Osteoarthritis, Knee Clinical Trial
Official title:
A SINGLE-BLIND, RANDOMIZED, CONTROLLED STUDY OF A SINGLE, INTRA-ARTICULAR INJECTION OF AUTOLOGOUS MICRO-FRAGMENTED ADIPOSE TISSUE (aMAT) VERSUS (VS) PRP IN PATIENTS WITH OSTEOARTHRITIS (OA) OF THE KNEE
The study proposes to compare performances and safety of intra-articular injections of aMAT with those of a control group (PRP injections) for the treatment of symptomatic OA of the knee. The end-points will be determined evaluating the performances of the treatment group in terms of improvement of the symptomatology, functional recovery and radiological appearance.
The clinical trial is a prospective, randomized, controlled, two-arm, single-blind study,
involving 118 patients affected by symptomatic OA of the knee joint. Eligible subjects will
be randomly allocated to one of the two treatment groups, with a 1:1 randomization ratio.
Respectively, 59 patients treated with a single intra-articular injection of aMAT, and 59
patients treated with a single intra-articular injection of PRP.
The patients enrolled in the study will be treated according to the study protocol and
followed after treatment with periodic visits and diagnostic imaging examinations, as
Magnetic Resonance Imaging at twelve and twenty-four months follow-up and X-Ray, at three,
six, twelve, and twenty-four months of follow-up.
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