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
ARTICLE HIGHLIGHTS
Research background

Osteochondral lesions of the Talus (OLT) are pathologic lesions of the talar cartilage and the subchondral bone. These lesions can occur in up to 50% of acute ankle fractures and sprains. For OLTs of larger size (i.e., above 10 or 15 mm in diameter) and of non-fragmentous morphology, the ‘standard’ operative treatment options such as autologous chondrocyte implantation, osteochondral autograft transfer systems, and a Talar OsteoPeriostic grafting from the Iliac Crest procedure may result in satisfactory clinical outcomes. However, in some patients, there are multiple secondary lesions present of large and cystic nature. For these lesions, it is not always possible to harvest an osteo(chondral) autograft that is large enough to replace all the diseased osteochondral tissue of the talus without damaging the donor site or compromising the congruency of the ankle joint. Allograft treatment could be considered for the treatment of these type of lesions. However, these contain the disadvantages of loss of viability and stability in one-third of the grafts, and possibly clinically fail due to immunological reactions. However, when there are multiple secondary (i.e., failed prior surgery) lesions present on the talar articular surface in combination with a large and cystic nature, the above-described operative interventions are to be expected to result in relatively inferior outcomes.

Research motivation

Currently, it is difficult to treat patients with osteochondral lesions of the ankle that are of multiple, cystic and secondary nature. This is because the lesions are considered relatively large and difficult to treat. For this indication, it was usually performed to fuse the ankle joint. However, in the past 2 to 5 years, novel innovative surgical options have been developed, such as the Ankle Spacer, in order to overcome an ankle fusion or ankle prosthesis.

Research objectives

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

Research methods

In a prospective study including patients with multiple, cystic or large osteochondral lesions of the talus were included who failed previous surgical treatment. We looked at the numeric rating scale (NRS) for pain during walking at 2 years after implantation of the Ankle Spacer and we also assessed the NRS in rest and during stair-climbing, the American Orthopaedic Foot and Ankle Outcome Score, the Foot and Ankle Outcome Score, the Short-Form 36 and the range of motion of the ankles both pre-operatively as well as post-operatively. Radiographic evaluations were conducted to evaluate prosthetic loosening and subsidence. Revision rates and complications were also assessed.

Research results

In this prospective study, two patients underwent the implantation of an Ankle Spacer for osteochondral damage on the talar dome. We found that there were clinically relevant pain reductions during walking as well as important improvements in clinical outcomes as assessed with the patient-reported outcome measures. Furthermore, it was found that there were no complications nor re-operations.

Research conclusions

The Ankle Spacer showed good clinical outcomes and clinically relevant pain reduction during walking, improvement in clinical outcomes as assessed with PROMs, and no complications or re-operations. This treatment option may therefore evolve as a joint-sparing alternative to an ankle arthrodesis, a total talar implant or a total ankle arthroplasty/resurfacing.

Research perspectives

Future research should be focused at the development of a prospective, self-learning algorithm taking into account the individual patient factors influencing outcomes after conservative and surgical treatment so that we can assess which patients would benefit most from which treatment options.