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The Spring Distraction System for Growth-Friendly Surgical Treatment of Early Onset Scoliosis: A Preliminary Report on Clinical Results and Safety after Design Iterations in a Prospective Clinical Trial

Background: The Spring Distraction System (SDS) is a dynamic growth-friendly implant to treat early onset scoliosis (EOS). Previous SDS studies showed promising results in terms of curve correction and complication profile. Nevertheless, complications did occur, which led to modifications in the imp...

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Autores principales: Tabeling, Casper S., Lemans, Justin V. C., Top, Anouk, Scholten, E. Pauline, Stempels, Hilde W., Schlösser, Tom P. C., Ito, Keita, Castelein, René M., Kruyt, Moyo C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9267814/
https://www.ncbi.nlm.nih.gov/pubmed/35807030
http://dx.doi.org/10.3390/jcm11133747
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author Tabeling, Casper S.
Lemans, Justin V. C.
Top, Anouk
Scholten, E. Pauline
Stempels, Hilde W.
Schlösser, Tom P. C.
Ito, Keita
Castelein, René M.
Kruyt, Moyo C.
author_facet Tabeling, Casper S.
Lemans, Justin V. C.
Top, Anouk
Scholten, E. Pauline
Stempels, Hilde W.
Schlösser, Tom P. C.
Ito, Keita
Castelein, René M.
Kruyt, Moyo C.
author_sort Tabeling, Casper S.
collection PubMed
description Background: The Spring Distraction System (SDS) is a dynamic growth-friendly implant to treat early onset scoliosis (EOS). Previous SDS studies showed promising results in terms of curve correction and complication profile. Nevertheless, complications did occur, which led to modifications in the implant design. The main iterations were a larger rod diameter and a more sagittal stable sliding mechanism. The purpose of this study was to investigate the performance of these iterations. Methods: All patients treated with the modified SDS and >1 year follow-up were included. Radiographic outcomes, severe adverse events (SAEs), unplanned returns to the operating room (UPRORs) and health-related quality of life (HRQoL) were investigated. Results: Seventeen EOS patients (three congenital, four idiopathic, nine neuromuscular, one syndromic) were included. Mean age at surgery was 9.5 ± 2.5 years. Similar to the first generation SDS, about 50% initial correction was achieved and maintained, and spinal growth was near physiological. Most importantly, SAEs and UPRORs were diminished and favorable with 0.10/patient/year. In addition, HRQoL increased during the first year postoperatively, indicating the implant was well accepted. Conclusion: These preliminary results indicate that the iterations of the SDS are effective in terms of reducing SAEs and UPRORs and increasing HRQoL in patients with EOS.
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spelling pubmed-92678142022-07-09 The Spring Distraction System for Growth-Friendly Surgical Treatment of Early Onset Scoliosis: A Preliminary Report on Clinical Results and Safety after Design Iterations in a Prospective Clinical Trial Tabeling, Casper S. Lemans, Justin V. C. Top, Anouk Scholten, E. Pauline Stempels, Hilde W. Schlösser, Tom P. C. Ito, Keita Castelein, René M. Kruyt, Moyo C. J Clin Med Article Background: The Spring Distraction System (SDS) is a dynamic growth-friendly implant to treat early onset scoliosis (EOS). Previous SDS studies showed promising results in terms of curve correction and complication profile. Nevertheless, complications did occur, which led to modifications in the implant design. The main iterations were a larger rod diameter and a more sagittal stable sliding mechanism. The purpose of this study was to investigate the performance of these iterations. Methods: All patients treated with the modified SDS and >1 year follow-up were included. Radiographic outcomes, severe adverse events (SAEs), unplanned returns to the operating room (UPRORs) and health-related quality of life (HRQoL) were investigated. Results: Seventeen EOS patients (three congenital, four idiopathic, nine neuromuscular, one syndromic) were included. Mean age at surgery was 9.5 ± 2.5 years. Similar to the first generation SDS, about 50% initial correction was achieved and maintained, and spinal growth was near physiological. Most importantly, SAEs and UPRORs were diminished and favorable with 0.10/patient/year. In addition, HRQoL increased during the first year postoperatively, indicating the implant was well accepted. Conclusion: These preliminary results indicate that the iterations of the SDS are effective in terms of reducing SAEs and UPRORs and increasing HRQoL in patients with EOS. MDPI 2022-06-28 /pmc/articles/PMC9267814/ /pubmed/35807030 http://dx.doi.org/10.3390/jcm11133747 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Tabeling, Casper S.
Lemans, Justin V. C.
Top, Anouk
Scholten, E. Pauline
Stempels, Hilde W.
Schlösser, Tom P. C.
Ito, Keita
Castelein, René M.
Kruyt, Moyo C.
The Spring Distraction System for Growth-Friendly Surgical Treatment of Early Onset Scoliosis: A Preliminary Report on Clinical Results and Safety after Design Iterations in a Prospective Clinical Trial
title The Spring Distraction System for Growth-Friendly Surgical Treatment of Early Onset Scoliosis: A Preliminary Report on Clinical Results and Safety after Design Iterations in a Prospective Clinical Trial
title_full The Spring Distraction System for Growth-Friendly Surgical Treatment of Early Onset Scoliosis: A Preliminary Report on Clinical Results and Safety after Design Iterations in a Prospective Clinical Trial
title_fullStr The Spring Distraction System for Growth-Friendly Surgical Treatment of Early Onset Scoliosis: A Preliminary Report on Clinical Results and Safety after Design Iterations in a Prospective Clinical Trial
title_full_unstemmed The Spring Distraction System for Growth-Friendly Surgical Treatment of Early Onset Scoliosis: A Preliminary Report on Clinical Results and Safety after Design Iterations in a Prospective Clinical Trial
title_short The Spring Distraction System for Growth-Friendly Surgical Treatment of Early Onset Scoliosis: A Preliminary Report on Clinical Results and Safety after Design Iterations in a Prospective Clinical Trial
title_sort spring distraction system for growth-friendly surgical treatment of early onset scoliosis: a preliminary report on clinical results and safety after design iterations in a prospective clinical trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9267814/
https://www.ncbi.nlm.nih.gov/pubmed/35807030
http://dx.doi.org/10.3390/jcm11133747
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