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Zimmer Biomet Holdings, Inc. announced in a recent press release the results from the PROGRESS II Trial on the safety and efficacy of autologous protein solution prepared with its nStride APS Kit for treating osteoarthritis (OA) of the knee. The study titled “Clinical Outcomes of Knee Osteoarthritis Treated With an Autologous Protein Solution Injection: A 1-Year Pilot Double-Blinded Randomized Controlled Trial”, which originally appeared in The American Journal of Sports Medicine in October 2017, showed that solutions prepared with the kit offer significant improvement in pain, and has a comparable safety to saline.
In this prospective, randomized, double-blind, saline-controlled pilot study, the researchers used the nStride APS (autologous protein solution) Kit to concentrate anti-inflammatory cytokines and growth factors from a sample of the patient’s blood into the autologous protein solution so it can be delivered back to the patient through an intra-articular injection into the knee joint.
A total of 46 patients with unilateral, mild to moderate symptomatic knee osteoarthritis pain from four trial sites across Europe were enrolled in the trial and randomized to receive either a single injection of APS prepared by the nSTRIDE APS kit (n = 31) or a single injection of saline (n = 15).
Both patient-reported outcomes and adverse events were measured at two weeks, one month, three months, six months and 12 months after the injection. Visual Analog Scale (VAS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Knee Injury and Osteoarthritis Outcome Score (KOOS) were used to measure clinical effectiveness. X-ray and magnetic resonance imaging (MRI) were also taken at baseline and again at three and 12 months after the injection.
According to the press release, patients in the APS group had a 65% change in WOMAC pain score from baseline to 12 months compared to the 41% change seen in the saline group (p = .02). Using the VAS, the APS group had a 49% improvement compared to a 13% improvement in the saline group (p = .06). In addition, no serious adverse events were seen either related to the procedure or to the device.
“Inflammation is a critical factor in the pain and cartilage breakdown associated with knee osteoarthritis, and research has established that APS derived from the patient’s whole blood contains a host of powerful anti-inflammatory and anabolic proteins,” said Elizaveta Kon, M.D., associate professor, Humanitas University, Milan, Italy, and lead investigator of the PROGRESS II trial, in a press release.
Currently the nSTRIDE APS Kit is not commercially available in the United States, but holds the CE Mark in Europe and is approved as the APS Kit in Japan. The PROGRESS IV trial is currently enrolling patients and the PROGRESS V trial is being conducted in Europe.
Zimmer Biomet, headquartered in Warsaw, Indiana, is a global leader in musculoskeletal healthcare.
For Further Information
More on the orthopedic large joints replacement market in the U.S. can be found in a series of reports published by iData entitled the U.S. Market Report Suite for Orthopedic Large Joints Replacement Devices. This report covers the following market segments: hip implants, knee implants, and bone cement.
The iData series on the market for orthopedic large joint replacement devices covers the U.S., India, Japan, China, and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about orthopedics large joint replacement market data or procedure data, register online or email us at [email protected] for an U.S. Market Report Suite for Orthopedic Large Joints Replacement Devices brochure and synopsis.