Platelet Rich Plasma (PRP) in Total Knee Replacement

NCT00826098 | Completed Phase 4

• 1 other identifier: CR07-004
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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).

Conditions

Osteoarthritis; Inflammatory Arthritis

Keywords

Total knee replacement; Platelet Rich Plasma; PRP; Biologic; Randomized

Outcome Measures

Primary Outcomes (1)

• Hemoglobin level

  Hemoglobin level analysis

  Change in hemoglobin (Hgb) level (preop compared to postop day 2)

Study Arms (2)

1 (PRP)

EXPERIMENTAL

Total knee replacement with PRP

Biological: Platelet Rich Plasma

2 (non-PRP)

NO INTERVENTION

Total knee replacement without PRP

Interventions

Platelet Rich Plasma BIOLOGICAL

Addition of PRP to total knee replacement procedure

Also known as: Accelerate PRP

1 (PRP)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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) week post-operative period although longer follow-up is desired
• Patient agrees to participate by signing an IRB approved Informed Consent Form

You may not qualify if:

• 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
• 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 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 an investigational medical device, drug, or biologic clinical trial (active defined as having treatment within the last 30 days)

Sponsors & Collaborators

• Exactech: lead

Study Sites (2)

Center for Joint Replacement, St. Mary's Regional Medical Center

Lewiston, Maine, 04240, United States

Location

Peninsula Orthopedic Associates

Salisbury, Maryland, 21804, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Wayne Moody, MD

  Central Maine Orthopaedics, PA

  PRINCIPAL INVESTIGATOR

• Pasquale Petrera, MD

  Peninsula Orthopedic Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2009
• First Posted: January 21, 2009
• Study Start: December 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: February 1, 2013
• Last Updated: September 1, 2022

Record last verified: 2022-08

Locations

US (2)