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Aresearch team at the Florida Hospital Orthopedic Institute is looking for people to take part in a trial for an innovative, nonsurgical, investigational treatment for knee pain and function loss caused by osteoarthritis.
The trial will focus on people with osteoarthritis (OA) in one knee, and will study the potential to alleviate their pain, restore their knee function and possibly have the tissue inside the joint repair itself by using an autologous injectable treatment, instead of pharmaceuticals or surgery.
The researchers are exploring new, non-surgical ways to treat OA, the most common type of arthritis, which is a progressive disease of the joints and often referred to as “wear and tear” arthritis. (1,2) The problem affects approximately 26.9 million adults in the United States alone, including more than one-third (33.6%) of people over the age of 65, according to the U.S. Centers for Disease Control and Prevention. (3)
OA occurs when the top layer of cartilage, the slippery tissue that covers the ends of the bones in a joint and helps absorb the shock of movement, breaks down and wears away. As cartilage breaks down, the level of inflammatory cytokines, a small protein molecule in the blood, rises causing increased breakdown of cartilage (4).
With baby boomers getting older, doctors expect the rate of people with advanced arthritis will only increase, and demand for treatments that provide improved mobility and quality of life will grow to match. (5)
To improve joint function, patients today are encouraged to maintain a healthy body weight and often are treated with pain medications, massage, supplements and heat/cold compresses to offer pain relief. Doctors also often treat patients suffering with osteoarthritis by giving them injections of cortisone and/or hyaluronidase solutions, along with other natural biologics.
The Florida-based researchers are working on this study in hopes of offering an alternative treatment that uses an autologous protein solution (APS). The APS contains growth factors and proteins found in the patient’s own blood to reduce inflammation and promote cartilage repair (6). The process involves drawing a small sample of the patient’s blood and putting it into a centrifuge multiple times to concentrate the beneficial components. The concentrate is then injected back into the knee.
To investigate this treatment, the research team is conducting a double-blind study called the PROGRESS IV clinical trial, sponsored by Zimmer Biomet, a global medical device company. The PROGRESS IV clinical trial is testing a device called the nSTRIDE® APS Kit for people who have OA in one knee.
Researchers are evaluating the safety and clinical effectiveness of autologous protein solution (APS). According to in vitro and animal studies, this concentration may decrease inflammation and promote tissue repair within the joint. (7, 8) It is hoped that the treatment can delay cartilage breakdown, reduce OA pain, and improvement joint function.
The use of APS to treat cells involved in the degenerative process of OA is innovative. As a result of that treatment, researchers believe the cell’s function may change, by signaling a decrease in inflammation instead of promoting inflammation. It is a more advanced approach than other treatments, such as stem cells or Platelet-Rich Plasma (PRP), which only concentrates the cells and growth factors, but does not specifically target the inflammation. The APS process parallels another injectable treatment for arthritis and injuries that big name athletes travelled to Germany to receive. This treatment, Orthokine, cultures the blood serum and passes cells over etched glass beads to cause an effect so that white blood cells produce a natural anti-inflammatory solution (9). It is hoped that through this research study, the APS treatment will become available here in the U.S.
The study has inclusion and exclusion criteria that must be met in order to qualify for participation. Conditions, other than OA, that affect the ability to ambulate or other untreated joint injuries may exclude patients from the study. Eligible patients are enrolled and randomly selected with a 50/50 chance to receive the APS treatment or saline.
For anyone who does not meet the criteria for the study, Dr. Cole’s practice will work with them to find alternative treatment options for managing their osteoarthritis. People may or may not benefit from taking part in the trial, but information learned in the study may help patients with osteoarthritis in the future.
Now accepting patients
Florida Hospital Orthopaedic Institute’s Research Team and Dr. J. Dean Cole are honored to have been selected as an investigational site.
For further information regarding the study, or to determine if you meet eligibility criteria, text 1KNEE to the number 87888, call (773) 313-3077, or visit www.zimmerbiomet.com/nstridetrial.
Dr. J. Dean Cole specializes in orthopaedic traumatology and joint replacements at the Florida Hospital Orthopaedic Institute Fracture Care Center. For more information, go to www.FractureCareCenter.com or call 407-895-8890.
1. OrthoInfo. 2007. American Academy of Orthopaedic Surgeons; [accessed 2017 October 24]. http://orthoinfo.aaos.org/topic.cfm?topic=a00227.
2. Osteoarthritis (OA). 2015. Centers for Disease Control and Prevention; [accessed 2017 October 23]. http://www.cdc.gov/arthritis/basics/osteoarthritis.htm.
3. Osteoarthritis (OA). 2015. Centers for Disease Control and Prevention; [accessed 2017 October 23]. http://www.cdc.gov/arthritis/basics/osteoarthritis.htm.
4. Goldring MB, et al. Defining the roles of inflammatory and anabolic cytokines in cartilage metabolism. Ann Rheum Dis. 2008; 67: iii75-iii82.
5. Maradit Kremers H, et al. Prevalence of total hip and knee replacement in the United States. J Bone Joint Surg Am. 2015;97:1386–97.
6. Matuska A, et al. Autologous solution protects bovine cartilage explants from IL-1α- and TNFα-induced cartilage degradation. J Orthop Res. 2013;31(12):
1929-1935.
7. O’Shaughnessey KM, et al. Blood derived anti-inflammatory protein solution blocks the effect of IL-1β on human macrophages in vitro. Inflamm. Res. 2011;60: 929.
8. King W, et al. Human blood-based anti-inflammatory solution inhibits
osteoarthritis progression in a meniscal-tear rat study. J Orthop Res. (2017).
DOI 10.1002/jor.23528.
9. Fox BA and MM Stephens. Treatment of knee osteoarthritis with
Orthokine-derived autologous conditioned serum. Expert Rev Clin Immunol.
2010; 6(3): 335-345.
