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Allograft Versus Bioactive Glass (BG-S53P4) in Pediatric Benign Bone Lesions: A Randomized Clinical Trial
The Journal of Bone & Joint Surgery ( IF 5.3 ) Pub Date : 2023-01-19 , DOI: 10.2106/jbjs.22.00716
Johanna Syvänen 1 , Willy Serlo 2 , Jenni Jalkanen 3 , Ia Kohonen 4 , Arimatias Raitio 1 , Yrjänä Nietosvaara 3 , Ilkka Helenius 5
Affiliation  

Background: 

Benign bone cysts in children have a high risk of recurrence after bone grafting. The optimal treatment and filling material for these lesions are currently unknown.

Methods: 

We compared cyst recurrence after intralesional curettage and filling with allograft versus bioactive glass (BG-S53P4; Bonalive) in a randomized clinical trial. The volume of recurrent cyst at 2-year follow-up was the primary outcome.

Results: 

Of 64 eligible children, 51 (mean age, 11.1 years) were randomized to undergo filling of the cyst using morselized allograft (26) or bioactive glass (25). Twelve (46%) of the children in the allograft group and 10 (40%) in the bioactive glass group developed a recurrence (odds ratio [OR] for bioactive glass = 0.79, 95% confidence interval [CI] = 0.25 to 2.56, p = 0.77). The size of the recurrent cyst did not differ between the allograft group (mean, 3.3 mL; range, 0 to 13.2 mL) and the bioactive glass group (mean, 2.2 mL; range, 0 to 16.6 mL, p = 0.43). After adjusting for the type of lesion (aneurysmal bone cyst versus other), bioactive glass also did not prevent larger (>1 mL) recurrent cysts (adjusted OR = 0.42, 95% CI = 0.13 to 1.40, p = 0.16). The Musculoskeletal Tumor Society score improved significantly (p ≤ 0.013) from preoperatively to the 2-year follow-up in both groups (to 28.7 for bioactive glass and 29.1 for bone graft). Four (15%) of the children in the allograft group and 6 (24%) in the bioactive glass group required a reoperation during the follow-up (OR for bioactive glass = 1.74, 95% CI = 0.43 to 7.09, p = 0.50).

Conclusions: 

Filling with bioactive glass and with allograft in the treatment of benign bone lesions provided comparable results in terms of recurrence and complications.

Level of Evidence: 

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.



中文翻译:

同种异体移植物与生物活性玻璃 (BG-S53P4) 在小儿良性骨病变中的对比:一项随机临床试验

背景: 

儿童良性骨囊肿在植骨后复发的风险很高。这些病变的最佳治疗方法和填充材料目前尚不清楚。

方法: 

我们在一项随机临床试验中比较了病灶内刮除术和同种异体移植物填充与生物活性玻璃(BG-S53P4;Bonalive)后囊肿复发。2 年随访时复发囊肿的体积是主要结果。

结果: 

在 64 名符合条件的儿童中,51 名(平均年龄 11.1 岁)被随机分配接受使用颗粒化同种异体移植物 (26) 或生物活性玻璃 (25) 进行囊肿填充。同种异体移植组中有 12 名 (46%) 儿童和生物活性玻璃组中有 10 名 (40%) 儿童出现复发(生物活性玻璃的比值比 [OR] = 0.79,95% 置信区间 [CI] = 0.25 至 2.56, p = 0.77)。复发囊肿的大小在同种异体移植组(平均 3.3 mL;范围 0 至 13.2 mL)和生物活性玻璃组(平均 2.2 mL;范围 0 至 16.6 mL,p = 0.43)之间没有差异。调整病变类型(动脉瘤性骨囊肿与其他)后,生物活性玻璃也不能预防较大的 (>1 mL) 复发性囊肿(调整后的 OR = 0.42,95% CI = 0.13 至 1.40,p = 0.16)。肌肉骨骼肿瘤协会评分显着改善 (p ≤ 0. 013)从术前到 2 年随访(生物活性玻璃为 28.7,骨移植为 29.1)。同种异体移植组中的四名 (15%) 儿童和生物活性玻璃组中的 6 名 (24%) 儿童在随访期间需要再次手术(生物活性玻璃的 OR = 1.74,95% CI = 0.43 至 7.09,p = 0.50 ).

结论: 

用生物活性玻璃填充和用同种异体移植物治疗良性骨病变在复发和并发症方面提供了可比的结果。

证据等级: 

治疗一级。有关证据等级的完整描述,请参阅作者须知。

更新日期:2023-01-19
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