Galactosaminoglycuronoglycan sulfate (matrix) in therapy of tibiofibular osteoarthritis of the knee.

To evaluate the efficacy and tolerance of galactosaminoglycuronoglycan sulfate (Matrix vials) in the therapy of tibiofibular arthritis of the knee, forty patients suffering from this illness at radiological stages 1 and 2 undergoing concomitant therapy with NSAIDS, were randomized into two groups of twenty. The treatment group received the drug under study and the control group received placebo. Treatment was carried out in double blind. The therapy protocol comprised 25 intramuscular injections (one injection twice a week). This cycle was repeated for 6 months, for a total of 50 injections. The patients were visited on days 0, 90, 180, 240, 330 and 360. At each visit the following symptoms were evaluated: spontaneous pain, pain on loading, on passive movement and on pressure; changes in NSAIDS posology were also recorded; lastly any possible side effects were noted. Analysis of results has shown a statistically significant higher therapeutic effect on treatment with Matrix for all the symptoms taken into consideration. No important side effects were noted, either local or systemic; in two cases only in the group treated with Matrix and in the same number in the control group slight dyspeptic symptoms were found to occur, but without requiring suspension or reduction in posology. Two patients in the Matrix group and one in the control group left the study for non-compliance with the type of administration. The good clinical results obtained, together with the excellent tolerance shown by the drug, suggest that Matrix may be the drug of choice in the "basic" therapy of osteoarthritis, with its efficacy being demonstrated in an increasing number of clinical studies.

RCT Entities:   Population Interventions Outcomes