Platelet Rich Plasma (PRP) in Total Knee Replacement

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00826098
• Other study ID #: CR07-004
• Status: Completed
• Phase: Phase 4
• Start date: December 2008
• Est. completion date: February 2013

Study information

• Verified date: August 2022
• Source: Exactech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 2013
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Inflammatory Arthritis
• Osteoarthritis

Intervention

Biological:
• Platelet Rich Plasma
Addition of PRP to total knee replacement procedure

Locations

Country	Name	City	State
United States	Center for Joint Replacement, St. Mary's Regional Medical Center	Lewiston	Maine
United States	Peninsula Orthopedic Associates	Salisbury	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Exactech

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin level	Hemoglobin level analysis	Change in hemoglobin (Hgb) level (preop compared to postop day 2)