Background: 

Few studies have investigated long-term clinical outcomes of a mobile-bearing total ankle arthroplasty (TAA) system. This study analyzed long-term outcomes of TAA using the HINTEGRA prosthesis at a single, non-developer center.

Methods: 

Primary TAAs were performed on 213 ankles in 194 patients, and 151 consecutive ankles [71%] in 136 patients with a minimum follow-up of 10 years after the primary TAA were included in this study. Clinical results were assessed using a visual analog scale (VAS) pain score, the American Orthopaedic Foot & Ankle Society (AOFAS) Ankle-Hindfoot Scale score, the Ankle Osteoarthritis Scale (AOS) pain and disability subscores, and ankle range of motion. Prosthesis survivorship, reoperations, and risk factors were also evaluated.

Results: 

The mean follow-up was 135.5 months (range, 120.0 to 204.0 months). All clinical scores and ankle range of motion improved significantly from preoperatively to 2 years, 4 to 6 years, and ≥10 years after TAA (p < 0.001). A total of 43 ankles (28.5%) required revision procedures, with the most common reason being periprosthetic osteolysis (32 ankles [21.2%]). The overall implant survivorship was 93.5% in Kaplan-Meier survival analysis at the mean follow-up of 11.3 years after the TAA.

Conclusions: 

TAA using the HINTEGRA prosthesis with careful follow-up observation and appropriate adjunct procedures for the treatment of end-stage ankle arthritis produced satisfactory clinical results, which were maintained at a follow-up of ≥10 years, and resulted in 93.5% of implant survivorship.

Level of Evidence: 

Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.

中文翻译：

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使用 HINTEGRA 假体进行的 151 例全踝关节置换术的长期临床结果和植入物存活率：至少 10 年的随访

背景： 

很少有研究调查活动轴承全踝关节置换术 (TAA) 系统的长期临床结果。本研究在单个非开发中心使用 HINTEGRA 假体分析了 TAA 的长期结果。

方法： 

本研究纳入了 194 名患者的 213 个脚踝进行初次 TAA，136 名患者的 151 个连续脚踝 [71%] 在初次 TAA 后至少随访 10 年。使用视觉模拟评分 (VAS) 疼痛评分、美国骨科足踝协会 (AOFAS) 踝-后足评分、踝关节骨关节炎评分 (AOS) 疼痛和残疾子评分以及踝关节活动度评估临床结果。还评估了假体存活率、再手术和风险因素。

结果： 

平均随访时间为 135.5 个月（范围为 120.0 至 204.0 个月）。从术前到 2 年、4 到 6 年和 TAA 后 10 年，所有临床评分和踝关节活动度均显着改善（p < 0.001）。共有 43 个脚踝（28.5%）需要翻修手术，最常见的原因是假体周围骨质溶解（32 个脚踝 [21.2%]）。在 TAA 后 11.3 年的平均随访中，Kaplan-Meier 生存分析的总体植入物生存率为 93.5%。

结论： 

使用 HINTEGRA 假体的 TAA 以及仔细的随访观察和适当的辅助程序治疗终末期踝关节炎产生了令人满意的临床结果，在 ≥ 10 年的随访中保持，并导致 93.5% 的植入物存活率.

证据等级： 

预后级别 IV。有关证据级别的完整描述，请参见作者说明。