A double-blind, multicenter, randomized, controlled trial (RCT) that will evaluate the
efficacy of a single dose of Autologous Protein Solution (APS) in patients with
Osteoarthritis (OA) of the knee.
Device: nSTRIDE APS
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT02905240
Ages eligible for Study
21 Years to 80 Years
Genders eligible for Study
Accepts Healthy Volunteers
Male or female ≥ 21 and ≤ 80 years old at the time of screening
Willingness and ability to comply with the study procedures and visit schedules and ability to follow oral and written instructions
A standing radiograph of the knee showing a Kellgren-Lawrence grade of 2 to 4 and an absence of severe osteoarthritis
Body Mass Index ≤ 40
A qualifying WOMAC LK 3.1 pain subscale total score
Has undergone at least one prior conservative osteoarthritis treatment
Signed an institutional review board approved informed consent
Presence of clinically observed active infection in the index knee
Presence of symptomatic osteoarthritis in the non-study knee
Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or arthritis secondary to other inflammatory diseases; HIV, viral hepatitis; chondrocalcinosis, Paget's disease, or villonodular synovitis
Diagnosed with leukemia, known presence of metastatic malignant cells, or ongoing or planned chemotherapeutic treatment
Untreated symptomatic injury of the index knee
Presence of surgical hardware or other foreign body intended to treat arthritis or cartilage-related pathology in the index knee
Previous cartilage repair procedure on the injured cartilage surface of the index knee
Arthroplasty or open surgery of the index knee within 6 months of screening
Intra-articular steroid injection in the index knee within 3 months of screening
Intra-articular hyaluronic acid injection in the index knee within 6 months of screening
Other intra-articular therapy in the index knee within 6 months prior to screening
Orally administered systemic steroid use within 2 weeks of screening
Planned/anticipated surgery of the index knee during the study period
Skin breakdown at the knee where the injection is planned to take place
Pregnant or nursing mothers or women planning on getting pregnant during the time they will be participating in the study
Participated in any investigational drug or device trial within 30 days prior to screening
Participated in any investigational biologic trial within 60 days prior to screening
All locations for NCT02905240
United States (27)
University of Alabama
Birmingham, Alabama, United States, 35294
AVANT Research Associates, LLC
Guntersville, Alabama, United States, 35976
Tucson Orthopaedic Institute, PC
Tucson, Arizona, United States, 85712
CORE Orthopaedic Medical Center
Encinitas, California, United States, 92024
University of California at Los Angeles
Los Angeles, California, United States, 90095
University of California, San Francisco
San Francisco, California, United States, 94158
Andrews Research and Education Foundation (AREF)
Gulf Breeze, Florida, United States, 32561
Florida Hospital Orthopaedic Institute and Fracture Care Center
Orlando, Florida, United States, 32804
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, United States, 33409
Rockford, Illinois, United States, 61114
Orthopedic & Sports Medicine Center
Elkhart, Indiana, United States, 46514
Greenwood, Indiana, United States, 46143
Kansas University Medical Center Research Institute, Inc.
Kansas City, Kansas, United States, 66160
Brigham and Women's Mass General Health Care Center
Foxboro, Massachusetts, United States, 02035
Northwell Health - Great Neck
Great Neck, New York, United States, 11021
Northwell Health - Lenox Hill
New York, New York, United States, 10065
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45229
Ohio State University
Columbus, Ohio, United States, 43221
Joint Implant Surgeons, Inc
New Albany, Ohio, United States, 43054
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
The Campbell Foundation
Germantown, Tennessee, United States, 38138
Baylor College of Medicine
Houston, Texas, United States, 77030
Texas Center for Joint Replacement
Plano, Texas, United States, 75093
University of Virginia
Charlottesville, Virginia, United States, 22903
Richmond, Virginia, United States, 23294
View full eligibility
Tris trial is registered with FDA with number: NCT02905240. The sponsor of the trial is Zimmer Biomet and it is looking for 332 volunteers for the current phase.
Official trial title: A Multicenter, Double-Blind, Randomized, Saline-Controlled Study of a Single, Intra-articular Injection of Autologous Protein Solution in Patients With Knee Osteoarthritis
1What's a trial
4Get in touch
What's a trial
Not sure you're well informed about clinical trials? Learn more about their benefits, risks and other important details.
Enter your details like condition, age, gender and other preferences and we will show you a list of all relevant clinical trials.
Review the summary of the selected clinical trial and all the locations near you in order to see if it's of interest to you.
Get in touch
You've found an interesting trial? We'll need a bit more information about you so we can connect you to the doctor in charge.
Thank you for applying!
We'll contact you soon with more information.
Consult your doctor?
Some people want to consult their doctor before considering participation in a clinical trial. This is absolutely normal as your doctor should know your medical history and should be able to advise you. If you want you can easily share the information for this trial with your doctor by clicking on the button below.