Department of Orthopaedics, Kantonsspital Baselland, Liestal, Switzerland.
Clin Orthop Relat Res. 2023 Jul 1;481(7):1360-1370. doi: 10.1097/CORR.0000000000002515. Epub 2023 Jan 6.
Given the growing number of primary total ankle replacements (TAR), an increase in the number of patients undergoing subsequent revisions might be expected. Achieving a stable and balanced ankle while preserving the remaining bone stock as much as possible is crucial for success in revision TAR. Most reported techniques rely on bulky implants with extended fixation features. Since 2018, we have used a novel, three-component ankle prosthesis for revision that is converted in situ to a fixed-bearing, two-component ankle prosthesis once the components have found their position according to an individual's anatomy. The results of this novel concept (fixation, revision, pain, or function) have not, to our knowledge, been reported.
QUESTIONS/PURPOSES: What are the short-term results with this new revision TAR design, in terms of (1) repeat revision surgery, (2) patient-reported outcomes on the American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score, (3) pain according to the VAS, and (4) radiographic signs of fixation?
Between February 2018 and February 2020, we performed 230 TAR surgeries (in 206 patients) for any indication in our clinic. The novel semiconstrained, uncemented Hintermann Series H2 © implant was used in 96% (220 of 230) of procedures (201 patients). Fifty-four percent (119 of 220) of these were converted from an existing TAR to H2, which was the focus of the present study. However, only 45% (54 of 119) of these conversions to H2 were eligible for analysis. These patients had a mean age of 63 ± 12 years, and 43% (23 of 54) were women. The median (range) follow-up time was 3.2 years (2.0 to 4.3). The H2 design allows in situ conversion to a fixed-bearing system, with minimal bone resection. It achieves translational and rotational stability while preserving function and supporting the periarticular soft tissues. We defined repeat revision as exchange of one or both metal components, ankle fusion, or amputation and assessed it using a cumulative incidence survivorship estimator. Factors potentially associated with revision were assessed using Cox regression analyses. Clinical and radiologic outcomes were assessed preoperatively and at the most recent follow-up interval. Clinical outcomes included pain on the VAS (average pain during normal daily activity during the past seven days) and AOFAS score. Radiologic outcomes were the tibial articular surface angle, tibiotalar surface angle, talar tilt angle in the coronal plane, and AP offset ratio in the sagittal plane, as well as radiolucent lines and radiographic signs of loosening, defined as change in position greater than 2° of the flat base of the tibia component in relation to the long axis of the tibia, subsidence of the talar component into the talus greater than 5 mm, or change in position greater than 5° relative to a line drawn from the top of the talonavicular joint to the tuberosity of the calcaneus, as seen on plain weightbearing radiographs.
The cumulative incidence of repeat revision after 1 and 2 years was 5.6% (95% CI 0% to 11%) and 7.4% (95% CI 0% to 14%), respectively. With the numbers available, no clinical factors we analyzed were associated with the risk of repeat revision. The median values of all assessed clinical outcomes improved; however, not all patients improved by clinically important margins. The median (range) AOFAS ankle-hindfoot score increased (from 50 [16 to 94] to 78 [19 to 100], difference of medians 28; p < 0.01), and the median pain on the VAS decreased (from 5 [0 to 9] to 2 [0 to 9], difference of medians 3; p < 0.01) from before surgery to follow-up at a minimum of 2 years. Radiographically, lucency was seen in 12% (6 of 49 patients) and loosening was seen in 8% (4 of 49). One of these patients showed symptomatic loosening and was among the four patients overall who underwent revision. We could not assess risk factors for repeat revision because of the low number of events (four).
The investigated new in situ fixed-bearing ankle design achieved overall better short-term results than those reported in previous research. Destabilization of the ankle joint complex, soft tissue insufficiency, and possible changes of the joint configuration need an optimal solution in revision arthroplasty. The studied implant might be the answer to this complex issue and help surgeons in the perioperative decision-making process. However, a relatively high percentage of patients did not achieve a clinically important difference. Observational studies are needed to understand long-term implant behavior and possibly to identify ankles benefiting the most from revision.
Level IV, therapeutic study.
鉴于初次全踝关节置换术(TAR)的数量不断增加,预计随后进行的翻修手术数量将会增加。在尽可能保留剩余骨量的情况下,实现稳定和平衡的踝关节对于翻修 TAR 的成功至关重要。大多数报道的技术都依赖于具有扩展固定特征的大型植入物。自 2018 年以来,我们使用了一种新型的、三组件踝关节假体进行翻修,一旦根据个体解剖结构确定了组件的位置,就可以将其原位转换为固定轴承、两组件踝关节假体。这种新型概念(固定、翻修、疼痛或功能)的结果,据我们所知,尚未有报道。
问题/目的:这种新型翻修 TAR 设计的短期结果如何,具体表现在(1)重复翻修手术,(2)美国矫形足踝协会(AOFAS)踝-后足评分的患者报告结果,(3)疼痛的视觉模拟量表(VAS)评分,以及(4)固定的放射学迹象?
在 2018 年 2 月至 2020 年 2 月期间,我们在诊所对任何适应证进行了 230 例 TAR 手术(涉及 206 例患者)。新型半约束性、非骨水泥 Hintermann Series H2©植入物在 96%(220/230)的手术中使用(201 例患者)。其中 54%(119/220)是从现有的 TAR 转换而来,这是本研究的重点。然而,只有 45%(54/119)的 H2 转换符合分析标准。这些患者的平均年龄为 63±12 岁,43%(23/54)为女性。中位(范围)随访时间为 3.2 年(2.0 至 4.3 年)。H2 设计允许原位转换为固定轴承系统,同时最大限度地减少骨切除。它在保留功能和支撑关节周围软组织的同时,实现了平移和旋转稳定性。我们将重复翻修定义为一个或两个金属部件的更换、踝关节融合或截肢,并使用累积发生率生存估计来评估。使用 Cox 回归分析评估与翻修相关的潜在因素。术前和最近的随访间隔评估临床和放射学结果。临床结果包括疼痛的 VAS(过去七天正常日常活动期间的平均疼痛)和 AOFAS 评分。放射学结果包括胫骨关节面角度、距骨关节面角度、冠状面距骨倾斜角以及矢状面 AP 偏移比,以及透亮线和松动的放射学迹象,定义为胫骨组件相对于胫骨长轴的平基位置改变超过 2°,距骨组件沉陷大于 5 毫米,或相对于从舟状骨关节顶部到跟骨结节的线,在平片负重位上观察到的位置改变超过 5°。
术后 1 年和 2 年的重复翻修累积发生率分别为 5.6%(95%CI 0%至 11%)和 7.4%(95%CI 0%至 14%)。根据现有的数据,我们分析的临床因素均与重复翻修的风险无关。所有评估的临床结果的中位数均有所改善;然而,并非所有患者都达到了有临床意义的改善幅度。AOFAS 踝-后足评分的中位数(范围)从 50(16 至 94)增加到 78(19 至 100),中位数差异为 28;p<0.01),VAS 疼痛中位数(范围)从 5(0 至 9)降低到 2(0 至 9),中位数差异为 3;p<0.01),从术前到至少 2 年的随访。放射学上,12%(49 例患者中的 6 例)出现透亮线,8%(49 例患者中的 4 例)出现松动。其中一名患者出现症状性松动,是 4 名总体翻修患者之一。由于事件数量较少(4 例),我们无法评估重复翻修的风险因素。
研究中新型原位固定轴承踝关节设计的短期结果总体优于以往研究报告的结果。踝关节复合体的失稳、软组织不足以及可能的关节结构改变需要在翻修关节置换术中得到最佳解决。研究中使用的植入物可能是解决这一复杂问题的答案,并有助于外科医生在围手术期做出决策。然而,仍有相当比例的患者没有达到有临床意义的改善。需要进行观察性研究,以了解长期植入物的行为,并可能确定哪些踝关节最受益于翻修。
IV 级,治疗性研究。