ISASS Policy Statement – Vertebral Augmentation

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ISASS Policy Statement – Vertebral Augmentation

It is estimated that over 1.4 million people will develop vertebral compression fractures every year (Johnell & Kanis 2006).  Many will be clinically insignificant or heal with non-operative treatment.  A large group will have persistent pain, kypholic deformity, weight loss, depression and a reduced quality of life.  (Old & Calvert 2004; Borgstrom et al. 2006; Suzuki et al. 2008).

Open surgical intervention is used when there is severe deformity, instability, or neurologic compromise. Vertebral augmentation such as Vertebroplasty (VP) and balloon kyphoplasty (BKP) are minimally invasive techniques used to treat painful vertebral compression fractures.  There is good evidence that these techniques can provide immediate and lasting pain relief (Berlemann et al. 2004; Grafe et al. 2005; Groh et al. 2005; Alvarez et al. 2006; DeNegri et al. 2007; Lovi et al. 2009; Schofer et al. 2009; Wardlaw et al. 2009; Klazen et al. 2010; Liu et al. 2010; Santiago et al. 2010; Boonen et al. 2011).  At the same time there is evidence that not all patients with vertebral compression fractures benefit from these procedures (Buchbinder et al. 2009; Kalmes et al. 2009; Rousing et al. 2009; Wardlaw et al. 2009; Klazan et al. 2010).  Technology assessment efforts and meta-analyses have arrived at different conclusions regarding the value of vertebral augmentation, but are based on different studies depending on the timing of analyses and publications (Taylor et al. 2006a,b; Hulme et al. 2006; Eck et al. 2007; AAOS 2010; Papanastassiou et al. 2011).

Based on current evidence and in the interest of our patients ISASS offers the following guidelines:

  1. The presence of a vertebral compression fracture is not by itself an indication for vertebral augmentation.
  2. Patients with back pain and vertebral compression fractures should be carefully evaluated to determine if other reasons for pain exist.
  3. Patients with painful vertebral fractures, where other causes of pain have been evaluated, are candidates for vertebral augmentation when they fail non-operative treatment.  This is particularly the case when the pain is increasing or disabling or there is progressive collapse of the fracture.
  4. The patient should be evaluated with an MRI to determine that it has not healed and that there are no additional fractures which were missed on the x-ray.  A bone scan is also helpful in this respect.
  5. Vertebral augmentation procedures are not the same. Studies of VP cannot be used to evaluate studies of BKP and vice versa.

References

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 Oct;17(10):1380-90.

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 Aug 6;361(6):569-79.

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 Aug 6;361(6):557-68.

Rousing R, Andersen MO, Jespersen SM, Thomsen K, Lauritsen J. Percutaneous vertebroplasty compared to conservative treatment in patients with painful acute or subacute osteoporotic vertebral fractures: three-months follow-up in a clinical randomized study. Spine (Phila Pa 1976). 2009 Jun 1;34(13):1349-54.

Grafe IA, Da Fonseca K, Hillmeier J, Meeder PJ, Libicher M, Noldge G, et al. Reduction of pain and fracture incidence after kyphoplasty: 1-year outcomes of a prospective controlled trial of patients with primary osteoporosis. Osteoporos Int. 2005 Dec;16(12):2005-12.

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 Mar 21;373(9668):1016-24.

Grohs JG, Matzner M, Trieb K, Krepler P. Minimal invasive stabilization of osteoporotic vertebral fractures: a prospective nonrandomized comparison of vertebroplasty and balloon kyphoplasty. J Spinal Disord Tech. 2005 Jun;18(3):238-42.

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.  Feb;21(2):359-64.

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 Jun;18 Suppl 1:95-101.

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 Jun;23(5):425-30.

Santiago FR, Abela AP, Alvarez LG, Osuna RM, Garcia MD. Pain and functional outcome after vertebroplasty and kyphoplasty. A comparative study. Eur J Radiol. 2010 Feb 5.

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 Oct;129(10):1391-9.

Alvarez L, Alcaraz M, Perez-Higueras A, Granizo JJ, de Miguel I, Rossi RE, et al. Percutaneous vertebroplasty: functional improvement in patients with osteoporotic compression fractures. Spine (Phila Pa 1976). 2006 May 1;31(10):1113-8.

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 Aug 9.

Berlemann U, Franz T, Orler R, Heini PF. Kyphoplasty for treatment of osteoporotic vertebral fractures: a prospective non-randomized study. Eur Spine J. 2004 Oct;13(6):496-501.

AAOS.  The treatment of symptomatic osteoporotic spinal compression fractures.  Guideline and evidence report, AAOS, Rosemont, 2010.

Papanastassiou ID, Phillips FM, Meirhaeghe JV, et al.  Comparing effects of kyphoplasty, vertebroplasty, and nonsurgical management in a meta-analysis of randomized and nonrandomized controlled studies.  Spine 2011, in review.

Johnell O, Karns JA.  An estimate of the worldwide prevalence and disability associated with osteoporotic fractures.  Osteoporosis Int.  2006: 17(12): 1726-33.

Old JL, Calvert M.  Vertebral compression fractures in the elderly.  Am Fam Physician 2004; 69(1):  111-6.

Borgstrom F, Zethraeus N, Johnell O et al.  costs and quality of life associated with osteoporosis-related fractures in Sweden.  Osteoporosis Int.  2006; 14(7): 589-94.

Eck JC, Nachtigall D, Humphrey 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.

Taylor RS, Fritzell P, Taylor RJ.  Baloon kyphoplasty in the management of vertebral compression fractures:  an updated systematic review and meta-analysis.  Eur. Spine J. 2007; 16(8):  1085-100.

Taylor RS, Taylor RJ, Fritzell P.  Baloon kyphoplasty and vertebroplasty for vertebral compression fractures:  a comparative systematic review of efficacy and safety.  Spine 2006; 31(23):  2747-55.

Hulme, PA, Krebs J, Fergusson SJ et al.  Vertebroplasty and kyphoplasty:  a systematic review of 69 clinical studies.  Spine 2006; 31: 1983-2001.

Boonen S, Van Meirhaeghe J, Bastian L, Cummings SR, Ranstam J, Tillman JB, Eastell R, Talmadge K, Wardlaw D.  Balloon kyphoplasty for the treatment of acute vertebral compression fractures:  2-year results from a randomized trial.  J Bone Miner Res. 2011 Feb 17. Doi: 10.001/jbmr.364 [Epub ahead of print]