Treatment Related Health Concerns
A single fracture can generate significant pain and has the potential to shorten a patient’s spine, pushing it forward until it adversely affects the overall spine alignment (kyphosis). Each additional fracture can further increase spinal deformity and generate additional pain.1-3 A change in spinal alignment can compress internal organs and have a negative impact on the patient’s breathing, eating, and digestion. The pain generated from movement of the fracture causes patients to limit their mobility and lead a more sedentary lifestyle. This domino effect can further compound matters by continuing to cause medical problems seemingly unrelated to the spine:
- Reduced mobility, loss of balance, and increased risk of falls4,5
- Reduced lung function6,7
- Reduced ability to take care of one’s self, perform usual work, or retirement activities8-10
- Fewer active days and more days in bed8,11,12
- Decreased appetite and sleep disorders13
- Chronic back pain and fatigue12,14
- Decreased quality of life3,15
- Feelings of isolation and sadness16
- Increased risk for future fracture1,15,17,18
- Increased risk of death17,19
The importance to establish key treatment criteria in minimally invasive spine fracture therapies based per the following clinical studies.
In August 2009, the results of two clinical studies evaluated the benefits of vertebroplasty in patients with osteoporotic compression fractures and published in the New England Journal of Medicine (NEJM). See Table A. The similar conclusions reached by the studies sparked both confusion and controversy.
|A Randomized Trial of Verte-broplasty for Osteoporotic Spinal Fractures20
||David F. Kallmes, et al.
||Improvements in pain in patients treated with vertebroplasty were similar to the improvements in the sham procedure control group
|A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures21
||Rachelle Buchbinder, et al.
||No beneficial effect of vertebroplasty as compared with a sham procedure
The referral community suddenly called into question the clinical efficacy of not only vertebroplasty, but all minimally invasive vertebral compression fracture (VCF) procedures including vertebral augmentation. The medical community who performed these minimally invasive procedures and many professional societies agreed that these studies included inappropriate patient populations, and were not adequately powered to make such broad conclusions regading procedural efficacy. Additionally, these studies compared vertebroplasty to an active sham procedure (Sham surgery (also called placebo surgery) is a simulated surgical intervention that omits the therapeutic treatment) and not the conventional conservative medical therapy. These two study results ultimately contradicted 20 years of positive clinical data resulting from minimally invasive procedures in patients with painful vertebral compression fractures. 22-24
Significant among vertebral compression fracture studies that reported statistically significant clinical results of these minimally invasive procedures, both pre and post the NEJM articles, were those conducted by Wardlaw et al. (2009) and Klazen et al. (2010), which evaluated vertebral augmentation and vertebroplasty respectively. See Table B. Both studies enrolled significantly larger numbers of patients, as study subjects, and reported longer follow-up (1 year) than those reported in NEJM and shared none of the concerns associated with the Kallmes and Buchbinder studies.
|Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial25
||Douglas Wardlaw, et al
||Vertebral augmentation in acute fractures resulted in greater pain relief than conservative (non-surgical) care
|Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fracture (Vertos II): an open-label randomised trial26
||Caroline A. H. Klazen et al
||Vertebroplasty in acute fractures resulted in greater pain relief improvement than conservative treatment
Key criteria for achieving back pain relief
Noteworthy among research statistics was that all four studies touched on similar key criteria: patient selection, age of fracture, and time to treatment. Specifically, it was shown in the Wardlaw and Klazen studies that a more accurate diagnosis of painful vertebral compression fractures that included concordant imaging and physical examination results, the mean fracture age less than 12 weeks, and how soon after fracture patients were treated, had a significant positive impact on the reduction of back pain in patients who underwent vertebral augmentation and vertebroplasty.
- Lindsay R, Pack S, and Li Z. Longitudinal progression of fracture prevalence through a population of postmenopausal women with osteoporosis. Osteoporos Int. 2005;16(3):306-312.
- Black DM, et al. Prevalent vertebral deformities predict hip fractures and new vertebral deformities but not wrist fractures. Study of Osteoporotic Fractures Research Group. J Bone Miner Res. 1999;14(5):821-828.
- van Schoor NM, Smit JH, Twisk JW, Lips P. Impact of vertebral deformities, osteoarthritis, and other chronic diseases on quality of life: a population-based study. Osteoporos Int. 2005;16(7):749-756.
- Sinaki M. Falls, fractures, and hip pads. Curr Osteoporos Rep. 2004;2(4):131-137.
- Sinaki M, Brey RH, Hughes CA, Larson DR, and Kaufman KR. Balance disorder and increased risk of falls in osteoporosis and kyphosis: significance of kyphotic posture and muscle strength. Osteoporos Int. 2005;16(8):1004-1010.
- Schlaich C, et al. Reduced pulmonary function in patients with spinal osteoporotic fractures. Osteoporos Int. 1998;8(3):261-267.
- Leech JA, Dulberg C, Kellie S, Pattee L, and Gay J. Relationship of lung function to severity of osteoporosis in women. Am Rev Respir Dis. 1990;141(1):68-71.
- Lyles KW, et al, Association of osteoporotic vertebral compression fractures with impaired functional status. Am J Med. 1993;94(6):595-601.
- Greendale GA, Barrett-Connor E, Ingles S, and Haile R. Late physical and functional effects of osteoporotic fracture in women: the Rancho Bernardo Study. J Am Geriatr Soc. 1995;43(9):955-961.
- Pluijm SM, Tromp AM, Smit JH, Deeg DJ, and Lips P. Consequences of vertebral deformities in older men and women. J Bone Miner Res. 2000;15(8):1564-1572.
- Fink HA, Ensrud KE, Nelson DB, et al. Disability after clinical fracture in postmenopausal women with low bone density: the fracture intervention trial (FIT). Osteoporos Int. 2003;14(1):69-76.
- Nevitt MC, Ettinger B, Black DM, et al. The association of radiographically detected vertebral fractures with back pain and function: a prospective study. Ann Intern Med. 1998;128(10):793-800.
- Silverman SL. The clinical consequences of vertebral compression fracture. Bone. 1992;13 Suppl 2:S27-31.
- *†Gold DT, Silverman SL. The downward spiral of vertebral osteoporosis: consequences (Monograph). Cedars-Sinai Medical Center 2003.
- Silverman SL, et al. The relationship of health-related quality of life to prevalent and incident vertebral fractures in postmenopausal women with osteoporosis: results from the Multiple Outcomes of Raloxifene Evaluation Study. Arthritis Rheum. 2001;44(11):2611-2619.
- Kado DM, Browner WS, Palermo L, Nevitt MC, Genant HK, and Cummings SR. Vertebral fractures and mortality in older women: a prospective study. Study of Osteoporotic Fractures Research Group. Arch Intern Med. 1999;159(11):1215-1220.
- *Johnell O, Kanis JA, Oden A, et al. Fracture risk following an osteoporotic fracture. Osteoporos Int. 2004;15(3):175-179.
- Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral fracture in the year following a fracture. Jama. 2001;285(3):320-323.
- Kado DM, Huang MH, Karlamangla AS, Barrett-Connor E, and Greendale GA. Hyperkyphotic posture predicts mortality in older community-dwelling men and women: a prospective study. J Am Geriatr Soc. 2004;52(10):1662-1667.
- Kallmes DF, Comstock BA, Heagerty PJ, Turner JA, Wilson DJ, Diamond TH, Edwards R, Gray LA, Stout L, Owen S, Hollingworth W, Ghdoke B, Annesley-Williams DJ, Ralston SH, and Jarvik JG. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009;361(6):569-579
- Buchbinder R, Osborne RH, Ebeling PR, Wark JD, Mitchell P, Wriedt C, Graves S, Staples MP, and Murphy B. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009;361(6):557-568.
- Fischer CG, Vaccaro AR, Whang PG, Prasad SK, Angevine PD, Mulpuri K, Thomas KC, and Patel AA. Evidence-Based Recommendations for Spine Surgery. Spine, 2010;36(14):E897-E903.
- Society of Interventional Radiology. Society of Interventional Radiology Supports Treatment for Painful Spine Fractures: Patient Selection Key. January, 2010.
- Smith SJ, Vlahos A, and Sewall L. An Objection to the New England Journal of Medicine Vertebroplasty Articles. Can Assn of Rad Jour. 2010;61(2):121-122.
- Wardlaw D, Cummings SR, Van Meirhaeghe J, Bastian L, Tillman J, Rastam J, Eastel R, Shabe P, Talmadge K, and Boonen S. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet. 2009;373(9668):1016-1024.
- Klazen CA, Lohle PN, de Vries J, Jansen FH, Tielbeek AV, Blonk MC, Venmans A, van Rooij WJ, Schoemaker MC, Juttmann JR, Lo TH, Verhaar HJ, van der Graaf Y, van Everdingen KJ, Muller AF, Elgersma OE, Halkema DR, Fransen H, Janssens X, Buskens E, and Mali WP. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet. 2010;376(9746):1085-1092
Disclosure: an asterisk (*) denotes that some/all of the authors are paid Kyphon consultants. A cross (†) indicates that research cited may have been funded partially, or in whole, by Kyphon Inc.