title: Safety and efficacy findings from a non-interventional study of a new hyaluronic acid/sorbitol formulation (GO-ON® matrix) for intra-articular injection to relieve pain and disability in osteoarthritis patients.
abstract: This non-interventional study was intended to examine the efficacy and tolerability of intra-articular injections with the GO-ON® matrix, a new viscosupplement product made of non-animal sodium hyaluronate combined with the oxygen free radical scavenger sorbitol, when used in routine clinical practice. A total of 1 147 patients (43.5% male, 53,5% female, 3% missing) aged on average 63.3 years with osteoarthritis were enrolled in 398 centers and treated with the product. The most commonly treated joint was the knee (92.9%) with a Kellgren-Lawrence classification of Grade I (6.7%), Grade II (31.4%), Grade III (48.0%), and Grade IV (13.9%).Most patients (58-66%, imputing for missing data) received 1 injection, 29-40% received 3 injections. Using a Likert scale to asses pain, the mean change in pain due to osteoarthritis was a reduction of 56.5% from baseline (2.61±0.80) to 6 months (1.07±0.86). At baseline, 56.2% of patients reported severe/very severe pain versus 5.9% after 6 months. Accordingly, 6.8% of patients reported no pain/mild pain at baseline vs. 67.1% after 6 months. At baseline, 28.9% reported no pain/mild pain vs. to 66.4% after 6 months. At baseline, 29.1% of patients reported severe/very severe functional impairment vs. 3.9% 6 months after the first injection. The 3 and 6 month results were comparable.Adverse reactions were rare and confined to musculoskeletal and connective tissue disorders. No infections were reported in any treated joints. The results confirm that the GO-ON matrix® treatment is effective and well tolerated in the treatment of symptoms due to osteoarthritis.
authors.affiliation: m&i-Fachkliniken Hohenurach, Bad Urach, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Heisel
authors.forename: C
authors.initials: C
authors.lastname: Kipshoven
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002626:Chemistry, Pharmaceutical; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D007270:Injections, Intra-Articular; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy*; D013012:Sorbitol / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D013012:Sorbitol; D006820:Hyaluronic Acid