Background

In Europe, fixed-bearing implants predominate again in total ankle replacement (TAR). The present single-center single-surgeon study assesses the Hintegra® mobile-bearing implant (NEWDEAL).

Methods

Between November 2008 and November 2015, 97 Hintegra® were implanted in 94 patients: mean age, 62.4±10.9 years (26−83); 59% (57/97) male; normal mean body-mass index (BMI), 27.5 ± 4.3 kg/m². Indications mainly comprised posttraumatic (40.2%), instability (29.9%) and primary osteoarthritis (16.5%). 17.5% of patients had prior surgery during the previous 6 months (9 fusions, 8 ligament reconstructions, and 4 osteotomies); in 59.8%, other procedures were associated to TAR. Functional, clinical and radiological follow-up was conducted at 1 year, 2 years and last follow-up (>5 years).

Results

Ninety-four TARs were analyzed at a mean 81 ± 21.6 months (19−124). Revision-free survival was 76% (95% confidence interval (95%CI): 0.66–0.8), and explantation-free survival 92% (95%CI: 0.85–1) with 10 cases of curettage and 5 explantations.

Mean AOFAS score improved from 41.8 ± 12.5 (21−69) to 77.5 ± 16.5 (24−100) up (p < 0.001); 75% of patients had no or only mild pain (p < 0.001). Clinical ranges of motion were 8.0 ± 7.1° dorsiflexion (p < 0.001) and 35.1 ± 9.4° plantar flexion (preoperatively, 34.1 ± 7.9°) (p = 0.71).

Radiologically, tibial components were well-positioned; 87% of talar components were well-centered. Global ankle range of motion was 23.5 ± 10.2° (5−48) (p = 0.17). 54.6% of TARs showed posterior tibial calcification at follow-up. Risk of severe cyst (>1 cm) on CT was 36% (95%CI: 23–47) at a mean 77 ± 21.9 months (18−123).

Conclusion

Hintegra® TAR incurred a low risk of revision, and is a reliable option for ankle osteoarthritis.

Level of evidence

IV

中文翻译：

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97 HINTEGRA 踝关节假体：5 年以上随访的结果和生存率

背景

在欧洲，固定轴承植入物在全踝关节置换术 (TAR) 中再次占据主导地位。目前的单中心单外科医生研究评估了 Hintegra® 移动轴承植入物 (NEWDEAL)。

方法

2008 年 11 月至 2015 年 11 月期间，94 名患者植入了 97 颗 Hintegra®：平均年龄 62.4±10.9 岁 (26-83)；59% (57/97) 男性；正常平均体重指数 (BMI)，27.5 ± 4.3 kg/m ² 。适应症主要包括创伤后（40.2%）、不稳定（29.9%）和原发性骨关节炎（16.5%）。17.5% 的患者在过去 6 个月内接受过手术（9 例融合术、8 例韧带重建术和 4 例截骨术）；在 59.8% 中，其他程序与 TAR 相关。在 1 年、2 年和最后一次随访（>5 年）时进行功能、临床和放射学随访。

结果

在平均 81 ± 21.6 个月 (19-124) 时分析了 94 个 TAR。无翻修生存率为 76%（95% 置信区间 (95%CI)：0.66–0.8），无外植生存率为 92%（95%CI：0.85–1），其中 10 例为刮除术，5 例为外植。

平均 AOFAS 分数从 41.8 ± 12.5 (21-69) 提高到 77.5 ± 16.5 (24-100) 向上 (p < 0.001)；75% 的患者没有或仅有轻微疼痛 (p < 0.001)。临床运动范围为 8.0 ± 7.1° 背屈 (p < 0.001) 和 35.1 ± 9.4° 跖屈（术前，34.1 ± 7.9°） (p = 0.71)。

放射学上，胫骨假体定位良好；87% 的距骨组件居中良好。整体脚踝运动范围为 23.5 ± 10.2° (5−48) (p = 0.17)。54.6% 的 TAR 在随访时显示胫骨后部钙化。在平均 77 ± 21.9 个月 (18-123) 时，CT 显示严重囊肿 (>1 cm) 的风险为 36% (95%CI: 23-47)。

结论

Hintegra® TAR 发生翻修的风险很低，是治疗踝骨关节炎的可靠选择。

证据等级

四、