Common Design, Data Elements and Core Outcome Measures Reported on Clinical Trials of Genicular Artery Embolization for Knee Osteoarthritis: An Interactive Systematic Review.

Genicular artery embolization (GAE) is an emerging, potentially effective treatment option in patients with knee osteoarthritis (OA). This study aimed to describe the current state of common design data elements (CDDEs) and core outcome measures (COMs) in recent trials of GAE for knee OA. A comprehensive search of seven online databases were searched within the Nested Knowledge AutoLit living review platform, followed by categorization of primary and secondary outcomes. Studies were tagged with the relevant outcomes of interest in each article. Results were synthesized and examined for the CDDEs. Pain is the most frequent reported outcome, present in 23 of the 24 studies (95.8%). However, there is considerable variability in the description of in the study designs, procedural techniques, embolic materials, time points, and MRI parameters. Greater consistency is observed in eligibility criteria, and adverse events reporting. Although findings thus far have been favorable, current data is still constrained by the heterogeneity of the study design, embolization area nomenclature, limited follow-up, and in many cases, the absence of control group. To enhance the potential for future meta-analyses and robust, evidence-based evaluations of GAE as a treatment for knee OA, further research is required to address the identified shortcomings. By establishing more standardized protocols, the efficacy and safety of GAE can be more accurately assessed and understood.

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Copyright © 2023 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest MLB, SG, and HK declare no conflict of interests. ST reports consulting fees to Mayo Clinic from Boston Scientific. RK receives funding from: Cerenovus Inc, Medtronic, Endovascular Engineering, Frontior Bio, Sensome Inc, Endomimetics, Ancure LLC, Neurogami Medical, MIVI Biosciences, Monarch Biosciences, Stryker Inc, Conway Medical, Pireus Medical, Bionau Labs. DK has the following conflicts: ownership in Monarch Biosciences Inc, Nested Knowledge Inc, Superior Medical Experts Inc, Marblehead Medical Inc, Conway Medical LLC and Piraeus Medical; Royalties from Medtronic, patents for balloon guide technology, participation on data safety monitoring for NoNO Inc and Vesalio, software use for Brainomix, research support from Brainomix, Cerenovus, Insera Therapeutics, Medtronic, Microvention, Balt, and Monarch Biosciences.