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

Autor: Casper S. Tabeling, Justin V. C. Lemans, Anouk Top, E. Pauline Scholten, Hilde W. Stempels, Tom P. C. Schlösser, Keita Ito, René M. Castelein, Moyo C. Kruyt
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Journal of Clinical Medicine; Volume 11; Issue 13; Pages: 3747
ISSN: 2077-0383
DOI: 10.3390/jcm11133747
Popis: 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.
Databáze: OpenAIRE
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