Frigg Arno, Germann Ursula, Huber Martin, Horisberger Monika
Orthopedic Department, University of Basel, Spitalstrasse 21, 4031, Basel, Switzerland.
Foot and Ankle Surgery Zürich, Bahnhofstrasse 56, 8001, Zürich, Switzerland.
Int Orthop. 2017 Oct;41(10):2075-2082. doi: 10.1007/s00264-017-3583-2. Epub 2017 Jul 26.
The purpose of this study was to evaluate survival and clinical outcome of the Scandinavian total ankle replacement (STAR) prosthesis after a minimum of ten years up to a maximum of 19 years.
Fifty STAR prostheses in 46 patients with end stage ankle osteoarthritis operated between 1996 and 2006 by the same surgeon (MH) were included. Minimal follow-up was ten years (median 14.6 years, 95% confidence interval [CI] 12.9-16.4). Clinical (Kofoed score) and radiological assessments were taken before the operation and at one, ten (+2), and 16 (±3) years after implantation. The primary endpoint was defined as exchange of the whole prosthesis or conversion to arthrodesis (def. 1), exchange of at least one metallic component (def. 2), or exchange of any component including the inlay (due to breakage or wear) (def. 3). Survival was estimated according to Kaplan-Meier. Further reoperations related to STAR were also recorded.
The ten year survival rate was (def. 1) 94% (CI 82-98%), (def. 2) 90% (CI, 77-96%), and (def. 3) 78% (CI 64-87%). The 19-year survival rate was (def. 1) 91% (CI 78-97%), (def. 2) 75% (CI 53-88%), and (def. 3) 55% (CI 34-71%). Considering any re-operations related to STAR, 52% (26/50) of prostheses were affected by re-operations. Mean pre-operative Kofoed score was 49, which improved to 84 after one year (n = 50), to 90 after ten years (n = 46), and to 89 after 16 years (n = 28).
The survival rate for def. 1 and 2 was high. However, re-operations occurred in 52% of all STAR prosthesis.
Retrospective cohort study, evidence Level 4.
本研究旨在评估斯堪的纳维亚全踝关节置换（STAR）假体在至少10年至最长19年的随访期后的生存率及临床疗效。
纳入1996年至2006年间由同一位外科医生（MH）为46例终末期踝关节骨关节炎患者植入的50个STAR假体。最短随访期为10年（中位随访期14.6年，95%置信区间[CI] 12.9 - 16.4）。在手术前以及植入后1年、10年（±2年）和16年（±3年）进行临床（Kofoed评分）和影像学评估。主要终点定义为整个假体置换或转为关节融合术（定义1）、至少一个金属部件置换（定义2）或包括镶嵌物（因破损或磨损）在内的任何部件置换（定义3）。根据Kaplan - Meier法估计生存率。还记录了与STAR相关的进一步再手术情况。
10年生存率（定义1）为94%（CI 82 - 98%），（定义2）为90%（CI 77 - 96%），（定义3）为78%（CI 64 - 87%）。19年生存率（定义1）为91%（CI 78 - 97%），（定义2）为75%（CI 53 - 88%），（定义3）为55%（CI 34 - 71%）。考虑到与STAR相关的任何再手术，52%（26/50）的假体受到再手术影响。术前Kofoed评分均值为49，术后1年提高到84（n = 50），10年后提高到90（n = 46），16年后提高到89（n = 28）。
定义1和2的生存率较高。然而，所有STAR假体中有52%发生了再手术。
回顾性队列研究，证据级别4。
