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Multicenter Study
. 2023 Dec;44(12):1239-1246.
doi: 10.1177/10711007231203678. Epub 2023 Oct 30.

Prospective Multicenter Study of Salto Talaris Ankle Arthroplasty With Minimum 4-Year Follow-Up

Chelsea S Mathews  1 , James Davitt  2 , J Chris Coetzee  3 , Jane Shofer  4 , Daniel C Norvell  4   5 , William R Ledoux  4   6   7 , Bruce J Sangeorzan  4   6
Affiliations
Multicenter Study

Prospective Multicenter Study of Salto Talaris Ankle Arthroplasty With Minimum 4-Year Follow-Up

Chelsea S Mathews et al. Foot Ankle Int. 2023 Dec.

Abstract

Background: Total ankle arthroplasty (TAA) continues to be investigated as a primary treatment for end-stage ankle arthritis. The objective of this study is to report mid- to long-term results of the Salto Talaris TAA using prospectively collected patient-reported outcomes and implant survival rates with 4- to 13-year follow-up.

Methods: This was a retrospective study of prospectively collected data from 2 multicenter cohort studies from 3 centers. Three hundred fourteen subjects who received a Salto Talaris TAA from 2005 to 2015 were included in the study. Follow-up ranged 4-13 years following index procedure. Outcomes included 36-Item Short Form Health Survey (SF-36) mental and physical component summary scores, pain scores, and adverse events including additional surgeries, revision, or removal of components.

Results: Significant improvements were seen in pain and physical function scores at 2-year follow-up and were generally maintained through most recent follow-up. The survival rate of the prosthesis was >95% (n = 30/32 at >10 years, n = 272/282 at 4.5-10 years). Thirteen patients (4.1%) underwent revision or removal of their prosthesis. Time to revision ranged from 2 months to 6.5 years following the index procedure. Twenty-two patients (7.0%) had additional surgery that did not involve revision or removal of components.

Conclusion: Treatment of end-stage ankle arthritis with this implant provided patients with improved pain and functional outcome scores at mid- to long-term follow-up. The significant improvements reported at 2-4 years appeared to endure through the extended follow-up period.

Level of evidence: Level III, retrospective cohort study.

Keywords: Salto Talaris; ankle arthritis; total ankle arthroplasty; total ankle replacement.

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Conflict of interest statement

Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: J. Chris Coetzee, MD, reports royalties or licenses from Arthrex, DePuy Synthes, Smith & Nephew, and Responsive Arthroscopy; consulting fees from Medtronic, and Smith & Nephew; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Smith & Nephew and Arthrex; and stock or stock options from Paragon and Responsive Arthroscopy. ICMJE forms for all authors are available online.

Figures

Figure 1.
Figure 1.
AP(top left), mortise (top right), and lateral (bottom) radiographs 6 years status-post primary total ankle arthroplasty (TAA) with Salto Talaris implant.
Figure 2.
Figure 2.
Present pain by study month. Grey lines: individual patient trajectories; red solid and dashed line: mean and 95% CI. Although pain scores are largely varied, the mean shows improvement in pain in the first post-operative year that remains consistent for greater than five years post-operatively. The low number of patients in follow-up six years after index TAA is demonstrated through fewer individual trajectories. The data after 9 years is too sparse to provide accurate trends.
Figure 3.
Figure 3.
SF-36 PCS score by study year. Grey lines: individual patient trajectories; red solid and dashed line: mean and 95% CI. The mean PCS score is increased at one-year status-post TAA and remains steady through nine years of follow-up. The data after 9 years is too sparce to provide accurate trends. Omnibus test for significant change in SF-36 PCS score: p<.0001.
Figure 4.
Figure 4.
SF-36 MCS score by study year. Grey lines: individual patient trajectories; red solid and dashed line: mean and 95% CI. Mean MCS scores improved an average of 0.7 +/− 0.4 points and maintained this improvement through five years. A slightly larger improvement was seen in patients with greater than five years of follow up (3.1 +/− 1.6 points). The data after 9 years is too sparse to provide accurate trends.
Figure 5.
Figure 5.
Probability (95%CI) of Salto device success by months of follow up.
See this image and copyright information in PMC

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