Prospective Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Orthop. Feb 18, 2022; 13(2): 178-192
Published online Feb 18, 2022. doi: 10.5312/wjo.v13.i2.178
Clinical efficacy of the Ankle Spacer for the treatment of multiple secondary osteochondral lesions of the talus
Jari Dahmen, J Nienke Altink, Gwendolyn Vuurberg, Coen A Wijdicks, Sjoerd AS Stufkens, Gino MMJ Kerkhoffs
Jari Dahmen, J Nienke Altink, Gwendolyn Vuurberg, Sjoerd AS Stufkens, Gino MMJ Kerkhoffs, Department of Orthopedic Surgery, Amsterdam UMC, Location AMC, Amsterdam 1105AZ, Netherlands
Coen A Wijdicks, Department of Orthopedic Research, Arthrex, Naples, FL 34108, United States
Author contributions: Dahmen J, Altink JN, Vuurberg G, Wijdicks C, Stufkens S and Kerkhoffs G have made substantial contributions to conception and design, acquisition of data, analysis and interpretation of data, and have been involved in drafting the manuscript; Dahmen J and Altink JN have been involved in the acquisition of data; all authors have been involved in revising the manuscript, critically for important intellectual content, and have given final approval of the version to be published.
Institutional review board statement: The study was approved by the local Medical Ethics Committee (Internal Review Board, IRB) of the Amsterdam University Medical Centre with reference number MEC 2017_175 and was performed in accordance with the principles of the Declaration of Helsinki and the medical Research Involving Human Subjects Act (WMO).
Informed consent statement: All patients provided informed consent prior to the participation in the study.
Conflict-of-interest statement: The study was sponsored by Arthrex as a post market study with reference number EMEA-17037.
Data sharing statement: No additional data available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Jari Dahmen, MD, BSc, Doctor, PhD-Candidate, Research Fellow, Senior Researcher, Department of Orthopedic Surgery, Amsterdam UMC, location AMC, Meibergdreef 9, Amsterdam 1105AZ, Netherlands. j.dahmen@amsterdamumc.nl
Received: July 30, 2021
Peer-review started: July 30, 2021
First decision: November 11, 2021
Revised: November 18, 2021
Accepted: January 6, 2022
Article in press: January 6, 2022
Published online: February 18, 2022
Abstract
BACKGROUND

The Ankle Spacer was developed as a joint-sparing alternative to invasive end-stage surgeries. Currently, there are no clinical studies on the Ankle Spacer.

AIM

To describe the operative technique and the clinical efficacy of the Ankle Spacer for the treatment of multiple, cystic osteochondral lesions of the talus in patients with failed prior operative treatment.

METHODS

This is a prospective study during which patients were assessed preoperatively, at 2- and 6 wk, and at 3, 6, 12 and 24 mo postoperatively. Patients with multiple, cystic or large (≥ 15 mm) osteochondral lesions of the talus after failed prior surgery were included. The primary outcome measure was the numeric rating scale (NRS) for pain during walking at 2 years postoperatively. Secondary outcome measures included the NRS in rest and during stair climbing, the American Orthopaedic Foot and Ankle Society Hindfoot Score, the Foot and Ankle Outcome Score, the Short- Form 36 physical and mental component scale, and the Range of Motion (ROM). Radiographic evaluations were conducted to evaluate prosthetic loosening and subsidence. Revision rates and complications were also assessed.

RESULTS

Two patients underwent an Ankle Spacer implantation on the talus. The NRS during walking improved from 6 and 7 preoperatively to 2 and 2 points postoperatively at 2 years, in patient 1 and 2, respectively. The other patient-reported outcome measures also improved substantially. There were no re-operations nor complications. Radiological imaging showed no loosening of the implant and no change of implant position.

CONCLUSION

The Ankle Spacer showed clinically relevant pain reduction during walking, improvement in clinical outcomes as assessed with PROMs, and no complications or re-operations. This treatment option may evolve as a joint-sparing alternative to invasive end-stage surgeries.

Keywords: Hemi-arthroplasty, Ankle Spacer, Talar surface implant, Osteochondral lesions of the talus, End-stage

Core Tip: Our aim was to provide an overview of the clinical efficacy of a novel implant system that is a hemi-arthroplasty of the ankle. This device can be used for multiple, secondary osteochondral lesions of the talus and isolated osteo-arthritis of the talar dome. In this prospective case series, it was shown that this novel device showed promising clinical outcomes and can be considered safe.