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.
SUMMARY
Four cases of multifocal, non‐staphylococcal osteomyelitis are reported. The organisms recovered were aspergillus and serratia in one patient and Klebsiella in two patients. In the fourth patient no organisms were recovered but the diagnosis of tuberculosis was established on the bases of radiographic, clinical and laboratory data and a therapeutic test.
A non‐staphylococcal aetiology should be suspected in all cases of osteomyelitis with unusual radiographic appearances.
To analyze the potential modulatory effect of Cellular Matrix, a new medical device designed for the one-step preparation of platelet-rich plasma in presence of hyaluronic acid, on the structure of articular cartilage in patients suffering from knee osteoarthritis using high-field Magnetic Resonance Imaging measurements of longitudinal relaxation time after gadolinium injection. Methods: The treatment consisted of a series of 3 intra-articular injections scheduled at D0, D60 and D180 into the affected knee of six patients with Kellgren-Lawrence grades of 1.5 to 3. Magnetic Resonance Imaging acquisitions were performed before the first injection at D0 (baseline), at D180 (just after the third injection) and at D270 (3 months after the third injection). The efficacy criterion was the variation of T1 relaxation time in different selected cartilage regions. Results: Our study reveals a positive" time-dependent" structural effect of the combination of PRP and HA obtained with Cellular Matrix on the proteoglycan content of the knee joint cartilage. At D180, the weight-bearing areas were involved in two patients with Kellgren-Lawrence grades equal to or greater than 2. At D270, 5 patients showed an initial improvement in the weight-bearing area; only one patient with early external femoropatellar osteoarthritis (with a Kellgren-Lawrence grade of 1.5) had no improvement. Conclusion: This pilot study demonstrates for the first time the modulatory effect on the structure of the knee joint cartilage of a combination of platelet-rich plasma and hyaluronic acid prepared with a specially dedicated medical device (Cellular Matrix) during the course treatment. Cellular Matrix could therefore be considered a Disease Modifying Osteoarthritis Device.
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