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STRYDE 钉的单中心经验的早期结果:值得关注吗?

Early results from a single centre's experience with the STRYDE nail : a cause for concern?

机构信息

Limb Reconstruction Unit, Royal National Orthopaedic Hospital, Stanmore, UK.

出版信息

Bone Joint J. 2021 Jun;103-B(6):1168-1172. doi: 10.1302/0301-620X.103B6.BJJ-2020-2165.R1.

DOI:10.1302/0301-620X.103B6.BJJ-2020-2165.R1
PMID:34058877
Abstract

AIMS

The STRYDE nail is an evolution of the PRECICE Intramedullary Limb Lengthening System, with unique features regarding its composition. It is designed for load bearing throughout treatment in order to improve patient experience and outcomes and allow for simultaneous bilateral lower limb lengthening. The literature published to date is limited regarding outcomes and potential problems. We report on our early experience and raise awareness for the potential of adverse effects from this device.

METHODS

This is a retrospective review of prospective data collected on all patients treated in our institution using this implant. We report the demographics, nail accuracy, reliability, consolidation index, and cases where concerning clinical and radiological findings were encountered. There were 14 STRYDE nails implanted in nine patients (three male and six female) between June 2019 and September 2020. Mean age at surgery was 33 years (14 to 65). Five patients underwent bilateral lengthening (two femoral and three tibial) and four patients unilateral femoral lengthening for multiple aetiologies.

RESULTS

At the time of reporting, eight patients (13 implants) had completed lengthening. Osteolysis and periosteal reaction at the junction of the telescopic nail was evident in nine implants. Five patients experienced localized pain and swelling. Macroscopic appearances following retrieval were consistent with corrosion at the telescopic junction. Tissue histology was consistent with effects of focal metallic wear debris.

CONCLUSION

From our early experience with this implant we have found the process of lengthening to be accurate and reliable with good regenerate formation and consolidation. Proposed advantages of early load bearing and the ability for bilateral lengthening are promising. We have, however, encountered concerning clinical and radiological findings in several patients. We have elected to discontinue its use to allow further investigation into the retrieved implants and patient outcomes from users internationally. Cite this article:  2021;103-B(6):1168-1172.

摘要

目的

STRYDE 钉是 PRECICE 髓内肢体延长系统的演进,其组成具有独特的特点。它旨在在整个治疗过程中承载负荷,以改善患者的体验和结果,并允许同时进行双侧下肢延长。迄今为止,关于该器械的结果和潜在问题的文献有限。我们报告了我们的早期经验,并提高了对该设备潜在不良影响的认识。

方法

这是对在我们机构中使用该植入物治疗的所有患者的前瞻性数据进行的回顾性分析。我们报告了人口统计学、钉的准确性、可靠性、巩固指数以及遇到令人关注的临床和影像学发现的病例。在 2019 年 6 月至 2020 年 9 月期间,共有 9 名患者(3 名男性和 6 名女性)植入了 14 根 STRYDE 钉。手术时的平均年龄为 33 岁(14 至 65 岁)。5 名患者接受了双侧延长(2 例股骨和 3 例胫骨),4 名患者因多种病因接受了单侧股骨延长。

结果

在报告时,有 8 名患者(13 个植入物)已完成延长。在伸缩钉的交界处可见骨溶解和骨膜反应。9 个植入物中有 5 名患者出现局部疼痛和肿胀。取出后的宏观外观与伸缩交界处的腐蚀一致。组织学检查与聚焦金属磨屑的影响一致。

结论

从我们对该植入物的早期经验来看,我们发现延长过程准确可靠,再生形成和巩固良好。早期承重和双侧延长的优势很有前景。然而,我们在几名患者中发现了令人关注的临床和影像学发现。我们已决定停止使用该植入物,以便对进一步调查国际用户的取出植入物和患者结果。

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