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经皮骨整合假肢系统(TOPS)用于股骨截肢者——德国最新假肢设计的六年回顾性分析

[Transcutaneous Osseointegrated Prosthetic Systems (TOPS) for Transfemoral Amputees - A Six-Year Retrospective Analysis of the Latest Prosthetic Design in Germany].

作者信息

Ranker Alexander, Örgel Marcus, Beck James Peter, Krettek Christian, Aschoff Horst Heinrich

机构信息

Klinik für Rehabilitationsmedizin, Medizinische Hochschule Hannover.

Klinik für Unfallchirurgie, Medizinische Hochschule Hannover.

出版信息

Rehabilitation (Stuttg). 2020 Dec;59(6):357-365. doi: 10.1055/a-1223-3205. Epub 2020 Aug 31.

Abstract

PURPOSE

A retrospective analysis of clinical outcomes and complication rates of patients treated with the latest implant design of the so-called Endo-Exo-Femoral Prosthesis (EEFP) was performed. The aim is to gain specific information on long-term complications of this treatment-method.

METHODS

In January 2019, data of all transfemoral amputees who were treated with TOPS at an acute clinic in Schleswig-Holstein from 2010 to 2016 were retrospectively analysed. This was done with special consideration of postoperative complications. For this purpose, all examination findings from routine clinical follow-up examinations were used. The complications were divided into stoma problems, orthopaedic-technical (OT) problems, fractures and explantations. All EEFPs had the same implant design (3rd generation). This implant is currently the only TOPS in Germany that is clinically used. Descriptive statistics as well as ratio information about occurred complications were calculated.

RESULTS

A total of 68 implantations were performed during this period. Average observation time was 6.32 years (±2.16 years). The mean age of the patients was 51.84 years±12.12 years. Cause of amputation was mainly trauma (82,35%). Stoma-associated problems had the highest incidence (7%) among all observed patient-related complications and posed the greatest challenges during the rehabilitation process. Looking only at surgical complications, 81% had no complications at all. In total, 15% had technical problems, 6% had peri-prosthetic fractures, 7% had stoma problems and 3% had to be explanted due to infection.

CONCLUSION

The analysis of collected data shows that TOPS (here the 3rd generation EEFP) can be a successful alternative treatment method to shaft prostheses after transfemoral amputation. The indication should only be given after the failure of a shaft-prosthesis and contraindications must be comprehensively excluded. The greatest challenges in the rehabilitation process are the avoidance of stoma complications, infections and OT-problems. The rehabilitation of amputees treated with TOPS therefore requires an interdisciplinary, specialized rehabilitation team and lifelong rehabilitative care.

摘要

目的

对采用所谓的内外侧股骨假体(EEFP)最新植入设计治疗的患者的临床结果和并发症发生率进行回顾性分析。目的是获取有关这种治疗方法长期并发症的具体信息。

方法

2019年1月,对2010年至2016年在石勒苏益格 - 荷尔斯泰因州一家急性诊所接受TOPS治疗的所有经股截肢患者的数据进行回顾性分析。分析时特别考虑了术后并发症。为此,使用了常规临床随访检查的所有检查结果。并发症分为造口问题、骨科技术(OT)问题、骨折和假体取出。所有EEFP均采用相同的植入设计(第三代)。这种植入物是目前德国临床上唯一使用的TOPS。计算了描述性统计数据以及有关发生并发症的比率信息。

结果

在此期间共进行了68次植入手术。平均观察时间为6.32年(±2.16年)。患者的平均年龄为51.84岁±12.12岁。截肢原因主要是创伤(82.35%)。在所有观察到的与患者相关的并发症中,造口相关问题的发生率最高(7%),并且在康复过程中带来了最大的挑战。仅看手术并发症,81%的患者完全没有并发症。总体而言,15%的患者有技术问题,6%的患者发生假体周围骨折,7%的患者有造口问题,3%的患者因感染而不得不取出假体。

结论

对收集数据的分析表明,TOPS(此处指第三代EEFP)可以成为经股截肢后骨干假体的一种成功替代治疗方法。仅应在骨干假体失败后给予该适应症,并且必须全面排除禁忌症。康复过程中最大的挑战是避免造口并发症、感染和OT问题。因此,接受TOPS治疗的截肢患者的康复需要一个跨学科的专业康复团队和终身康复护理。

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