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
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.
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.
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.
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.
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.
KeywordsBack pain Balloon kyphoplasty Osteoporosis SpineJack Vertebral augmentation Vertebral compression fracture
Compliance with ethical standards
Conflicts of interest
- 6.Majumdar SR, Kim N, Colman I, Chahal AM, Raymond G, Jen H, Siminoski KG, Hanley DA, Rowe BH (2005) Incidental vertebral fractures discovered with chest radiography in the emergency department: prevalence, recognition, and osteoporosis management in a cohort of elderly patients. Arch Intern Med 165(8):905–909CrossRefGoogle Scholar
- 10.NICE Guidance. Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for treating osteoporotic vertebral compression fractures. Technology appraisal guidance [TA279], 24 April 2013. https://www.nice.org.uk/guidance/ta279
- 17.Noriega DC, Ramajo RH, Lite IS, Toribio B, Corredera R, Ardura F, Krüger A (2016) Safety and clinical performance of kyphoplasty and SpineJack procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study. Osteoporos Int 27(6):2047–2055CrossRefGoogle Scholar
- 20.Brooks R, Rabin R, Charro F (2003) The measurement and valuation of health status using EQ-5D: a European perspective. Evidence from the EuroQol BIOMED Research programme. Editors: Brooks, Richard, Rabin, Rosalind, de CharroGoogle Scholar
- 22.MedDRA term selection: points to consider. ICH endorsed guide for MedDRA users. Release 4.2, based on MedDRA Version 14.1, October 2011. http://www.meddra.org/sites/default/files/guidance/file/9491-1410_termselptc_r4_2_sep2011.pdf
- 29.Van Meirhaeghe J, Bastian L, Boonen S, Ranstam J, Tillman JB, Wardlaw D (2013) FREE investigators. A randomized trial of balloon kyphoplasty and nonsurgical management for treating acute vertebral compression fractures: vertebral body kyphosis correction and surgical parameters. Spine (Phila Pa 1976) 38(12):971–983CrossRefGoogle Scholar
- 32.Tutton SM, Pflugmacher R, Davidian M, Beall DP, Facchini FR, Garfin SR (2015) KAST study: the kiva® system as a vertebral augmentation treatment - a safety and effectiveness trial: a randomized, non-inferiority trial comparing the kiva® system to balloon kyphoplasty in treatment of osteoporotic vertebral compression fractures. Spine (Phila Pa 1976) 40:865–875CrossRefGoogle Scholar
- 36.Faloon MJ, Ruoff M, Deshpande C, Hohman D, Dunn C, Beckloff N, Patel DV (2015) Risk factors associated with adjacent and remote- level pathologic vertebral compression fracture following balloon kyphoplasty: 2-year follow-up comparison versus conservative treatment. J Long-Term Eff Med Implants 25(4):313–319CrossRefGoogle Scholar
- 37.Wardlaw D, Cummings SR, Van Meirhaeghe J, Bastian L, Tillman JB, Ranstam J, Eastell R, Shabe P, Talmadge K, Boonen S (2009) Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet 373(9668):1016–1024CrossRefGoogle Scholar