Department of Orthopaedic Surgery and Traumatology, Turku University Hospital and University of Turku, Turku.
Unit of Biostatistics, Department of Clinical Medicine, University of Turku, Turku.
Acta Orthop. 2022 Jun 1;93:519-527. doi: 10.2340/17453674.2022.2808.
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.
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.
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.
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.
作为一种合成的骨缺损填充材料，生物活性玻璃（BG）可能促进血管生成和成骨。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切除术患者中的临床疗效。
共招募了 49 名患者，他们被随机分为 BG 颗粒组或接受传统的骨移植来填充肿瘤切除后的缺损。作为标准治疗，小面积缺损用自体移植物填充，大面积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，定义为无再次手术、无肿瘤复发和无器械相关不良事件。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性的定量评估。作为一个非试验组，15 名年龄<18 岁的儿童和青少年接受了肿瘤切除和 BG 填充，未进行随机分组。
在 1 年时，25 名接受 BG 治疗的患者中有 21 名（风险估计值 0.84，95%置信区间 [CI] 0.70-0.98）和 24 名标准治疗组患者中有 20 名（0.83，CI 0.68-0.98）符合治疗成功的标准。两组的 Rand-36 评分相似。在小缺损患者中，BG 填充与 1 个月时较短的手术时间和较少的术后疼痛相关。在大缺损患者中，血流相似，但在 1 年时，BG 填充的缺损显示出比同种异体填充的缺损更高的代谢活性。对术后 10 年以上的调查显示，没有与 BG 相关的不良事件。
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。延长的代谢活性证实了骨整合 BG 颗粒预期的细胞反应。
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