Clinical results of an open prospective study of a bis-GMA composite in percutaneous vertebral augmentation

Abstract

In this open prospective trial, 53 patients with acute pain from osteoporotic vertebral fracture related to osteoporosis or malignancy underwent vertebral augmentation with a new bisphenol-a-glycidyl dimethacrylate (bis-GMA) resin (Cortoss, Orthovita, Malvern, Pa, USA). Treatment consisted of up to 8 ml of Cortoss injected into a given vertebra. The procedure encompassed single and multiple injections (including the contralateral hemivertebra, to a maximum of 3 vertebral levels). Follow-up was at 4 and 8 days and at 1, 3, and 6 months. The primary efficacy end point was patient-rated pain using a 100-point visual analog scale (VAS, with 100 as severest pain) on day 4 following treatment; secondary end points were analgesic use and quality-of-life and disability scores from the Oswestry Disability Index (ODI) and a short-form 12-item questionnaire (SF-12). The present report contains interim results collected up to the 1-month post-treatment time point. At baseline, the group’s mean VAS score was 69, indicating moderate to severe pain; at day 4, 32 of 53 patients (60.4%) reported a 30% or greater reduction in baseline pain accompanied by a VAS pain score less than 50 (mean 38.1). Pain reduction was maintained at 1 month (mean VAS 31.3). The average ODI score at baseline was 55, suggesting significant disability among participants prior to Cortoss treatment. Following treatment, the ODI scores were significantly reduced from these baseline levels (day 8, 47.4; 1 month, 33.6). Further, SF-12 physical and mental component scores at 1 month after treatment increased from baseline by 26% and 11%, respectively; while analgesic use decreased concomitantly, primarily among patients with underlying osteoporosis. A total of 20 adverse events were deemed to be device-related. The most frequent clinically significant adverse events attributed to Cortoss were leakage of Cortoss from within the vertebral body at placement (12%), back pain (7%), and unspecified pain (7%). These results indicate that vertebral augmentation with Cortoss rapidly reduces pain, decreases disability, and improves physical functioning in patients with painful vertebral compression fractures.

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References

  1. 1.

    Bini SA, Gill K, Johnston JO (1995) Giant cell tumor of bone. Curettage and cement reconstruction. Clin Orthop 321:245–250

    PubMed  Google Scholar 

  2. 2.

    Chiras J, Depriester C, Weill A, Sola-Martinez MT, Deramond H (1997) Vertébroplasties percutanées. Technique et indications. J Neuroradiol 24:45–59

    CAS  PubMed  Google Scholar 

  3. 3.

    Cooper C, Atkinson EJ, Jacobsen SJ, O’Fallon WM, Melton LJ III (1993) Population-based study of survival after osteoporotic fractures. Am J Epidemiol 137:1001–1005

    CAS  PubMed  Google Scholar 

  4. 4.

    Cooper C, Atkinson EJ, O’Fallon WM, Melton LJ III (1992) Incidence of clinically diagnosed vertebral fractures: a population-based study in Rochester, Minnesota, 1985–1989. J Bone Miner Res 7:221–227

    CAS  PubMed  Google Scholar 

  5. 5.

    Cortet B, Cotten A, Boutry N, Flipo R-M, Duquesnoy B, Chastanet P, Delcambre B (1999) Percutaneous vertebroplasty in the treatment of osteoporotic vertebral compression fractures: an open prospective study. J Rheumatol 26:2222–2228

    CAS  PubMed  Google Scholar 

  6. 6.

    Cortet B, Cotten A, Deprez X, Deramond H, Lejeune JP, Leclerc X, Chastanet P, Duquesnoy B, Delcambre B (1994) [Value of vertebroplasty combined with surgical decompression in the treatment of aggressive spinal angioma. Apropos of 3 cases]. Rev Rhum Ed Fr 61:16–20

    CAS  PubMed  Google Scholar 

  7. 7.

    Cotten A, Deramond H, Cortet B, Lejeune JP, Leclerc X, Chastanet P, Clarisse J (1996) Preoperative percutaneous injection of methyl methacrylate and N-butyl cyanoacrylate in vertebral hemangiomas. AJNR Am J Neuroradiol 17:137–142

    CAS  PubMed  Google Scholar 

  8. 8.

    Erbe EM, Clineff TD, Gualtieri G (2001) Comparison of a new bisphenol-a-glycidyl dimethacrylate-based cortical bone void filler with polymethyl methacrylate. Eur Spine J 10 [Suppl 2]:S147–152

  9. 9.

    Fairbank JCT, Couper J, Davies JB, O’Brien JP (1980) The Oswestry low back pain disability questionnaire. Physiotherapy 66:271–273

    CAS  PubMed  Google Scholar 

  10. 10.

    Galibert P, Deramond H, Rosat P, Le Gars D (1987) [Preliminary note on the treatment of vertebral angioma by percutaneous acrylic vertebroplasty]. Neurochirurgie 33:166–168

    CAS  PubMed  Google Scholar 

  11. 11.

    Harrington KD (1988) Anterior decompression and stabilization of the spine as a treatment for vertebral collapse and spinal cord compression from metastatic malignancy Clin Orthop (233):177–197

  12. 12.

    Heini PF, Walchli B, Berlemann U (2000) Percutaneous transpedicular vertebroplasty with PMMA: operative technique and early results. A prospective study for the treatment of osteoporotic compression fractures. Eur Spine J 9:445–450

    Article  CAS  PubMed  Google Scholar 

  13. 13.

    Jasper LE, Deramond H, Mathis JM, Belkoff SM (1999) The effect of monomer-to-powder ratio on the material properties of cranioplastic. Bone 25:27S-29S

    Article  CAS  PubMed  Google Scholar 

  14. 14.

    Jensen ME, Evans AJ, Mathis JM, Kallmes DF, Cloft HJ, Dion JE (1997) Percutaneous polymethylmethacrylate vertebroplasty in the treatment of osteoporotic vertebral body compression fractures: technical aspects. AJNR Am J Neuroradiol 18:1897–1904

    CAS  PubMed  Google Scholar 

  15. 15.

    Komiya S, Inoue A (1993) Cementation in the treatment of giant cell tumor of bone. Arch Orthop Trauma Surg 112:51–55

    Article  CAS  PubMed  Google Scholar 

  16. 16.

    Lyles KW, Gold DT, Shipp KM, Pieper CF, Martinez S, Mulhausen PL (1993) Association of osteoporotic vertebral compression fractures with impaired functional status. Am J Med 94:595–601

    Article  CAS  PubMed  Google Scholar 

  17. 17.

    Nicola N, Lins E (1987) Vertebral hemangioma: retrograde embolization-stabilization with methyl methacrylate. Surg Neurol 27:481–486

    Article  CAS  PubMed  Google Scholar 

  18. 18.

    Persson BM, Ekelund L, Lovdahl R, Gunterberg B (1984) Favourable results of acrylic cementation for giant cell tumors. Acta Orthop Scand 55:209–214

    CAS  PubMed  Google Scholar 

  19. 19.

    Sabokbar A, Fujikawa Y, Murray DW, Athanasou NA (1997) Radio-opaque agents in bone cement increase bone resorption. J Bone Joint Surg Br 79:129–134

    Article  CAS  PubMed  Google Scholar 

  20. 20.

    Silverman SL (1992) The clinical consequences of vertebral compression fracture. Bone 13 [Suppl 2]:S27–31

    Google Scholar 

  21. 21.

    Silverman SL, Minshall ME, Shen W, Harper KD, Xie S on behalf of the Health-Related Quality of Life Subgroup of the Multiple Outcomes of Raloxifene Evaluation Study (2001) The relationship of health-related quality of life to prevalent and incident vertebral fractures in postmenopausal women with osteoporosis. Arthritis Rheum 44:2611–2619

    Article  CAS  PubMed  Google Scholar 

  22. 22.

    Sundaresan N, Galicich JH, Lane JM, Bains MS, McCormack P (1985) Treatment of neoplastic epidural cord compression by vertebral body resection and stabilization. J Neurosurg 63:676–684

    CAS  PubMed  Google Scholar 

  23. 23.

    Ware J Jr, Kosinski M, Keller SD (1996) A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 34:220–233

    PubMed  Google Scholar 

  24. 24.

    Weill A, Chiras J, Simon JM, Rose M, Sola-Martinez T, Enkaoua E (1996) Spinal metastases: indications for and results of percutaneous injection of acrylic surgical cement. Radiology 199:241–247

    Google Scholar 

  25. 25.

    Zoarski GH, Snow P, Olan WJ, Stallmeyer MJ, Dick BW, Hebel JR, De Deyne M (2002) Percutaneous vertebroplasty for osteoporotic compression fractures: quantitative prospective evaluation of long-term outcomes. J Vasc Interv Radiol 13:139–148

    PubMed  Google Scholar 

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Acknowledgements

The authors wish to thank Dr Ludo Haazen and Sylvie Hermans as well as the clinical research assistants from Orthovita, and Ms Marie-Laure Jolly-Loubès from the Institut Bergonie, for their invaluable assistance in preparing this manuscript.

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Correspondence to Jean Palussière.

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This work was funded by Orthovita Europe, Leuven, Belgium

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Palussière, J., Berge, J., Gangi, A. et al. Clinical results of an open prospective study of a bis-GMA composite in percutaneous vertebral augmentation. Eur Spine J 14, 982–991 (2005). https://doi.org/10.1007/s00586-003-0664-2

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Keywords

  • Vertebral fracture repair
  • Percutaneous vertebral augmentation
  • Bis-GMA
  • Bone substitutes
  • Methacrylates