Advertisement

European Spine Journal

, Volume 23, Issue 6, pp 1361–1368 | Cite as

Demineralization after balloon kyphoplasty with calcium phosphate cement: a histological evaluation in ten patients

  • Rainer Gumpert
  • Koppany Bodo
  • Ekkehard Spuller
  • Thomas Poglitsch
  • Ronny Bindl
  • Anita Ignatius
  • Paul PuchweinEmail author
Original Article

Abstract

Purpose

Balloon kyphoplasty (BKP) with calcium phosphate cement (CPC) is increasingly being used for spinal surgery in younger patients. In routinely performed follow-up CT scans we observed considerable areas of demineralization in CPC processed vertebrae in several patients. To rule out infections or inflammations histological examinations were planned for these patients.

Methods

Ten patients (23–54 years; six men) with significant demineralization areas in CT scans after CPC balloon kyphoplasty were selected. Punch biopsies from these areas were taken in local anesthesia using a biopsy needle. One half of the specimen was decalcified and embedded in paraffin, and sections were examined histologically using hematoxylin and eosin, Van Gieson, and trichrome staining. The second half of the specimen was cast directly in methyl methacrylate and sections were examined by Paragon and von Kossa/Safranin staining. Stained slides were viewed under light microscopy.

Results

Bone-punch specimens were taken at 17.5 months (mean) after BKP with CPC. In most cases, the cement was well surrounded by newly formed lamellar bone with very tight connections between the cement and new bone. Unmineralized areas were observed sporadically at the cement surface and adjacent to the implant. There were no pronounced signs of inflammation or osteolysis of adjacent bone. No complications were observed during or following patients’ biopsy procedures.

Conclusions

CPC demonstrated good biocompatibility and osseointegration in clinical use, with no evidence of inflammation or osteonecrosis. Demineralized areas in CT scans could be a result of remodeling of the cancellous bone in vertebral bodies.

Keywords

Balloon kyphoplasty Biocompatibility Bone biopsy Calcium phosphate cement Histology Osseointegration Vertebra 

Notes

Acknowledgments

The authors would like to thank Professor Seggl for providing approval to perform the study. All authors would like to thank Medtronic for their support for the study. RG would also like to thank N. Stockenhuber who introduced the BKP with CPC procedure to his hospital and provided assistance based on his extensive experience. The authors would also like to thank Dr. Richard Barry (Quintiles Medical Communications) for medical writing assistance, which was funded by Medtronic.

Conflict of interest

The authors declare that they have no conflict of interest.

References

  1. 1.
    Grafe IA, Baier M, Noldge G et al (2008) Calcium-phosphate and polymethylmethacrylate cement in long-term outcome after kyphoplasty of painful osteoporotic vertebral fractures. Spine (Phila Pa 1976) 33:1284–1290CrossRefGoogle Scholar
  2. 2.
    McArthur N, Kasperk C, Baier M et al (2009) 1,150 kyphoplasties over 7 years: indications, techniques, and intraoperative complications. Orthopedics 32:90PubMedGoogle Scholar
  3. 3.
    Wardlaw D, Cummings SR, Van Meirhaeghe J et al (2009) Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet 373:1016–1024PubMedCrossRefGoogle Scholar
  4. 4.
    Garfin SR, Buckley RA, Ledlie J (2006) Balloon kyphoplasty for symptomatic vertebral body compression fractures results in rapid, significant, and sustained improvements in back pain, function, and quality of life for elderly patients. Spine (Phila Pa 1976) 31:2213–2220CrossRefGoogle Scholar
  5. 5.
    Oner FC, Dhert WJA, Verlaan JJ (2005) Less invasive anterior column reconstruction in thoracolumbar fractures. Injury 36:S82–S89CrossRefGoogle Scholar
  6. 6.
    Verlaan JJ, Dhert WJ, Verbout AJ et al (2005) Balloon vertebroplasty in combination with pedicle screw instrumentation: a novel technique to treat thoracic and lumbar burst fractures. Spine (Phila Pa 1976) 30:E73–E79CrossRefGoogle Scholar
  7. 7.
    Verlaan JJ, Van De Kraats EB, Oner FC et al (2005) The reduction of endplate fractures during balloon vertebroplasty: a detailed radiological analysis of the treatment of burst fractures using pedicle screws, balloon vertebroplasty, and calcium phosphate cement. Spine (Phila Pa 1976) 30:1840–1845CrossRefGoogle Scholar
  8. 8.
    Verlaan JJ, Van De Kraats EB, Oner FC et al (2005) Bone displacement and the role of longitudinal ligaments during balloon vertebroplasty in traumatic thoracolumbar fractures. Spine (Phila Pa 1976) 30:1832–1839CrossRefGoogle Scholar
  9. 9.
    Verlaan JJ, van Helden WH, Oner FC et al (2002) Balloon vertebroplasty with calcium phosphate cement augmentation for direct restoration of traumatic thoracolumbar vertebral fractures. Spine (Phila Pa 1976) 27:543–548CrossRefGoogle Scholar
  10. 10.
    Lieberman IH, Re: Verlaan JJ, Van Helden WH, Oner FC et al (2002) Balloon vertebroplasty with calcium phosphate cement for direct restoration of traumatic thoraco-lumbar vertebral fractures. Spine 27:543–548 Spine (Phila Pa 1976) 2002;27:2300–2301CrossRefGoogle Scholar
  11. 11.
    Voggenreiter G (2005) Balloon kyphoplasty is effective in deformity correction of osteoporotic vertebral compression fractures. Spine (Phila Pa 1976) 30:2806–2812CrossRefGoogle Scholar
  12. 12.
    Korovessis P, Hadjipavlou A, Repantis T (2008) Minimal invasive short posterior instrumentation plus balloon kyphoplasty with calcium phosphate for burst and severe compression lumbar fractures. Spine 33:658–667PubMedCrossRefGoogle Scholar
  13. 13.
    Korovessis P, Repantis T, Petsinis G et al (2008) Direct reduction of thoracolumbar burst fractures by means of balloon kyphoplasty with calcium phosphate and stabilization with pedicle-screw instrumentation and fusion. Spine 33:E100–E108PubMedCrossRefGoogle Scholar
  14. 14.
    Maestretti G, Cremer C, Otten P et al (2007) Prospective study of standalone balloon kyphoplasty with calcium phosphate cement augmentation in traumatic fractures. Eur Spine J 16:601–610PubMedCentralPubMedCrossRefGoogle Scholar
  15. 15.
    Marco RA, Kushwaha VP (2009) Thoracolumbar burst fractures treated with posterior decompression and pedicle screw instrumentation supplemented with balloon-assisted vertebroplasty and calcium phosphate reconstruction. J Bone Jt Surg Am 91:20–28CrossRefGoogle Scholar
  16. 16.
    Marco RA, Meyer BC, Kushwaha VP (2010) Thoracolumbar burst fractures treated with posterior decompression and pedicle screw instrumentation supplemented with balloon-assisted vertebroplasty and calcium phosphate reconstruction. Surgical technique. J Bone Jt Surg Am 92 Suppl 1 Pt 1:67–76Google Scholar
  17. 17.
    Oner FC, Verlaan JJ, Verbout AJ et al (2006) Cement augmentation techniques in traumatic thoracolumbar spine fractures. Spine (Phila Pa 1976) 31:S89–S95CrossRefGoogle Scholar
  18. 18.
    Schmelzer-Schmied N, Cartens C, Meeder PJ et al (2009) Comparison of kyphoplasty with use of a calcium phosphate cement and non-operative therapy in patients with traumatic non-osteoporotic vertebral fractures. Eur Spine J 18:624–629PubMedCentralPubMedCrossRefGoogle Scholar
  19. 19.
    Grass R, Biewener A, Dickopf A et al (2006) [Percutaneous dorsal versus open instrumentation for fractures of the thoracolumbar border. A comparative, prospective study]. Unfallchirurg 109:297–305PubMedCrossRefGoogle Scholar
  20. 20.
    Yi L, Jingping B, Gele J et al (2006) Operative versus non-operative treatment for thoracolumbar burst fractures without neurological deficit. Cochrane Database Syst Rev CD005079Google Scholar
  21. 21.
    Hong SJ, Park YK, Kim JH et al (2006) The biomechanical evaluation of calcium phosphate cements for use in vertebroplasty. J Neurosurg Spine 4:154–159PubMedCrossRefGoogle Scholar
  22. 22.
    Khanna AJ, Lee S, Villarraga M et al (2008) Biomechanical evaluation of kyphoplasty with calcium phosphate cement in a 2-functional spinal unit vertebral compression fracture model. Spine J 8:770–777PubMedCrossRefGoogle Scholar
  23. 23.
    Lim TH, Brebach GT, Renner SM et al (2002) Biomechanical evaluation of an injectable calcium phosphate cement for vertebroplasty. Spine (Phila Pa 1976) 27:1297–1302CrossRefGoogle Scholar
  24. 24.
    Nouda S, Tomita S, Kin A et al (2009) Adjacent vertebral body fracture following vertebroplasty with polymethylmethacrylate or calcium phosphate cement: biomechanical evaluation of the cadaveric spine. Spine (Phila Pa 1976) 34:2613–2618CrossRefGoogle Scholar
  25. 25.
    Rotter R, Pflugmacher R, Kandziora F et al (2007) Biomechanical in vitro testing of human osteoporotic lumbar vertebrae following prophylactic kyphoplasty with different candidate materials. Spine (Phila Pa 1976) 32:1400–1405CrossRefGoogle Scholar
  26. 26.
    Tomita S, Molloy S, Jasper LE et al (2004) Biomechanical comparison of kyphoplasty with different bone cements. Spine (Phila Pa 1976) 29:1203–1207CrossRefGoogle Scholar
  27. 27.
    Wilke HJ, Mehnert U, Claes LE et al (2006) Biomechanical evaluation of vertebroplasty and kyphoplasty with polymethyl methacrylate or calcium phosphate cement under cyclic loading. Spine (Phila Pa 1976) 31:2934–2941CrossRefGoogle Scholar
  28. 28.
    Libicher M, Vetter M, Wolf I et al (2005) CT volumetry of intravertebral cement after kyphoplasty. Comparison of polymethylmethacrylate and calcium phosphate in a 12-month follow-up. Eur Radiol 15:1544–1549PubMedCrossRefGoogle Scholar
  29. 29.
    Schildhauer TA, Bauer TW, Josten C et al (2000) Open reduction and augmentation of internal fixation with an injectable skeletal cement for the treatment of complex calcaneal fractures. J Orthop Trauma 14:309–317PubMedCrossRefGoogle Scholar
  30. 30.
    Verlaan JJ, Oner FC, Slootweg PJ et al (2004) Histologic changes after vertebroplasty. J Bone Jt Surg Am 86-A:1230–1238Google Scholar
  31. 31.
    Blattert TR, Jestaedt L, Weckbach A (2009) Suitability of a calcium phosphate cement in osteoporotic vertebral body fracture augmentation: a controlled, randomized, clinical trial of balloon kyphoplasty comparing calcium phosphate versus polymethylmethacrylate. Spine (Phila Pa 1976) 34:108–114CrossRefGoogle Scholar
  32. 32.
    Heini PF, Berlemann U (2001) Bone substitutes in vertebroplasty. Eur Spine J 10(Suppl 2):S205–S213PubMedCentralPubMedGoogle Scholar
  33. 33.
    Korovessis PG (2009) Suitability of calcium phosphate cement (compared with polymethyl-methacrylate [PMMA]) in osteoporotic bisegmental body fracture augmentation. Spine (Phila Pa 1976) 34:2110–2111CrossRefGoogle Scholar
  34. 34.
    Larsson S, Bauer TW (2002) Use of injectable calcium phosphate cement for fracture fixation: a review. Clin Orthop Relat Res (395):23–32Google Scholar
  35. 35.
    O’Hara RM, Dunne NJ, Orr JF et al (2010) Optimisation of the mechanical and handling properties of an injectable calcium phosphate cement. J Mater Sci Mater Med 21:2299–2305PubMedCrossRefGoogle Scholar
  36. 36.
    Bai B, Yin Z, Xu Q et al (2009) Histological changes of an injectable rhBMP-2/calcium phosphate cement in vertebroplasty of rhesus monkey. Spine (Phila Pa 1976) 34:1887–1892CrossRefGoogle Scholar
  37. 37.
    Goto K, Shinzato S, Fujibayashi S et al (2006) The biocompatibility and osteoconductivity of a cement containing beta-TCP for use in vertebroplasty. J Biomed Mater Res A 78:629–637PubMedCrossRefGoogle Scholar
  38. 38.
    Kobayashi N, Ong K, Villarraga M et al (2007) Histological and mechanical evaluation of self-setting calcium phosphate cements in a sheep vertebral bone void model. J Biomed Mater Res A 81:838–846PubMedCrossRefGoogle Scholar
  39. 39.
    Turner TM, Urban RM, Singh K et al (2008) Vertebroplasty comparing injectable calcium phosphate cement compared with polymethylmethacrylate in a unique canine vertebral body large defect model. Spine J 8:482–487PubMedCrossRefGoogle Scholar
  40. 40.
    Frankenburg EP, Goldstein SA, Bauer TW et al (1998) Biomechanical and histological evaluation of a calcium phosphate cement. J Bone Jt Surg Am 80:1112–1124Google Scholar
  41. 41.
    Spies C, Schnurer S, Gotterbarm T et al (2008) Animal study of the bone substitute material Ostim within osseous defects in Gottinger minipigs. Z Orthop Unfall 146:64–69PubMedGoogle Scholar
  42. 42.
    Heo DH, Cho SM, Cho YJ et al (2010) Heterotopic ossifications after vertebroplasty using calcium phosphate in osteoporotic vertebral compression fractures: report of 2 cases. World Neurosurg 73:207–209PubMedCrossRefGoogle Scholar
  43. 43.
    Heo HD, Cho YJ, Sheen SH et al (2009) Morphological changes of injected calcium phosphate cement in osteoporotic compressed vertebral bodies. Osteoporos Int 20:2063–2070PubMedCentralPubMedCrossRefGoogle Scholar
  44. 44.
    Nakano M, Hirano N, Ishihara H et al (2006) Calcium phosphate cement-based vertebroplasty compared with conservative treatment for osteoporotic compression fractures: a matched case-control study. J Neurosurg Spine 4:110–117PubMedCrossRefGoogle Scholar
  45. 45.
    Kobayashi H, Fujishiro T, Belkoff SM et al. (2009) Long-term evaluation of a calcium phosphate bone cement with carboxymethyl cellulose in a vertebral defect model. J Biomed Mater Res A 88:880–888PubMedCrossRefGoogle Scholar
  46. 46.
    de Klerk LW, Fontijne WP, Stijnen T et al (1998) Spontaneous remodeling of the spinal canal after conservative management of thoracolumbar burst fractures. Spine (Phila Pa 1976) 23:1057–1060CrossRefGoogle Scholar
  47. 47.
    Ha KI, Han SH, Chung M et al (1996) A clinical study of the natural remodeling of burst fractures of the lumbar spine. Clin Orthop Relat Res 210–214Google Scholar
  48. 48.
    Hashimoto K, Yasui N, Yamagishi M et al (1989) Intravertebral vacuum cleft in the fifth lumbar vertebra. Spine (Phila Pa 1976) 14:351–354CrossRefGoogle Scholar
  49. 49.
    Jung JY, Lee MH, Ahn JM (2006) Leakage of polymethylmethacrylate in percutaneous vertebroplasty: comparison of osteoporotic vertebral compression fractures with and without an intravertebral vacuum cleft. J Comput Assist Tomogr 30:501–506PubMedCrossRefGoogle Scholar
  50. 50.
    Libicher M, Appelt A, Berger I et al (2007) The intravertebral vacuum phenomen as specific sign of osteonecrosis in vertebral compression fractures: results from a radiological and histological study. Eur Radiol 17:2248–2252PubMedCrossRefGoogle Scholar
  51. 51.
    Linn J, Birkenmaier C, Hoffmann RT et al (2009) The intravertebral cleft in acute osteoporotic fractures: fluid in magnetic resonance imaging-vacuum in computed tomography? Spine (Phila Pa 1976) 34:E88–E93CrossRefGoogle Scholar
  52. 52.
    Osterhouse MD, Kettner NW (2002) Delayed posttraumatic vertebral collapse with intravertebral vacuum cleft. J Manip Physiol Ther 25:270–275CrossRefGoogle Scholar
  53. 53.
    Sarli M, Perez Manghi FC, Gallo R et al (2005) The vacuum cleft sign: an uncommon radiological sign. Osteoporos Int 16:1210–1214PubMedCrossRefGoogle Scholar
  54. 54.
    Theodorou DJ (2001) The intravertebral vacuum cleft sign. Radiology 221:787–788PubMedCrossRefGoogle Scholar
  55. 55.
    Togawa D, Bauer TW, Lieberman IH et al (2003) Histologic evaluation of human vertebral bodies after vertebral augmentation with polymethyl methacrylate. Spine (Phila Pa 1976) 28:1521–1527Google Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2014

Authors and Affiliations

  • Rainer Gumpert
    • 1
  • Koppany Bodo
    • 2
  • Ekkehard Spuller
    • 2
    • 4
  • Thomas Poglitsch
    • 1
  • Ronny Bindl
    • 3
  • Anita Ignatius
    • 3
  • Paul Puchwein
    • 1
    Email author
  1. 1.Department of TraumatologyMedical University Graz (MUG)GrazAustria
  2. 2.Institute of PathologyMedical University of GrazGrazAustria
  3. 3.Institute for Orthopaedic Research and BiomechanicsUniversity of UlmUlmGermany
  4. 4.Institute of CytologyUniversity Hospital of GrazGrazAustria

Personalised recommendations