Randomized Clinical Trial
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Orthop. Jan 18, 2024; 15(1): 61-72
Published online Jan 18, 2024. doi: 10.5312/wjo.v15.i1.61
Scoliocorrector Fatma-UI for correction of adolescent idiopathic scoliosis: Development, effectivity, safety and functional outcome
Phedy Phedy, Ismail Hadisoebroto Dilogo, Wresti Indriatmi, Sugeng Supriadi, Marcel Prasetyo, Fitri Octaviana, Zairin Noor
Phedy Phedy, Doctoral Program in Medical Sciences Faculty of Medicine, University of Indonesia, Jakarta Pusat 10430, DKI Jakarta, Indonesia
Ismail Hadisoebroto Dilogo, Department of Orthopaedic and Traumatology, Universitas Indonesia, Jakarta 10430, DKI Jakarta, Indonesia
Wresti Indriatmi, Department of Dermatology and Venereology, Faculty of Medicine, University of Indonesia, Jakarta Pusat 10430, DKI Jakarta, Indonesia
Sugeng Supriadi, Faculty of Mechanical Engineering, University of Indonesia, Depok 16424, Jawa Barat, Indonesia
Marcel Prasetyo, Department of Radiology, University of Indonesia, Jakarta Pusat 10430, DKI Jakarta, Indonesia
Fitri Octaviana, Department of Neurology, Faculty of Medicine, University of Indonesia, Jakarta Pusat 10430, DKI Jakarta, Indonesia
Zairin Noor, Research Center for Osteoporosis, Department of Orthopaedic and Traumatology, Lambung Mangkurat University, Banjarmasin 70123, Kalimantan Selatan, Indonesia
Author contributions: Phedy P contributed to the concepts, design, studies, data acquisition, data analysis, statistical analysis, manuscript preparation and review; Dilogo IH contributed to the design, studies, manuscript preparation and review; Indriatmi W contributed to the data analysis, statistical analysis, manuscript preparation and review; Supriadi S, Prasetyo M, and Octaviana F contributed equal contributions to study conception and design, data acquisition, data analysis, manuscript preparation and review; Noor Z contributed to the design, concept, clinical study, manuscript preparation and review.
Institutional review board statement: The study was reviewed and approved by the Ethical Committee Faculty of Medicine, University of Indonesia (Approval No. KET-615/UN2.F1/ETIK/PPM.00.02/2020) and Ethical Committee of Fatmawati General Hospital (Approval No. DM 01.01/VIII.2/1294/2020).
Clinical trial registration statement: This study was not registered on clinicaltrial.gov but it was registered with the University’s ethical committee and hospital ethical committee prior to the study.
Informed consent statement: Informed consent was obtained prior to the study. The inform consent form was approved by the Ethical Committee Faculty of Medicine, University of Indonesia (Approval No. KET-615/UN2.F1/ETIK/PPM.00.02/2020).
Conflict-of-interest statement: The authors declare that they have no conflicts of interest.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at phedy.phe@gmail.com.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
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 Non-Commercial (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: Phedy Phedy, MD, Surgeon, Doctoral Program in Medical Sciences Faculty of Medicine, University of Indonesia, Jl. Salemba Raya No. 6, Jakarta Pusat 10430, DKI Jakarta, Indonesia. Phedy.phe@gmail.com
Received: October 23, 2023
Peer-review started: October 23, 2023
First decision: November 29, 2023
Revised: December 1, 2023
Accepted: December 27, 2023
Article in press: December 27, 2023
Published online: January 18, 2024
Processing time: 84 Days and 22.6 Hours
Core Tip

Core Tip: We developed a novel set of tools to aid in the three-dimensional correction of adolescent idiopathic scoliosis. We performed finite element and biomechanical tests on the tools and evaluated its radiological, neurological and functional outcomes in a randomized clinical trial to ensure its efficacy and safety.