BACKGROUND AND PURPOSE As a synthetic bone void filler, bioactive glasses (BGs) may enhance angiogenesis and osteogenesis. In this randomized trial, we compared the clinical efficacy of BG granules and standard bone grafts in patients undergoing surgery for benign bone tumors. PATIENTS AND METHODS 49 recruited patients were randomized to receive BG granules or undergo conventional bone grafting to fill defects following tumor removal. As the standard of care, small-sized defects were filled with autologous graft, and large-sized defects were filled with allogeneic graft. The primary endpoint was treatment success at 1 year, defined by no reoperation, no tumor recurrence, and no device-related adverse events. Secondary endpoints included patient-reported outcomes (Rand-36 and pain scores) and quantitative assessment of blood flow and metabolic activity by means of 18F-fluoride PET/CT imaging. As an off-trial group, 15 children and adolescents (age < 18 years) underwent tumor removal and BG-filling, without randomization. RESULTS At 1-year, 21 of 25 BG-treated patients (risk estimate 0.84, 95% confidence interval [CI] 0.70-0.98) and 20 of 24 patients in the standard of care group (0.83, CI 0.68-0.98) met the criteria for treatment success. The groups had similar Rand-36 scores. In patients with small defects, BG filling was associated with shorter operative time and less postoperative pain at 1 month. In patients with large defects, blood flow was similar, but BG-filled defects showed higher metabolic activity than allograft-filled defects at 1-year. The survey of the postoperative period ≥10 years revealed no BG-related adverse events. INTERPRETATION BG granules had similar overall rates of treatment success compared with autografts and allografts, but large-scale trials are needed for the confirmation of clinical equivalence. The extended metabolic activity confirms the expected cellular responses of osseointegrated BG granules.

中文翻译：

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生物活性玻璃颗粒与标准自体和同种异体骨移植物：一项对 49 名成年骨肿瘤患者进行 10 年随访的随机试验。

背景和目的 作为一种合成的骨空隙填充物，生物活性玻璃 (BG) 可以增强血管生成和成骨作用。在这项随机试验中，我们比较了 BG 颗粒和标准骨移植物在接受良性骨肿瘤手术的患者中的临床疗效。患者和方法 49 名招募的患者被随机分配接受 BG 颗粒或接受常规骨移植以填补肿瘤切除后的缺损。作为护理标准，小尺寸缺损用自体移植物填充，大尺寸缺损用同种异体移植物填充。主要终点是 1 年时的治疗成功，定义为没有再次手术、没有肿瘤复发和没有与设备相关的不良事件。次要终点包括患者报告的结果（Rand-36 和疼痛评分）以及通过 18F-氟化物 PET/CT 成像对血流和代谢活动进行定量评估。作为一个非试验组，15 名儿童和青少年（年龄 < 18 岁）接受了肿瘤切除和 BG 填充，没有随机分组。结果 1 年时，25 名接受 BG 治疗的患者中有 21 名（风险估计值为 0.84，95% 置信区间 [CI] 0.70-0.98），标准治疗组 24 名患者中有 20 名（0.83，CI 0.68-0.98）符合治疗成功的标准。这些组具有相似的 Rand-36 分数。在有小缺损的患者中，BG 填充与更短的手术时间和更少的术后 1 个月疼痛相关。在有大缺陷的患者中，血流是相似的，但是 BG 填充的缺陷在 1 年时表现出比同种异体移植物填充的缺陷更高的代谢活性。术后≥10年的调查未发现与BG相关的不良事件。解释 与自体移植物和同种异体移植物相比，BG 颗粒的总体治疗成功率相似，但需要进行大规模试验来确认临床等效性。扩展的代谢活动证实了骨整合 BG 颗粒的预期细胞反应。