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©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
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
BACKGROUND
Adolescent idiopathic scoliosis remains a major problem due to its high incidence, high risk, and high cost. One of the aims of the management in scoliosis is to correct the deformity. Many techniques are available to correct scoliosis deformity; however, they are all far from ideal to achieve three-dimensional correction in scoliosis.
AIM
To develop a set of tools named Scoliocorrector Fatma-UI (SCFUI) to aid three-dimensional correction and to evaluate the efficacy, safety, and functional outcome.
METHODS
This study consists of two stages. In the first stage, we developed the SCFUI and tested it in finite element and biomechanical tests. The second stage was a single-blinded randomized clinical trial to evaluate the SCFUI compared to direct vertebral rotation (DVR). Forty-four subjects with adolescent idiopathic scoliosis were randomly allocated into the DVR group (n = 23) and SCFUI group (n = 21). Radiological, neurological, and functional outcome was compared between the groups.
RESULTS
Finite element revealed the maximum stress of the SCFUI components to be between 31.2 - 252 MPa. Biomechanical analysis revealed the modulus elasticity of SCFUI was 9561324 ± 633277 MPa. Both groups showed improvement in Cobb angle and sagittal profile, however the rotation angle was lower in the SCFUI group (11.59 ± 7.46 vs 18.23 ± 6.39, P = 0.001). Neurological and functional outcome were comparable in both groups.
CONCLUSION
We concluded that SCFUI developed in this study resulted in similar coronal and sagittal but better rotational correction compared to DVR. The safety and functional outcomes were also similar to DVR.
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.
