Percutaneous Vertebroplasty and Balloon Kyphoplasty in Treating Painful Osteoporotic Vertebral Compression Fractures

This document was published more than 2 years ago. The nature of the evidence may have changed.

Summary and conclusions

Percutaneous vertebroplasty and balloon kyphoplasty are methods that may be used to treat severe back pain resulting from vertebral compression fractures in patients not receiving adequate pain relief from conventional, nonsurgical interventions.

SBU’s appraisal of the evidence

  • The scientific evidence is insufficient to determine if percutaneous vertebroplasty or balloon kypho­plasty yield better outcomes than nonsurgical strategies or placebo1 in treating symptomatic vertebral compression fractures due to osteoporosis.
  • Cement leakage is common with both methods. Al­­though it usually causes no symptoms, the clin­ic­­al significance of such leakage is not fully investigated.
  • The scientific evidence is insufficient to determine the cost-effectiveness of percutaneous vertebroplasty and balloon kyphoplasty.
  • Randomised and blinded trials should be conducted, but such trials are associated with substantial methodological problems. Long-term evaluation of the methods’ effects and risks would require systematic follow-up, e.g. via a national quality registry.

Treatment methods and target group

Vertebral compression refers to the compression and subse­quent reduction in height of a vertebra. Most vertebral compressions, approximately 15 000 annually in Sweden, are attributed to bone fragility caused by osteoporosis. Other causes include multiple myeloma or cancers that can metastasise to vertebrae. This report, however, limits the discussion to vertebral fractures resulting from osteoporosis.

Vertebral compression is associated with various degrees of pain. The pain in approximately 25 percent of cases is so severe that patients must be hospitalised, sometimes for long periods. Treatment usually involves a combin­ation of pain-relieving drugs, possibly the use of a corset, gradual mobilisation, and occasionally physiotherapy. Scientific data describing the natural course of vertebral compression fractures are largely lacking. A Swedish study recently reported that two thirds of those seeking care due to acute vertebral compression fractures con­tinue to experience pain one year after the injury.

In selected patients with severe and functionally disabling pain, a treatment option that has been available for several years involves injecting cement to stabilise the fracture, i.e. percutaneous vertebroplasty. This is a minimally invasive procedure performed under radiological monitoring. A variant of this method is balloon kyphoplasty.

In percutaneous vertebroplasty, cement is injected into a fractured vertebra for the purpose of strengthening and stabilising the vertebral body, thereby aiming for rapid pain relief. In balloon kyphoplasty, one or two balloons are inflated in a compressed vertebra in an attempt to regain height and reduce deformity. The balloons are then deflated and cement is injected into the created cavity/cavities to stabilise the damaged vertebra.

It is difficult to estimate how many patients might be candidates for percutaneous vertebroplasty or balloon kyphoplasty, but a rough estimate would be 1 000 to 1 500 patients annually in Sweden. The methods could be particularly important as treatment options for patients bedridden due to severe pain. These patients have a higher risk of complications, primarily additional fractures resulting from decalcification of the skeleton following immobilisation.

Primary questions

  • Are percutaneous vertebroplasty and balloon kypho­plasty safe and effective methods of treating severe back pain caused by osteoporotic vertebral compression when conventional, nonsurgical options do not provide adequate pain relief?
  • What do the treatments cost? Are they cost-effective?

This assessment does not aim to evaluate the effects of these methods on spinal deformity after vertebral compression, nor does it address patients with symptoms involving compression of neural structures.

Patient benefit

Percutaneous vertebroplasty

  • The scientific evidence is insufficient* to determine if percutaneous vertebroplasty provides better pain relief, functional capacity, or quality of life than nonsurgical options in treating vertebral compression fractures.
  • Limited scientific evidence suggests that the effects of percutaneous vertebroplasty and placebo are similar (Evidence grade 3*).
  • Strong scientific evidence shows that cement leakage occurs in conjunction with percutaneous vertebroplasty (Evidence grade 1*).
  • The evidence is insufficient* to appraise the long-term effects, risks, and side effects of the method.

Three randomised, controlled, multicentre trials of me­­dium quality comprise the scientific evidence.

In a study comparing percutaneous vertebroplasty and nonsurgical treatment, patients that had been treated with percutaneous vertebroplasty reported higher pain relief at follow-up after 1 month and 1 year respectively. Quality of life and functional capacity improved immedi­ately after the procedure.

Two studies randomised patients to either percutaneous vertebroplasty or placebo (sham operation) where the sham procedure was similar to percutaneous vertebroplasty, but without injection of cement in the vertebra. The studies revealed no differences between the groups as measured by the effects on pain intensity or functional capacity at follow-up.

Balloon kyphoplasty

  • The scientific evidence is insufficient* to determine if balloon kyphoplasty provides better pain relief, functional capacity, or quality of life than nonsurgical options in treating vertebral compression.
  • Strong scientific evidence shows that cement leak­age occurs in conjunction with balloon kyphoplasty ­(Evidence grade 1*).
  • The evidence is insufficient* to appraise the long-term effects, risks, and side effects of the method.

One randomised controlled trial of medium quality compared balloon kyphoplasty and nonsurgical treat­ment of vertebral compression due to osteoporosis. In the short term (up to 1 year) balloon kyphoplasty was reported to offer somewhat better pain relief, increased quality of life and functional capacity.

Complications and adverse events

Serious complications are unusual, although cement might leak outside of the vertebral body. Cement that leaks into veins surrounding the vertebral body can be transported and result in pulmonary cement emboli. Al­­though most of these cause no symptoms, some serious cases, including deaths, have been reported.

Economic aspects

  • The scientific evidence is insufficient* as regards the cost-effectiveness of percutaneous vertebroplasty and balloon kyphoplasty.

Three studies were identified that addressed the costs and cost-effectiveness of percutaneous vertebroplasty or balloon kyphoplasty in treating back pain due to vertebral compression fractures. Two are empirical studies and ad­­dress percutaneous vertebroplasty. The study address­ing balloon kyphoplasty is a model analysis.

All costs are calculated in SEK2. The cost of percutaneous vertebroplasty and associated treatment (up to 1 year) is estimated to range between SEK 64 000 and 87 000. The cost of nonsurgical treatment during the same period is estimated to range between SEK 60 000 and 82 000.

In a Swedish context, the balloon kyphoplasty procedure itself is estimated to cost approximately SEK 70 000, which is higher than the cost of percutaneous vertebroplasty.

Footnotes

1 A sham operation involving a procedure similar to percutaneous vertebroplasty, but without injecting cement into the vertebra.

2 Exchange rates May 24, 2011: USD 1 = SEK 6.37; EUR 1 = SEK 8.94.

* Criteria for evidence grading SBU’s conclusions
Evidence grade 1 – Strong scientific evidence. The conclusion is corroborated by at least two independent studies with high qual­ity, or a good systematic overview.
Evidence grade 2 – Moderately strong scientific evidence. The conclusion is corroborated by one study with high quality, and at least two studies with medium quality.
Evidence grade 3 – Limited scientific evidence. The conclusion is corroborated by at least two studies with medium quality.
Insufficient scientific evidence – No conclusions can be drawn when there are not any studies that meet the criteria for quality.
Contradictory scientific evidence – No conclusions can be drawn when there are studies with the same quality whose findings contradict each other.

SBU Alert is a service provided by SBU in collaboration with the Medical Products Agency, the National Board of Health and Welfare, and the Swedish Association of Local Authorities and Regions.

References

  1. Ross PD. Clinical consequences of vertebral fractures. Am J Med 1997;103(2A):30S-42S; discussion 42S-43S.
  2. Kanis JA, Johnell O, Oden A, Sembo I, Redlund-Johnell I, Dawson A, et al. Long-term risk of osteoporotic fracture in Malmö. Osteoporos Int 2000;11(8):669-74.
  3. Incidence of vertebral fracture in Europe: results from the European Prospective Osteoporosis Study (EPOS). J Bone Miner Res 2002;17(4):716-24.
  4. Johnell O, Oden A, Caulin F, Kanis JA. Acute and long-term increase in fracture risk after hospitalization for vertebral fracture. Osteoporos Int 2001;12(3):207-14.
  5. Suzuki N, Ogikubo O, Hansson T. The course of the acute vertebral body fragility fracture: its effect on pain, disability and quality of life during 12 months. Eur Spine J 2008;17(10):1380-90.
  6. Cooper C, Atkinson EJ, O’Fallon WM, Melton LJ 3rd. Incidence of clinically diagnosed vertebral fractures: a population-based study in Rochester, Minnesota, 1985-1989. J Bone Miner Res 1992;7(2):221-7.
  7. Burge R, Puleo E, Gehlbach S, Worley D, Klar J. Inpatient hospital and post-acute care for vertebral fractures in women. Value Health 2002;5(4):301-11.
  8. Coupland C, Wood D, Cooper C. Physical inactivity is an independent risk factor for hip fracture in the elderly. J Epidemiol Community Health 1993;47(6):441-3.
  9. Galibert P, Deramond H, Rosat P, Le Gars D. [Preliminary note on the treatment of vertebral angioma by percutaneous acrylic vertebroplasty]. Neurochirurgie 1987;33(2):166-8.
  10. Garfin SR, Yuan HA, Reiley MA. New technologies in spine: kyphoplasty and vertebroplasty for the treatment of painful osteoporotic compression fractures. Spine 2001;26(14):1511-5.
  11. Lieberman IH, Dudeney S, Reinhardt MK, Bell G. Initial outcome and efficacy of ”kyphoplasty” in the treatment of painful osteoporotic vertebral compression fractures. Spine 2001;26(14):1631-8.
  12. Diel P, Merky D, Röder C, Popp A, Perler M, Heini PF. Safety and efficacy of vertebroplasty: Early results of a prospective one-year case series of osteoporosis patients in an academic high-volume center. Indian J Orthop 2009;43(3):228-33.
  13. Hiwatashi A, Yoshiura T, Yamashita K, Kamano H, Dashjamts T, Honda H. Morphologic change in vertebral body after percutaneous vertebroplasty: follow-up with MDCT. AJR Am J Roentgenol 2010;195(3):W207-12.
  14. Buchbinder R, Osborne RH, Ebeling PR, Wark JD, Mitchell P, Wriedt C, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med 2009;361(6):557-68.
  15. Kallmes DF, Comstock BA, Heagerty PJ, Turner JA, Wilson DJ, Diamond TH, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med 2009;361(6):569-79.
  16. Klazen CA, Lohle PN, de Vries J, Jansen FH, Tielbeek AV, Blonk MC, et al. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet 2010;376(9746):1085-92.
  17. SBU. Perkutan vertebroplastik vid svår ryggsmärta pga kotkompression. Stockholm: Statens beredning för medicinsk utvärdering (SBU); 2007. SBU Alert-rapport nr 2007-02. ISSN 1652-7151. http://www.sbu.se
  18. Klazen CA, Venmans A, de Vries J, van Rooij WJ, Jansen FH, Blonk MC, et al. Percutaneous vertebroplasty is not a risk factor for new osteoporotic compression fractures: results from VERTOS II. AJNR Am J Neuroradiol 2010;31(8):1447-50.
  19. Lee MJ, Dumonski M, Cahill P, Stanley T, Park D, Singh K. Percutaneous treatment of vertebral compression fractures: a meta-analysis of complications. Spine (Phila Pa 1976) 2009;34(11):1228-32.
  20. Venmans A, Klazen CA, Lohle PN, van Rooij WJ, Verhaar HJ, de Vries J, et al. Percutaneous vertebroplasty and pulmonary cement embolism: results from VERTOS II. AJNR Am J Neuroradiol 2010;31(8):1451-3.
  21. Venmans A, Klazen CA, van Rooij WJ, de Vries J, Mali WP, Lohle PN. Postprocedural CT for perivertebral cement leakage in percutaneous vertebroplasty is not necessary – results from VERTOS II. Neuroradiology 2011;53(1):19-22.
  22. Bachmeyer C, Wislez M, Khalil A. [Multiple pulmonary embolism of cement after vertebroplasty]. Presse Med 2009;39(3):406-7.
  23. Chen HL, Wong CS, Ho ST, Chang FL, Hsu CH, Wu CT. A lethal pulmonary embolism during percutaneous vertebroplasty. Anesth Analg 2002;95(4):1060-2, table of contents.
  24. Wardlaw D, Cummings SR, Van Meirhaeghe J, Bastian L, Tillman JB, Ranstam J, et al. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet 2009;373(9668):1016-24.
  25. Acke Ohlin and Peter Fritzell, personal communication.
  26. Burström K, Johannesson M, Diderichsen F. Swedish population health-related quality of life results using the EQ-5D. Qual Life Res 2001;10(7):621-35.
  27. Liu JT, Liao WJ, Tan WC, Lee JK, Liu CH, Chen YH, et al. Balloon kyphoplasty versus vertebroplasty for treatment of osteoporotic vertebral compression fracture: a prospective, comparative, and randomized clinical study. Osteoporos Int 2009;21(2):359-64.
  28. De Negri P, Tirri T, Paternoster G, Modano P. Treatment of painful osteoporotic or traumatic vertebral compression fractures by percutaneous vertebral augmentation procedures: a nonrandomized comparison between vertebroplasty and kyphoplasty. Clin J Pain 2007;23(5):425-30.
  29. Lovi A, Teli M, Ortolina A, Costa F, Fornari M, Brayda-Bruno M. Vertebroplasty and kyphoplasty: complementary techniques for the treatment of painful osteoporotic vertebral compression fractures. A prospective non-randomised study on 154 patients. Eur Spine J 2009;18 Suppl 1:95-101.
  30. Pflugmacher R, Kandziora F, Schröder R, Schleicher P, Scholz M, Schnake K, et al. [Vertebroplasty and kyphoplasty in osteoporotic fractures of vertebral bodies – a prospective 1-year follow-up analysis]. Rofo 2005;177(12):1670-6.
  31. Röllinghoff M, Siewe J, Zarghooni K, Sobottke R, Alparslan Y, Eysel P, et al. Effectiveness, security and height restoration on fresh compression fractures – a comparative prospective study of vertebroplasty and kyphoplasty. Minim Invasive Neurosurg 2009;52(5-6):233-7.
  32. Santiago FR, Abela AP, Alvarez LG, Osuna RM, García Mdel M. Pain and functional outcome after vertebroplasty and kypho­plasty. A comparative study. Eur J Radiol 2010;75(2):e108-13.
  33. Schofer MD, Efe T, Timmesfeld N, Kortmann HR, Quante M. Comparison of kyphoplasty and vertebroplasty in the treatment of fresh vertebral compression fractures. Arch Orthop Trauma Surg 2009;129(10):1391-9.
  34. Eck JC, Nachtigall D, Humphreys SC, Hodges SD. Comparison of vertebroplasty and balloon kyphoplasty for treatment of vertebral compression fractures: a meta-analysis of the literature. Spine J 2008;8(3):488-97.
  35. Edidin AA, Ong K, Lau E, Kurtz SM. Mortality risk for operated and non-operated vertebral fracture patients in the Medicare population. American Academy of Orthopaedic Surgeons (AAOS). 2009 Annual Meeting Podium Presentations, Las Vegas, USA, February 26, 2009.
  36. von Wrangel A, Cederblad A, Rodriguez-Catarino M. Fluoroscopically guided percutaneous vertebroplasty: assessment of radiation doses and implementation of procedural routines to reduce operator exposure. Acta Radiol 2009;50(5):490-6.
  37. Miriam Rodriguez-Catarino, personal communication.
  38. Peter Fritzell, personal communication.
  39. Rousing R, Hansen KL, Andersen MO, Jespersen SM, Thomsen K, Lauritsen JM. Twelve-months follow-up in forty-nine patients with acute/semiacute osteoporotic vertebral fractures treated conservatively or with percutaneous vertebroplasty: a clinical randomized study. Spine (Phila Pa 1976) 2010;35(5):478-82.
  40. Rousing R, Lauritsen J, Thomsen K, Andersen M, Jespersen MS, Kidholm K, et al. Perkutan vertebroplastik som behandling af smertefulde osteoporotiske rygfrakturer – en medicinsk teknologivurdering. København: Sundhedsstyrelsen, Monitorering & Medicinsk Teknologivurdering, 2010. Medicinsk Teknologivurdering – puljeprojekter 2010;10(1).
  41. Ström O, Leonard C, Marsh D, Cooper C. Cost-effectiveness of balloon kyphoplasty in patients with symptomatic vertebral compression fractures in a UK setting. Osteoporos Int 2010;21(9):1599-608.
  42. Rodriguez-Catarino M. [Percutaneous vertebroplasty – a new method for alleviation of back pain]. Lakartidningen 2002;99(9):882-90.
  43. Grohs JG. Minimal-invasive Stabilisierung osteoporotischer Wirbelkörpereinbrüche. Journal für Mineralstoffwechsel 2003;10(4):7-12.
Download summary

SBU Assessment presents a comprehensive, systematic assessment of available scientific evidence. The certainty of the evidence for each finding is systematically reviewed and graded. Full assessments include economic, social, and ethical impact analyses.

SBU assessments are performed by a team of leading professional practitioners and academics, patient/user representatives and SBU staff. Prior to approval and publication, assessments are reviewed by independent experts, SBU’s Scientific Advisory Committees and Board of Directors.

Published: 3/30/2011
Contact SBU: registrator@sbu.se
Report no: 2011-02
http://www.sbu.se/201102e
Page updated