RT info:eu-repo/semantics/article
T1 Clinical performance and safety of 108 SpineJack implantations: 1-year results of a prospective multicentre single-arm registry study
A1 Noriega González, David César
A1 Maestretti, Gianluca
A1 Renaud, Christian
A1 Francaviglia, Natale
A1 Ould-Slimane, Mourad
A1 Queinnec, Steffen
A1 Ekkerlein, Helmut
A1 Hassel, Frank
A1 Gumpert, Rainer
A1 Sabatier, Pascal
A1 Huet, Hervé
A1 Plasencia, Miguel
A1 Theumann, Nicolas
A1 Kunsky, Alexander
A1 Krüger, Antonio
K1 Vertebral compression fracture
K1 Fractura vertebral por compresión
K1 SpineJack system
K1 Sistema SpineJack
AB This prospective, consecutive, multicentre observational registry aimed to confirm the safety and clinical performance of the SpineJack system for the treatment of vertebral compression fractures (VCF) of traumatic origin. We enrolled 103 patients (median age: 61.6 years) with 108 VCF due to trauma, or traumatic VCF with associated osteoporosis. Primary outcome was back pain intensity (VAS). Secondary outcomes were Oswestry Disability Index (ODI), EuroQol-VAS, and analgesic consumption. 48 hours after surgery, a median relative decrease in pain intensity of 81.5% was observed associated with a significant reduction in analgesic intake. Improvements in disability (91.3% decrease in ODI score) and in quality of life (increase 21.1% of EQ-VAS score) were obtained 3 months after surgery. All results were maintained at 12 months. A reduction in the kyphotic angulation was observed postoperatively (−5.4 ± 6.3∘ ; p< 0.001), remained at 12 months (−4.4 ± 6.0∘ , p = 0.002). No adverse events were implant-related and none required device removal. Three patients (2.9%) experienced procedure-related complications. The overall adjacent fracture rate up to 1 year after surgery was 2.9%. The SpineJack procedure is an effective, low-risk procedure for patients with traumatic VCF allowing a fast and sustained improvement in quality of life over 1 year after surgery.
PB Hindawi
SN 2314-6141
YR 2015
FD 2015
LK http://uvadoc.uva.es/handle/10324/44995
UL http://uvadoc.uva.es/handle/10324/44995
LA eng
NO BioMed Research International, 2015, vol. 2015. 10 p.
NO Producción Científica
DS UVaDOC
RD 22-dic-2024