iRegMed, Tegernsee, Germany.
My Doc Specialist Medical Centre DMCC, Fortune Executive Tower, JLT, Dubai, United Arab Emirates.
Int Orthop. 2021 Feb;45(2):497-507. doi: 10.1007/s00264-020-04870-w. Epub 2021 Jan 6.
To evaluate the safety and efficacy of a novel technique of preconditioning autologous blood with gold particles (GOLDIC®) and injection in patients with moderate to severe knee osteoarthritis (KOA).
During this phase 2a, proof-of-concept (PoC) open label study, 83 consecutive patients that 64 patients met inclusion criteria (mean age: 64.8 years; 89 knees) with radiographically proven KOA, received four ultrasound guided intra-articular knee injections of GOLDIC® at three to six day intervals. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee injury and Osteoarthritis Outcome Score (KOOS) were evaluated at baseline, four weeks, three, six months, one, two and four years (T1-T6). The incidence of treatment related severe adverse events (SAEs) recorded. Intra-articular gelsolin level in patients with effusion was determined.
KOOS and WOMAC scores improved for the full duration of the study (P < 0.05), minimal clinically important difference (MCID) was observed at all time points in all KOOS subscores, with no reported SAEs. Intra-articular gelsolin level increased after treatment with reduction of effusion. No statistically significant evidence of an association between patient demographics and outcome were identified. Nine patients failed treatment, with 32 months mean time to failure and underwent total knee arthroplasty.
PoC study of GOLDIC® as a novel device for conservative management of moderate to severe KOA was confirmed. GOLDIC® produces rapid and sustained improvements in all indices after treatment, with no SAEs.
§ 13 Abs.2b AMG Bavaria (Protokol Reg OBB 5-16) (Ref 53.2-2677.Ph_3-67-2)-Date 3/20/2010 retrospectively registered.
评估用金颗粒（GOLDIC®）预处理自体血液并注射的新方法在中重度膝骨关节炎（KOA）患者中的安全性和有效性。
在这项 2a 期、概念验证（PoC）、开放标签研究中，83 名连续患者中有 64 名符合纳入标准（平均年龄：64.8 岁；89 膝），通过放射学证实患有 KOA，接受了四次超声引导下的关节内膝关节注射 GOLDIC®，间隔 3 至 6 天。在基线、4 周、3、6 个月、1、2 和 4 年（T1-T6）时，使用 Western Ontario 和 McMaster 大学骨关节炎指数（WOMAC）和膝关节损伤和骨关节炎结果评分（KOOS）进行评估。记录治疗相关严重不良事件（SAE）的发生率。在有积液的患者中测定关节内凝胶素水平。
KOOS 和 WOMAC 评分在整个研究期间均有所改善（P<0.05），在所有 KOOS 子评分的所有时间点均观察到最小临床重要差异（MCID），且无报告的 SAE。关节内凝胶素水平在治疗后增加，积液减少。未发现患者人口统计学特征与结果之间存在统计学显著关联的证据。9 名患者治疗失败，平均 32 个月后行全膝关节置换术。
GOLDIC®作为中重度 KOA 保守治疗的新型设备的概念验证研究得到证实。GOLDIC®在治疗后可迅速并持续改善所有指标，且无 SAE。
巴伐利亚 AMG§13 Abs.2b（议定书注册号 OBB 5-16）（Ref 53.2-2677.Ph_3-67-2）-于 2010 年 3 月 20 日回溯性注册。
