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    Por favor, use este identificador para citar o enlazar este ítem:http://uvadoc.uva.es/handle/10324/44980

    Título
    A prospective, international, randomized, noninferiority study comparing an implantable titanium vertebral augmentation device versus balloon kyphoplasty in the reduction of vertebral compression fractures (SAKOS study)
    Autor
    Noriega González, David CésarAutoridad UVA
    Marcia, Stefano
    Theumann, Nicolas
    Blondel, Benjamin
    Simon, Alexandre
    Hassel, Frank
    Maestretti, Gianluca
    Petit, Antoine
    Weidle, Patrick A.
    González Mandly, Andrés
    Kaya, Jean-Marc
    Touta, Adamou
    Fuentes, Stéphane
    Pflugmacher, Robert
    Año del Documento
    2019
    Editorial
    Elsevier
    Descripción
    Producción Científica
    Documento Fuente
    The Spine Journal, 2019, vol. 19, n. 11. p. 1782-1795
    Abstract
    Background context: Balloon kyphoplasty (BKP) is a commonly performed vertebral augmentation procedure for painful osteoporotic vertebral compression fractures (OVCFs). Objective: This study aimed to support a non-inferiority finding for the use of a titanium implantable vertebral augmentation device (TIVAD) compared to BKP. Study design: Prospective, parallel group, controlled comparative randomized study. Patient sample: Patients who presented with one or two painful OVCFs located between T7 and L4 aged <3 months, failed conservative treatment, and had an Oswestry Disability Index (ODI) score ≥30/100 were eligible for the study. Results: Among the 141 patients (78.7% female, mean age 73.3±9.5 years) who underwent surgery (TIVAD=68; BKP=73), 126 patients (89.4%) completed the 12-month follow-up period (TIVAD=61; BKP=65). The analysis of primary endpoint on the ITT population demonstrated non-inferiority of the TIVAD to BKP. The analysis of the additional composite endpoint demonstrated the superiority of TIVAD over BKP (p<0.0001) at 6 months (88.1% vs. 60.9%) and at 12 months (79.7% vs. 59.3%). Midline VB height restoration was more improved for TIVAD than for BKP at 6 months (1.14±2.61 mm vs. 0.31±2.22 mm); p=0.0246) and 12 months after surgery (1.31±2.58 mm vs. 0.10±2.34 mm; p=0.0035). No statistically significant differences were shown between procedures for improvement in functional capacity and quality of life. Pain relief was significantly more marked in the TIVAD group compared to the BKP group at 1 month (p=0.029) and at 6 months (p=0.021) after surgery. No patient required surgical reintervention or retreatment at the treated level. No symptomatic cement leakage was reported. Adverse events were similar for both groups (41.2% in the TIVAD group and 45.2% in the BKP group). The incidence of adjacent fractures was significantly lower after the TIVAD procedure than after BKP (12.9% vs. 27.3%; p=0.043). Conclusions: Study results demonstrated non-inferiority of the TIVAD to the predicate BKP with an excellent risk/benefit profile for results up to 12 months.
    Palabras Clave
    Adjacent fractures
    Fracturas adyacentes
    Balloon kyphoplasty
    Cifoplastia con balón
    Osteoporosis
    Spine surgery
    Cirugía de columna
    ISSN
    1529-9430
    Revisión por pares
    SI
    DOI
    10.1016/j.spinee.2019.07.009
    Version del Editor
    https://www.sciencedirect.com/science/article/pii/S1529943019308794?via%3Dihub
    Propietario de los Derechos
    © 2019 Elsevier
    Idioma
    eng
    URI
    http://uvadoc.uva.es/handle/10324/44980
    Tipo de versión
    info:eu-repo/semantics/publishedVersion
    Derechos
    openAccess
    Aparece en las colecciones
    • CFC - Artículos de Revista [38]
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    Attribution-NonCommercial-NoDerivatives 4.0 InternacionalLa licencia del ítem se describe como Attribution-NonCommercial-NoDerivatives 4.0 Internacional

    Universidad de Valladolid

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