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Abstract Background Single 6 ml Hylan G-F 20 injection, is indicated for knee osteoarthritis patients who have failed to respond to non-pharmacologic therapy and/or simple analgesics. To obtain more thorough understanding of the clinical efficacy and safety, a randomized clinical trial was conducted comparing intra-articular (IA) administration of single 6 ml Hylan G-F 20 injection versus placebo in knee OA patients of Chinese ethnicity. Methods This was a randomized, multi-center, double-blind, placebo-controlled clinical trial conducted in 21 centers across China. Four hundred forty adults with knee OA received a single 6 ml Hylan G-F 20 or placebo injection and were evaluated for clinical efficacy and safety outcomes over 26 weeks. Western Ontario and McMaster Universities OA (WOMAC) A1 index, treatment-emergent adverse events (TEAEs) and standard safety parameters were measured at pre-injection, and at weeks 1, 4, 8, 12, 16, 20 and 26 post-injection. Results Four hundred forty patients (male: 98 [22.3%]; female: 342 [77.7%]) were randomized. The mean age [standard deviation (SD)] was 61.5 (7.9) years. All patients were of East Asian ethnicity. Mean WOMAC A1 score at baseline was 5.3 (1.2) and 5.2 (1.3) in single 6 ml Hylan G-F 20 injection and placebo groups, respectively. Significant reductions of WOMAC A1 score were observed in both treatment groups when compared to baseline at 26 weeks post-injection, with the mean reduction of [standard error (SE)/percentage] -2.146 (0.108)/− 40.5% and − 2.271 (0.110) /− 43.7% in the single 6 ml Hylan G-F 20 injection and the placebo groups, respectively. Additionally, clinically important reductions in pain at 26 weeks was reported in 67.0 and 68.2% in single 6 ml Hylan G-F 20 injection and placebo groups (p = 0.36). Regarding safety, TEAEs were similar between the two treatment groups (hylan G-F 20 single: 61.5%; placebo: 64.5%). Conclusions While the magnitude of the effect of a single 6 ml Hylan G-F 20 injection in this study is consistent with previously published literature with respect to the efficacy and safety of the drug, the current study shows a strong IA placebo effect and did not established superiority of single 6 ml Hylan G-F 20 injection over IA placebo in Chinese knee OA patients. Trial registration Prospectively registered Jun 16, 2017 at www.clinicaltrials.gov ( NCT03190369 ).

Abstract Background Gout is a metabolic disease characterized by recurrent episodes of acute arthritis. Gout has been reported in many locations but is rarely localized in the shoulder joint. We describe a rare case of gouty arthritis involving bilateral shoulder joints and leading to severe destructive changes in the right shoulder glenoid. Case presentation A 62-year-old male was referred for pain and weakness in the right shoulder joint for two years, and the pain had increased in severity over the course of approximately nine months. A clinical examination revealed gout nodules on both feet and elbows. A laboratory examination showed a high erythrocyte sedimentation rate (ESR), high levels of C-reactive protein and hyperuricemia, and an imaging examination showed severe osteolytic destruction of the right shoulder glenoid and posterior humeral head subluxation. In addition, the left humeral head was involved and had a lytic lesion. Because a definite diagnosis could not be made for this patient, a right shoulder biopsy was performed. The pathological examination of the specimen revealed uric acid crystal deposits and granulomatous inflammation surrounding the deposits. After excluding infectious and neoplastic diseases, the patient was finally diagnosed with gouty shoulder arthritis. Conclusions Gout affecting the bilateral shoulder joints is exceedingly uncommon, and to our knowledge, severe erosion of the glenoid has not been previously reported. When severe erosion is present, physicians and orthopedic surgeons should consider gouty shoulder arthritis according to previous medical history and clinical manifestations.