1 Department of Orthopaedic Surgery, Tianjin First Center Hospital, Tianjin, China.
2 Department of Orthopaedic Surgery, Yonsei University College of Medicine, Seoul, South Korea.
Foot Ankle Int. 2018 Feb;39(2):155-165. doi: 10.1177/1071100717737988. Epub 2017 Nov 7.
The mobile-bearing Salto total ankle prosthesis has been reported to have promising outcomes. However, clinical reports on this prosthesis are few, and most have been published by the inventors and disclosed consultants.
We retrospectively reviewed 59 patients who received Salto prosthesis unilaterally. The average follow-up was 35.9 (range, 6-56) months. Clinical and radiologic results were evaluated. Clinical results were evaluated according to visual analog scale (VAS), American Orthopaedic Foot & Ankle Society (AOFAS) ankle-hindfoot score, Ankle Osteoarthritis Scale (AOS) pain and disability score, and ankle range of motion (ROM) in dorsiflexion/plantarflexion. In the radiographic evaluation, we measured the tibial angle (TA), talar angle (TAL), tibial slope, and talocalcaneal angle (TCA) on weightbearing radiographs.
By the last follow-up, 7 of 59 patients (11.9%) had undergone reoperation, and 3 of 59 implants (5.1%) had been removed. The prosthesis survival was 94.9% (95% CI, 89.1%-100%). With any reoperation as the endpoint of follow-up, the clinical success rate was 88.1% (95% CI, 79.4%-96.9%). The mean postoperative visual analog scale score, AOFAS ankle-hindfoot score, and Ankle Osteoarthritis Scale pain and disability score improved significantly ( P < .001). The ankle range of motion also improved from preoperative 33.4 ± 16.6 to 40.3 ± 15.5 postoperatively ( P < .001); however, there was no statistically significant change in plantarflexion ( P = .243). Radiolucent areas and osteolysis were found in 28 (47.5%) and 27 (45.8%) patients, respectively. Heterotopic ossification was observed in 13 patients (22.0%).
In this series, early clinical and radiographic outcomes of this prosthesis were promising. We believe the early radiolucent lines were probably due to the gap at the implant and bone interface, and they disappeared at the time of osseous integration. However, longer follow-up is necessary to determine the long-term durability and survivorship of this implant, particularly given the high incidence of postoperative osteolysis.
Level IV, case series.
带移动平台的 Salto 全踝关节假体的临床效果已有报道,令人期待。然而,目前有关该假体的临床报告较少,且大多数为发明者和披露顾问发表。
我们回顾性分析了 59 例接受单侧 Salto 假体的患者。平均随访 35.9(6-56)个月。评估临床和影像学结果。临床结果根据视觉模拟评分(VAS)、美国矫形足踝协会(AOFAS)踝关节-后足评分、踝关节骨关节炎量表(AOS)疼痛和残疾评分以及背屈/跖屈踝关节活动范围进行评估。在影像学评估中,我们测量负重位 X 线片上的胫骨角(TA)、距骨角(TAL)、胫骨倾斜角和距跟角(TCA)。
末次随访时,59 例患者中有 7 例(11.9%)接受了再次手术,59 例假体中有 3 例(5.1%)被取出。假体生存率为 94.9%(95%CI,89.1%-100%)。以任何再次手术为随访终点,临床成功率为 88.1%(95%CI,79.4%-96.9%)。术后 VAS 评分、AOFAS 踝关节-后足评分和 AOS 疼痛和残疾评分均显著改善(P<0.001)。踝关节活动度也从术前的 33.4±16.6°改善至术后的 40.3±15.5°(P<0.001);但跖屈无统计学意义的变化(P=0.243)。28 例(47.5%)患者和 27 例(45.8%)患者分别发现透亮区和骨溶解。13 例(22.0%)患者出现异位骨化。
在本系列中,该假体的早期临床和影像学结果令人鼓舞。我们认为早期的透亮线可能是由于假体和骨界面之间的间隙,在骨整合时它们消失了。然而,需要更长时间的随访来确定该假体的长期耐用性和存活率,特别是考虑到术后骨溶解的发生率较高。
IV 级,病例系列研究。