Initial Safety of Total Talus Replacement Used to Treat Talar Avascular Necrosis.

Autor:	Abar B; Duke University, Durham, NC, USA., Kim MS; Duke University, Durham, NC, USA., Adams SB; Duke University, Durham, NC, USA., Adams WR; Orthopedic Institute of Western Kentucky, Paducah, USA., Amendola A; Duke University, Durham, NC, USA., Easley ME; Duke University, Durham, NC, USA., Ellington JK; OrthoCarolina, Charlotte, NC, USA., Ford SE; OrthoCarolina, Charlotte, NC, USA., Hanselman AE; Duke University, Durham, NC, USA., Highlander P; The Reconstruction Institute, Bellevue, OH, USA., Kwon JY; Massachusetts General Hospital, Boston, MA, USA., Miller CP; Massachusetts General Hospital, Boston, MA, USA., Nunley JA; Duke University, Durham, NC, USA., Parker C; Renaissance School of Medicine at Stony Brook University, Stony Brook, NY, USA., Parekh SG; Rothman Orthopaedic Institute, Philadelphia, PA, USA., Schweitzer KM; Duke University, Durham, NC, USA., Shawen SB; OrthoCarolina, Charlotte, NC, USA., Mann T; Restor3d, Durham, NC, USA., Kelly C; Restor3d, Durham, NC, USA.
Jazyk:	angličtina
Zdroj:	Foot & ankle international [Foot Ankle Int] 2024 Nov; Vol. 45 (11), pp. 1258-1265. Date of Electronic Publication: 2024 Oct 27.
DOI:	10.1177/10711007241278947
Abstrakt:	Background: Total talus replacement (TTR) implants are designed to replace the diseased talar anatomy, reduce pain, maintain ankle range of motion, and restore ankle function after conservative treatments have failed. Currently TTR implants are produced by 3D printing a patient-specific implant designed from the patient's preoperative anatomy. TTR surgery using patient-specific implants is a relatively new technique that remains understudied in the literature. Therefore, the purpose of this investigation was to determine the early safety and potential benefit of the TTR implant in patients with talar avascular necrosis. Methods: This retrospective, multicenter, cohort study evaluates the safety and potential benefits of TTR using 3D-printed patient-specific implants across 4 US centers. The primary outcome was the occurrence of early adverse events after TTR surgery. Secondary outcomes including, pain, and physical function were assessed using the pain visual analog scale (VAS), and Patient-Reported Outcomes Measurement Information System (PROMIS) physical function (PF), respectively. Results: The study team analyzed 15 patients with more than 1 year of follow-up. The mean duration of follow-up was 25.9 months (range: 18.3-41 months). Although 33.3% (5 of 15) of patients experienced adverse events, primarily occurring within the initial 6 months postoperatively, 93% (14 of 15) of patients reported implant survivorship. Of the 5 cases (33.3%) resulting in an adverse event, 3 (60.0%) were determined to be unrelated to the subject device, 2 (40.0%) were determined to be possibly procedure-related, and none (0%) were determined to be device-related. Conclusion: Although further studies are needed to compare TTR with the standard of care, the results of this study demonstrate the relative early safety of TTR surgery using a 3D-printed implant for the treatment of challenging talar pathologies. A larger and longer clinical study is required to see if the efficacy of this approach will be statistically and clinically meaningful. Competing Interests: 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: Bijan Abar, PhD, reports consulting fees and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Restor3d. Michael Kim reports stock or stock options from Restor3d. Samuel B. Adams, MD, reports support for the present manuscript and royalties or licenses from Restor3d. William R. Adams, DPM, reports consulting fees and stock or stock options from Restor3d. John Kent Ellington, MD, reports royalties or licenses, consulting fees, and stock or stock options from Restor3d. Samuel E. Ford, MD, reports royalties or licenses and stock or stock options from Restor3d. Peter D. Highlander, DPM, MS, reports consulting fees and stock holder from Restor3d Inc, no fees or shares accepted for this manuscript/project. John Y. Kwon, MD, reports royalties or licenses and consulting fees from Restor3D, unrelated to this work. Christopher P. Miller, MD, MHS, reports support for the present manuscript from Restor3D. Selene G. Parekh, MD, MBA, reports grants or contracts, consulting fees, payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events, and stock or stock options from Restor3d. Karl M. Schweitzer, MD, reports stock or stock options from Restor3D, Inc. Scott B. Shawen, MD, reports royalties or licenses, consulting fees, and stock or stock options from Restor3d. Tara Mann, PhD, reports stock or stock options, full-time employee of Restor3d, Inc. with equity in the form of stock and stock options and full-time salary from Restor3d, Inc. Cambre Kelly, PhD, reports leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid and stock or stock options from Restor3d. Disclosure forms for all authors are available online.
Databáze:	MEDLINE
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