Worker's Compensation) that relates to their knee surgery
12. Patient is actively participating in an investigational medical device, drug, or biologic clinical trial (active defined as having treatment within the last 30 days)

Primary outcomes:
measure: Hemoglobin level
timeFrame: Change in hemoglobin (Hgb) level (preop compared to postop day 2)
Secondary outcomes:
Other outcomes:
Locations:
city: Lewiston
country: United States
facility: Center for Joint Replacement, St. Mary's Regional Medical Center
state: Maine
city: Salisbury
country: United States
facility: Peninsula Orthopedic Associates
state: Maryland
Study officials:
affiliation: Central Maine Orthopaedics, PA
name: Wayne Moody, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peninsula Orthopedic Associates
name: Pasquale Petrera, MD
role: PRINCIPAL_INVESTIGATOR
References: