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Osteoporosis International

, Volume 30, Issue 3, pp 637–645 | Cite as

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

  • D. C. NoriegaEmail author
  • F. Rodrίguez-Monsalve
  • R. Ramajo
  • I. Sánchez-Lite
  • B. Toribio
  • F. Ardura
Original Article

Abstract

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.

Keywords

Back pain Balloon kyphoplasty Osteoporosis SpineJack Vertebral augmentation Vertebral compression fracture 

Notes

Compliance with ethical standards

Conflicts of interest

None.

Supplementary material

198_2018_4773_MOESM1_ESM.odt (84 kb)
ESM 1 (ODT 84 kb)
198_2018_4773_MOESM2_ESM.odt (15 kb)
ESM 2 (ODT 14 kb)

References

  1. 1.
    Van der Klift M, De Laet CE, McCloskey EV, Hofman A, Pols HA (2002) The incidence of vertebral fractures in men and women: the Rotterdam study. J Bone Miner Res 17:1051–1056CrossRefGoogle Scholar
  2. 2.
    Ballane G, Cauley JA, Luckey MM, El-Hajj Fuleihan G (2015) Worldwide prevalence and incidence of osteoporotic vertebral fractures. Osteoporos Int 28(5):1531–1542CrossRefGoogle Scholar
  3. 3.
    Johnell O, Kanis JA (2006) An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int 17(12):1726–1733CrossRefGoogle Scholar
  4. 4.
    Lindsay R, Burge RT, Strauss DM (2005) One-year outcomes and costs following a vertebral fracture. Osteoporos Int 16:78–85CrossRefGoogle Scholar
  5. 5.
    Lau E, Ong K, Kurtz S, Schmier J, Edidin A (2008) Mortality following the diagnosis of a vertebral compression fracture in the Medicare population. J Bone Joint Surg Am 90:1479–1486CrossRefGoogle Scholar
  6. 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
  7. 7.
    European Prospective Osteoporosis Study (EPOS) Group, Felsenberg D, Silman AJ, Lunt M et al (2002) Incidence of vertebral fractures in Europe: results from the European Prospective Osteoporosis Study (EPOS). J Bone Miner Res 17:716–724CrossRefGoogle Scholar
  8. 8.
    Han SL, Wan SL, Li QT, Xu DT, Zang HM, Chen NJ, Chen LY, Zhang WP, Luan C, Yang F, Xu ZW (2015) Is vertebroplasty a risk factor for subsequent vertebral fracture, meta-analysis of published evidence? Osteoporos Int 26:113–122CrossRefGoogle Scholar
  9. 9.
    Klazen CA, Verhaar HJ, Lohle PN, Lampmann LE, Juttmann JR, Schoemaker MC, van Everdingen KJ, Muller AF, Mali WP, de Vries J (2010) Clinical course of pain in acute osteoporotic vertebral compression fractures. J Vasc Interv Radiol 21:1405–1409CrossRefGoogle Scholar
  10. 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
  11. 11.
    Papanastassiou ID, Filis A, Gerochristou MA, Vrionis FD (2014) Controversial issues in kyphoplasty and vertebroplasty in osteoporotic vertebral fractures. Biomed Res Int 2014:934206Google Scholar
  12. 12.
    Edidin AA, Ong KL, Lau E, Schmier JK, Kemner JE, Kurtz SM (2012) Cost-effectiveness analysis of treatments for vertebral compression fractures. Appl Health Econ Health Policy 10:273–284CrossRefGoogle Scholar
  13. 13.
    Chen AT, Cohen DB, Skolasky RL (2013) Impact of nonoperative treatment, vertebroplasty, and kyphoplasty on survival and morbidity after vertebral compression fracture in the Medicare population. J Bone Joint Surg Am 95:1729–1736CrossRefGoogle Scholar
  14. 14.
    Vanni D, Galzio R, Kazakova A, Pantalone A, Grillea G, Bartolo M, Salini V, Magliani V (2016) Third-generation percutaneous vertebral augmentation systems. J Spine Surg 2(1):13–20CrossRefGoogle Scholar
  15. 15.
    Krüger A, Baroud G, Noriega D, Figiel J, Dorschel C, Ruchholtz S, Oberkircher L (2013) Height restoration and maintenance after treating unstable osteoporotic vertebral compression fractures by cement augmentation is dependent on the cement volume used. Clin Biomech 28:725–730CrossRefGoogle Scholar
  16. 16.
    Krüger A, Oberkircher L, Figiel J, Floßdorf F, Bolzinger F, Noriega DC, Ruchholtz S (2015) Height restoration of osteoporotic vertebral compression fractures using different intravertebral reduction devices: a cadaveric study. Spine J 15:1092–1098CrossRefGoogle Scholar
  17. 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
  18. 18.
    Vanni D, Pantalone A, Bigossi F, Pineto F, Lucantoni D, Salini V (2012) New perspective for third generation percutaneous vertebral augmentation procedures: preliminary results at 12 months. J Craniovertebr Junction Spine 3:47–51CrossRefGoogle Scholar
  19. 19.
    Vogler D, Paillex R, Norberg M, de Goumoëns P, Cabri J (2008) Cross-cultural validation of the Oswestry disability index in French. Ann Readapt Med Phys 51:379–385CrossRefGoogle Scholar
  20. 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
  21. 21.
    Schulze M, Trautwein F, Vordemvenne T, Raschke M, Heuer F (2011) A method to perform spinal motion analysis from functional X-ray images. J Biomech 44:1740–1746CrossRefGoogle Scholar
  22. 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
  23. 23.
    Genant HK, Wu CY, van Kuijk C, Nevitt MC (1993) Vertebral fracture assessment using a semiquantitative technique. J Bone Miner Res 8(9):1137–1148CrossRefGoogle Scholar
  24. 24.
    Yeom JS, Kim WJ, Choy WS, Lee CK, Chang BS, Kang JW (2003) Leakage of cement in percutaneous transpedicular vertebroplasty for painful osteoporotic compression fractures. J Bone Joint Surg Br 85(1):83–89CrossRefGoogle Scholar
  25. 25.
    Walters SJ, Brazier JE (2005) Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res 14:1523–1532CrossRefGoogle Scholar
  26. 26.
    Le QA, Doctor JN, Zoellner LA, Feeny NC (2013) Minimal clinically important differences for the EQ-5D and QWB-SA in Post-traumatic Stress Disorder (PTSD): results from a Doubly Randomized Preference Trial (DRPT). Health Qual Life Outcomes 11:59CrossRefGoogle Scholar
  27. 27.
    Collins SL, Moore RA, McQuay HJ (1997) The visual analogue pain intensity scale: what is moderate pain in millimetres? Pain 72:95–97CrossRefGoogle Scholar
  28. 28.
    Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M, Bouter LM, de Vet HC (2008) Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine (Phila Pa 1976) 33:90–94CrossRefGoogle Scholar
  29. 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
  30. 30.
    Zhang H, Xu C, Zhang T, Gao Z, Zhang T (2017) Does percutaneous vertebroplasty or balloon kyphoplasty for osteoporotic vertebral compression fractures increase the incidence of new vertebral fractures? A meta-analysis. Pain Physician 20(1):E13–E28Google Scholar
  31. 31.
    Yi X, Lu H, Tian F, Wang Y, Li C, Liu H, Liu X, Li H (2014) Recompression in new levels after percutaneous vertebroplasty and kyphoplasty compared with conservative treatment. Arch Orthop Trauma Surg 134:21–30CrossRefGoogle Scholar
  32. 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
  33. 33.
    Dohm M, Black C, Dacre A, Tillman JB, Fueredi G, KAVIAR investigators (2014) A randomized trial comparing balloon kyphoplasty and vertebroplasty for vertebral compression fractures (VCFs) due to osteoporosis. AJNR 35(12):2227–2236CrossRefGoogle Scholar
  34. 34.
    Liu JT, Li CS, Chang CS, Liao WJ (2015) Long-term follow-up study of osteoporotic vertebral compression fracture treated using balloon kyphoplasty and vertebroplasty. J Neurosurg Spine 23(1):94–98CrossRefGoogle Scholar
  35. 35.
    Baz AB, Akalin S, Kiliçaslan ÖF, Tokatman B, Arik H, Duygun F (2016) Efficiency of balloon kyphoplasty in the treatment of osteoporotic vertebral compression fractures. Kobe J Med Sci 62(3):E49–E54Google Scholar
  36. 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. 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
  38. 38.
    Deibert CP, Gandhoke GS, Paschel EE, Gerszten PC (2016) A longitudinal cohort investigation of the development of symptomatic adjacent level compression fractures following balloon-assisted kyphoplasty in a series of 726 patients. Pain Physician 19(8):E1167–E1172Google Scholar

Copyright information

© International Osteoporosis Foundation and National Osteoporosis Foundation 2018
corrected publication 2019

Authors and Affiliations

  1. 1.Hospital Clinico Universitario de ValladolidValladolidSpain

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