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Intramedullary nailing of forearm shaft fractures by biodegradable compared with titanium nails: Results of a prospective randomized trial in children with at least two years of follow-up
Biomaterials ( IF 14.0 ) Pub Date : 2018-09-11 , DOI: 10.1016/j.biomaterials.2018.09.011
Linda Korhonen , Marja Perhomaa , Antti Kyrö , Tytti Pokka , Willy Serlo , Juhani Merikanto , Juha-Jaakko Sinikumpu

There are disadvantages in Elastic Stable Intramedullary Nailing (ESIN) of forearm-shaft fractures, such as the need of implant removal. Biodegradable Intramedullary Nailing (BIN) is a new technique developed for these fractures. We hypothesized that there is no difference in rotational ROM between the patients treated by BIN vs. ESIN.

A randomized, controlled clinical trial included patients, aged 5–15 years, requiring surgery for forearm-shaft fractures. Biodegradable polylactide-co-glycolide (PLGA) nails (Activa IM-Nail™, Bioretec Ltd., Finland) were used in 19 and titanium nails (TEN®, SynthesDePuy Ltd., USA) in 16 patients. Rotational ROM of forearm after two years was the primary outcome. Elbow and wrist ROM, pain and radiographic bone healing were secondary outcomes.

Forearm rotation was mean 162° and 151° in BIN and ESIN groups, respectively (P = 0.201). No difference between the groups was found in any other ROMs. Three cases in the ESIN vs. none in the BIN group reported pain (P = 0.113). There was no clinically significant residual angulation in radiographs. Two adolescents in the BIN group vs. none in the ESIN (P = 0.245) were excluded because of implant failure; another two with complete bone union suffered from re-injury. Therefore, satisfactory implant stability among older children needs to be studied.



中文翻译:

与钛金属钉相比,可生物降解的前臂髓内钉治疗:一项前瞻性随机试验的结果,至少随访了两年

前臂轴骨折的弹性稳定髓内钉(ESIN)有缺点,例如需要去除种植体。可生物降解髓内钉(BIN)是针对这些骨折而开发的一项新技术。我们假设BINESIN治疗的患者之间的旋转ROM没有差异。

一项随机对照临床试验包括5至15岁的需要前臂干骨折手术的患者。生物可降解的聚乳酸-共-乙交酯(PLGA)的钉子(的Activa IM-钉™,Bioretec有限公司,芬兰)在19个钛钉(TEN使用®,SynthesDePuy有限公司,美国)在16名患者。两年后前臂旋转ROM是主要结局。肘关节和腕部ROM,疼痛和影像学骨愈合是次要结果。

BIN组和ESIN组的前臂旋转平均分别为162°和151°(P = 0.201)。在其他任何ROM中都没有发现组之间的差异。ESIN中有3例患者发生疼痛,而BIN组中无3例患者报告疼痛(P = 0.113)。X光片上没有临床上明显的残余角。BIN组有两个青少年,而ESIN组则没有两个(P = 0.245),原因是植入失败。另外两个骨骼完全愈合的人再次受伤。因此,需要研究较大的儿童中令人满意的植入物稳定性。

更新日期:2018-09-11
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