Standard Total Knee Arthroplasty Using Platelet Rich Plasma (PRP)

NCT ID: NCT01075230

Last Updated: 2022-09-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2013-01-31

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard TKA

Subjects in this arm will receive total knee replacement as standard of care without Platte Rich Plasma

Group Type: ACTIVE_COMPARATOR

Total knee arthroplasty

Intervention Type: PROCEDURE

Subject will undergo total knee arthroplasty according to established surgeon / hospital protocol.

Standard TKA with PRP

Subjects in this arm will receive total knee replacement as standard of care with Platte Rich Plasma

Group Type: ACTIVE_COMPARATOR

Total knee arthroplasty

Intervention Type: PROCEDURE

Subject will undergo total knee arthroplasty according to established surgeon / hospital protocol.

Interventions

Total knee arthroplasty

Subject will undergo total knee arthroplasty according to established surgeon / hospital protocol.

Intervention Type: PROCEDURE

Other Intervention Names

Optetrak total knee system

Eligibility 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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Exactech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Henrico Doctors' Hospital

Richmond, Virginia, United States

Countries

United States

Other Identifiers

CR08-004

Identifier Type: -

Identifier Source: org_study_id