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106例Infinity全踝关节置换术的中期生存率:来自英国2家非设计中心的病例系列研究

Midterm Survivorship of 106 Infinity Total Ankle Replacements: A Case Series From 2 Non-designer UK Centers.

作者信息

Dahill Mark, Kostusiak Milos, Dean Michael, Hughes Adrian, Kakwani Rajesh, Murty An, Townshend David, Sharpe Ian

机构信息

Avon Orthopaedic Centre, NHS North Bristol NHS Trust, Bristol, United Kingdom.

Northumbria Healthcare NHS Foundation Trust, North Shields, United Kingdom.

出版信息

Foot Ankle Int. 2025 Aug;46(8):855-861. doi: 10.1177/10711007251341313. Epub 2025 Jun 26.

DOI:10.1177/10711007251341313
PMID:40568754
Abstract

BACKGROUND

The Infinity Total Ankle System is the total ankle replacement (TAR) with market leading share in the United Kingdom and has been implanted in patients since 2014. We report the longest prospective series of Infinity TAR, with mean 8-year survivorship data from 2 nondesigner centers in the United Kingdom. This is a dual-center, prospective, observational study. The primary aims were to assess survivorship and complications of the Infinity TAR. The secondary aims were to assess functional and radiologic outcomes.

METHODS

A total of 102 patients, comprising 106 primary TARs, were recruited into the study. Revision TAR and conversion from ankle arthrodesis were excluded from the study. Survivorship, complication, and patient-reported outcome measure score data were collected prospectively, during preoperative and annual, postoperative appointments. Plain weightbearing radiographs were assessed by 2 nonmasked authors for Canadian Orthopaedic Foot and Ankle Society (COFAS) grade, coronal and sagittal deformity, and formation of periimplant lucencies.

RESULTS

Mean follow-up time was 98 months (range 83-113). Four patients were lost to follow-up, and 12 patients died. Twelve patients underwent secondary surgeries: 8 revision TAR and 4 nonrevision reoperations. The current survivorship of the remaining 90 patients is 91.1% (95% CI, 83.0%-95.4%). Fifteen patients (14%) had complications of surgery. The most common reason for revision surgery was unexplained pain (5 of 8 patients). Manchester-Oxford Foot Questionnaire scores improved from 60 to 22 ( < .01). EQ-5D-5L scores improved from 0.420 to 0.696 ( < .01). The revision rate for this series is 9% at 8 years with a proven deep infection rate of 1%. Lucencies (35% of patients) were mostly asymptomatic.

CONCLUSION

This prospective series of 106 modern fixed-bearing TAR shows an 8-year survivorship of 91%. The fixed-bearing Infinity TAR appears to be a safe, effective intervention in the treatment of end-stage ankle osteoarthritis and gives significant improvement in disease-specific and general health status outcomes.

摘要

背景

Infinity全踝关节系统是一种全踝关节置换术(TAR),在英国拥有领先的市场份额,自2014年起已应用于患者。我们报告了Infinity TAR最长的前瞻性系列研究,包含来自英国2个非设计中心的平均8年生存率数据。这是一项双中心、前瞻性、观察性研究。主要目的是评估Infinity TAR的生存率和并发症。次要目的是评估功能和影像学结果。

方法

共招募了102例患者,包括106例初次TAR。翻修TAR和踝关节融合术转换病例被排除在研究之外。前瞻性收集生存率、并发症以及患者报告的结局测量评分数据,在术前和术后每年的随访中进行收集。由2名未设盲的作者对负重位X线平片进行评估,以确定加拿大足踝协会(COFAS)分级、冠状面和矢状面畸形以及假体周围透亮区的形成情况。

结果

平均随访时间为98个月(范围83 - 113个月)。4例患者失访,12例患者死亡。12例患者接受了二次手术:8例翻修TAR和4例非翻修再次手术。其余90例患者目前的生存率为91.1%(95%CI,83.0% - 95.4%)。15例患者(14%)出现手术并发症。翻修手术最常见的原因是不明原因疼痛(8例患者中的5例)。曼彻斯特 - 牛津足部问卷评分从60分提高到22分(P <.01)。EQ - 5D - 5L评分从0.420提高到0.696(P <.01)。该系列在8年时的翻修率为9%,经证实的深部感染率为1%。透亮区(35%的患者)大多无症状。

结论

这一包含106例现代固定承重TAR的前瞻性系列研究显示8年生存率为91%。固定承重的Infinity TAR似乎是治疗终末期踝关节骨关节炎的一种安全、有效的干预措施,并且在疾病特异性和总体健康状况结局方面有显著改善。

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