Sponsored by Zimmer Biomet, the PROGRESS IV clinical trial is investigating a device called the nSTRIDE® APS Kit for people who have knee osteoarthritis (OA).
The goal of this trial is to evaluate the safety and clinical effectiveness of autologous protein solution (APS), prepared from a small sample of a patient’s own blood with the investigational nSTRIDE APS Kit, on pain and function associated with knee OA.
What is Osteoarthritis?
Osteoarthritis (OA), the most common type of arthritis, is a progressive disease of the joints. Often referred to as “wear and tear” arthritis, OA occurs when the top layer of cartilage, the slippery tissue that covers the ends of bones in a joint and helps absorb the shock of movement, breaks down and wears away. The bones under the cartilage then rub together, causing pain, swelling and loss of motion in that joint. Eventually, the joint may lose its normal shape and/or develop bone spurs around its edges.
Some of the criteria you must meet to be in the trial are listed below. If you do not meet all of these you will not be eligible. If you meet all of these, your doctor will then determine if you meet the remaining criteria and can be enrolled in the trial. Additional exclusion criteria may be found here.
You must meet the minimum requirements:
*Have symptomatic osteoarthritis in only one knee
*Be between 21 and 80 years old
*Be willing and able to comply with the trial procedures and visit schedules
*Have a body mass index less than or equal to 40 kg/m2
*Have undergone at least one conservative osteoarthritis treatment without satisfactory pain relief
*Not have had recent intra-articular steroid injections (3 months) or hyaluronic acid (HA) or other joint injections (6 months) in the arthritic knee
Is there a cost to participate in this trial?
You will not incur any extra costs for the medical care and examinations that are not considered standard of care. You may incur costs associated with travel to your doctor’s
office. Extra visits to your doctor’s office are required for follow up care throughout the trial. You will receive payment for participation in the trial. You can ask your health care provider for details.
For a list of frequently asked questions, please visit: http://www.zimmerbiomet.com/nSTRIDEtrial/patients/faqs.html.
Dr. Fred Azar (Coordinating Investigator) and Dr. Santos Martinez (Lead Investigator) are the physicians leading this trial at Campbell Clinic.
To see if you qualify for the PROGRESS IV clinical trial, text 1KNEE to the number 87888, call (773) 313-3077, or visit zimmerbiomet.com/nstridetrial.