RT info:eu-repo/semantics/article
T1 Long-term safety and clinical performance of kyphoplasty and SpineJack® procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study
A1 Noriega González, David César
A1 Rodrίguez Monsalve, F.
A1 Ramajo, R.
A1 Sánchez Lite, Israel
A1 Toribio Calvo, Borja
A1 Ardura Aragón, Francísco
K1 Back pain
K1 Dolor de espalda
K1 Balloon kyphoplasty
K1 Cifoplastia con balón
K1 Osteoporosis
K1 Vertebral augmentation
K1 Vertebroplastia percutánea
AB Summary: This pilot monocenter study in 30 patients with painful osteoporotic vertebral compression fractures compared two vertebral augmentation procedures. Over a 3-year post-surgery follow-up, pain/disability/quality of life remained significantly improved with both balloon kyphoplasty and SpineJack® techniques, but the latter allowed better vertebral body height restoration/kyphosis correction. Introduction: Patient follow-up rarely exceed 2 years in trials comparing vertebral augmentation procedures for the treatment of painful osteoporotic vertebral compression fractures (VCFs). This pilot, investigator-initiated, prospective study aimed to compare long-term results of SpineJack® (SJ) and balloon kyphoplasty (BKP). Preliminary results showed that SJ resulted in a better restoration of vertebral heights and angles, maintained over 12 months. Methods: Thirty patients were randomized to SJ (n = 15) or BKP (n = 15). Clinical endpoints were analgesic consumption, back pain intensity (visual analog scale (VAS)), the Oswestry Disability Index (ODI), and quality of life (EQ-VAS score). They were recorded preoperatively, at 5 days (except EQ-VAS), 1, 3, 6, 12, and 36 months post-surgery. Spine X-rays were taken 48 h prior to the procedure and 5 days, 6, 12, and 36 months after. Results: Clinical improvements were observed with both procedures over the 3-year period without significant inter-group differences, but the final mean EQ-5Dindex score was significantly in favor of the SJ group (0.93 ± 0.11 vs 0.81 ± 0.09; p = 0.007). Vertebral height restoration/kyphotic correction was still evident at 36 months with a greater mean correction of anterior (10 ± 13% vs 2 ± 8% for BKP, p = 0.007) and central height (10 ± 11% vs 3 ± 7% for BKP, p = 0.034) and a larger correction of the vertebral body angle (− 5.0° ± 5.1° vs 0.4° ± 3.4°; p = 0.003) for SJ group. Conclusions: In this study, both techniques displayed very good long-term clinical efficiency and safety in patients with osteoporotic VCFs. Over the 3-year follow-up, vertebral body height restoration/kyphosis correction was better with the SpineJack® procedure.
PB Springer Link
SN 1433-2965
YR 2019
FD 2019
LK http://uvadoc.uva.es/handle/10324/44981
UL http://uvadoc.uva.es/handle/10324/44981
LA eng
NO Osteoporosis International, 2019, vol. 30. p. 637-645
NO Producción Científica
DS UVaDOC
RD 26-abr-2024