How Does a Novel In Situ Fixed-bearing Implant Design Perform in Revision Ankle Arthroplasty in the Short Term? A...

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.

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.