To evaluate the safety and efficacy of Cellular Matrix™, a new medical device designed for one-step preparation of platelet-rich plasma in presence of hyaluronic acid, for the management of tibiofemoral knee osteoarthritis in patients who had failed to respond adequately to previous treatment with hyaluronic acid alone. Methods: Multicentre, open-label, uncontrolled, pilot study in 77 patients with grade II or III knee osteoarthritis and a pain at walking score between 3 and 8 on a Numeric Rating Scale. The treatment consisted of a series of 3 intra-articular injections scheduled at D0, D60 and D180 into the affected knee of a combination of platelet-rich plasma and hyaluronic acid prepared with the device Cellular Matrix. The primary efficacy criterion was the variation of pain at walking, as assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (A1 score) between baseline and D270. Results: Treatment with the combination of platelet-rich plasma and hyaluronic acid prepared with Cellular Matrix significantly reduced pain at walking between baseline and D270. The percentage of responders according to the criteria of the Outcome Measures in Rheumatology Clinical Trial and Osteoarthritis Research Society International was 94.4%. The treatment provided long-lasting benefits for half of the patients and allowed avoiding surgery for almost 80% of them at four years. Conclusion: A 3-injection course of a combination of platelet-rich plasma and hyaluronic acid prepared with Cellular Matrix was well tolerated and effective in the long-term to relieve pain associated with symptomatic knee osteoarthritis.
Background: Osteoarthritis (OA) management needs a combination of nonpharmacological and pharmacological modalities. However, as in many chronic conditions, the main concern with OA therapy is the difficulty in obtaining good medication compliance over a long period. The PREDOA study aimed to investigate the predictive factors of adherence to treatment in patients with OA treated with glucosamine sulfate (GS)–copper sulfate–ginger root (GCu), a symptomatic slow-acting drug for OA. Methods: Ambulatory patients with a clinical diagnosis of OA were included in a prospective (6 months) multicenter open-label observational study. All patients received two capsules of GS-GCu once daily for 6 months. Demographics, disease features (OA location, symptom duration, concomitant therapies, comorbidities), and patient self-assessment of pain (0–10) were obtained at baseline. At month 6, the investigator collected patient self-assessments of treatment observance, reasons for nonadherence, pain scores, patient perceptions of treatment efficacy, changes in analgesic intake, and occurrence of adverse events. Predictors of observance were studied in univariate and multivariate analyses. Results: A total of 2,030 patients were included in the study. At baseline, the average pain score was 6.4±1.7. Observance was good in 80% of patients. It was weaker in active than retired patients ( P =0.005) in patients not taking concomitant treatment ( P =0.008) or who had never been treated for OA ( P =0.001). Observance was correlated with pain decrease ( P <0.0001) and with lack of adverse effects ( P <0.001). Age, sex, pain level at baseline, OA location, and number of painful joints were not related to treatment compliance. Conclusion: Medication compliance with GS-GCu depends both on the safety–efficacy balance and several patient related-factors. To improve adherence, detailed information about therapeutic objectives is necessary in active patients who do not get any other medications and for whom it is their first treatment for OA. Clinical trial identifier: CCTIRS 14-371 B.
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