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新型固定平台第四代全踝关节置换系统的早期放射学和临床结果。

Early Radiographic and Clinical Outcomes of a Novel, Fixed-Bearing Fourth-Generation Total Ankle Replacement System.

机构信息

Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, NY, USA.

出版信息

Foot Ankle Int. 2022 Nov;43(11):1424-1433. doi: 10.1177/10711007221115185. Epub 2022 Aug 2.

Abstract

BACKGROUND

The Cadence Total Ankle System is a 2-component, fixed-bearing fourth-generation total ankle arthroplasty (TAA) system that was introduced for clinical use in 2016. The purpose of this study was to report non-inventor, non-industry funded survivorship, radiographic and clinical outcomes, and early complications following use of this implant at a minimum of 2 years.

METHODS

This single-center retrospective study included patients who underwent TAA by 2 surgeons with this novel fixed-bearing system between January 2017 and September 2018. Forty-eight patients were evaluated at an average of 33.6 months. Radiographic outcomes included preoperative and postoperative tibiotalar angle on anteroposterior radiographs of the ankle, sagittal tibial angle (STA) on lateral radiographs of the ankle, and periprosthetic lucency formation and location. Revision and reoperation data were collected, and patient-reported outcomes were assessed using Patient Reported Outcomes Measurement Information System (PROMIS). Subgroup analysis assessed associations between preoperative deformity, postoperative implant alignment, PROMIS scores, and periprosthetic lucency formation.

RESULTS

Survivorship of implant was 93.7%, with 3 revisions, 1 due to infection and 2 due to loosening of the implant (1 tibial and 1 talar component). Three patients had reoperations (6.3%): 2 for superficial infection and 1 for gutter debridement due to medial gutter impingement. Fifteen patients (35.8%) developed periprosthetic lucencies, all on the tibial side. PROMIS scores improved after surgery in all domains except Depression. Patients with significant postoperative periprosthetic lucency had worse postoperative PROMIS Physical function scores than patients without lucency ( < .05).

CONCLUSION

This study demonstrated excellent minimum 2-year clinical and radiographic outcomes and low revision and reoperation rates of this new fourth-generation TAA system. Future studies with longer follow-up, especially on patients with periprosthetic lucency, are necessary to investigate the long-term complications and understand the long-term functional and radiographic outcomes of this implant.

摘要

背景

Cadence 全踝关节系统是一种 2 组件、固定轴承的第四代全踝关节置换术(TAA)系统,于 2016 年开始临床应用。本研究的目的是报告非发明者、非行业资助的生存率、影像学和临床结果,以及在至少 2 年的时间内使用该植入物后的早期并发症。

方法

这是一项单中心回顾性研究,纳入了 2017 年 1 月至 2018 年 9 月期间由 2 名外科医生使用该新型固定轴承系统进行 TAA 的患者。48 例患者平均随访 33.6 个月。影像学结果包括踝关节正位片上的术前和术后胫距角、踝关节侧位片上的矢状胫骨角(STA)以及假体周围透光区的形成和位置。收集了翻修和再手术数据,并使用患者报告的结局测量信息系统(PROMIS)评估了患者报告的结局。亚组分析评估了术前畸形、术后植入物对线、PROMIS 评分和假体周围透光区形成之间的关系。

结果

植入物的生存率为 93.7%,3 例患者进行了翻修,其中 1 例因感染,2 例因植入物松动(1 例胫骨和 1 例距骨组件)。3 例患者(6.3%)接受了再手术:2 例为浅表感染,1 例为内侧沟撞击引起的沟道清创术。15 例(35.8%)患者出现假体周围透光区,均位于胫骨侧。除抑郁外,所有患者在所有领域的 PROMIS 评分在手术后均有所改善。术后有明显假体周围透光区的患者的术后 PROMIS 躯体功能评分比无透光区的患者差(<.05)。

结论

本研究表明,这种新型第四代 TAA 系统具有优秀的至少 2 年临床和影像学结果,以及较低的翻修和再手术率。需要进行更长时间随访的未来研究,特别是对假体周围透光区患者的研究,以调查该植入物的长期并发症,并了解该植入物的长期功能和影像学结果。

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