97例HINTEGRA踝关节假体：5年以上随访结果及生存率

97 HINTEGRA ankle prostheses: Results and survival at more than 5 years' follow-up.

作者信息

Van Haecke Adrien, Semay Bertrand, Fessy Michel-Henri, Romain-Scelle Nicolas, Besse Jean-Luc

机构信息

Centre Hospitalier Universitaire de Lyon, Service de Chirurgie Orthopédique et Traumatologique, Centre Hospitalier Lyon-Sud, FR69495 Pierre-Bénite, Rhône-Alpes, France.

Clinique Mutualiste Chirurgicale, 42000 Saint-Etienne, Rhône-Alpes, France.

出版信息

Foot Ankle Surg. 2022 Dec;28(8):1241-1247. doi: 10.1016/j.fas.2022.05.001. Epub 2022 May 14.

DOI:10.1016/j.fas.2022.05.001

PMID:35637107

Abstract

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/m. 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.

摘要

背景

在欧洲，全踝关节置换术（TAR）中固定承重植入物再次占据主导地位。本单中心单术者研究对Hintegra®活动承重植入物（NEWDEAL）进行评估。

方法

2008年11月至2015年11月期间，94例患者植入了97枚Hintegra®：平均年龄62.4±10.9岁（26 - 83岁）；59%（57/97）为男性；平均体重指数（BMI）正常，为27.5±4.3kg/m²。适应证主要包括创伤后（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个月内曾接受过手术（9例融合术、8例韧带重建术和4例截骨术）；59.8%的患者，其他手术与TAR相关。在1年、2年和末次随访（>5年）时进行功能、临床和影像学随访。

结果

平均81±21.6个月（19 - 124个月）时对94例TAR进行了分析。无翻修生存率为76%（95%置信区间（95%CI）：0.66 - 0.8），无取出生存率为92%（95%CI：0.85 - 1），其中10例进行了刮除术，5例进行了取出术。美国足踝外科协会（AOFAS）平均评分从41.8±12.5（21 - 69）提高到77.5±16.5（24 - 100）（p<0.001）；75%的患者无疼痛或仅有轻微疼痛（p<0.001）。临床活动范围为背屈8.0±7.1°（p<0.001），跖屈35.1±9.4°（术前为34.1±7.9°）（p = 0.71）。影像学检查显示，胫骨部件位置良好；87%的距骨部件中心位置良好。全踝关节活动范围为23.5±10.2°（5 - 48°）（p = 0.17）。54.6%的TAR在随访时显示胫骨后钙化。平均77±21.9个月（18 - 123个月）时，CT显示严重囊肿（>1cm）的风险为36%（95%CI：23 - 47）。