Standard Total Knee Arthroplasty Using Platelet Rich Plasma (PRP)

NCT01075230 | Terminated

• 1 other identifier: CR08-004
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

PRP, TKA, pain scale, hemoglobin, hematocrit, narcotics

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin (Hgb) level

  Hemoglobin level analysis

  Preop, post-op day 2

Secondary Outcomes (1)

• Visual analog scale (VAS) for pain

  Preop, post-op day 1, post-op day 2, discharge, 6 weeks

Study Arms (2)

Standard TKA

ACTIVE COMPARATOR

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

Procedure: Total knee arthroplasty

Standard TKA with PRP

ACTIVE COMPARATOR

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

Procedure: Total knee arthroplasty

Interventions

Total knee arthroplasty PROCEDURE

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

Also known as: Optetrak total knee system

Standard TKA; Standard TKA with 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
• 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

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 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)

Sponsors & Collaborators

• Exactech: lead

Study Sites (1)

Henrico Doctors' Hospital

Richmond, Virginia, 23294, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2010
• First Posted: February 25, 2010
• Study Start: February 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: September 1, 2022

Record last verified: 2022-08

Locations

US (1)