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Published in: European Spine Journal 5/2012

01-05-2012 | Original Article

Continuing conservative care versus crossover to radiofrequency kyphoplasty: a comparative effectiveness study on the treatment of vertebral body fractures

Authors: Rahel Bornemann, Michael Hanna, Koroush Kabir, Hans Goost, Dieter C. Wirtz, Robert Pflugmacher

Published in: European Spine Journal | Issue 5/2012

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Abstract

Background

There is controversy about how to treat vertebral fractures. Conservative care is the default approach. Radiofrequency kyphoplasty uses ultrahigh viscosity cement to restore spinal posture and stabilize the fracture. The aims of this study were to compare radiofrequency kyphoplasty to conservative care and assess the usual algorithm of starting all patients on conservative care for 6 weeks before offering surgery.

Methods

Elderly patients with painful osteoporotic vertebral compression fractures were all treated with 6 weeks of conservative care (analgesics, bracing, and physiotherapy). They were then offered the choice of continuing conservative care or crossing over to radiofrequency kyphoplasty, at 6 and 12 weeks. Clinical success was defined as: (1) VAS pain improvement ≥2, (2) final VAS pain ≤5, (3) no functional worsening on ODI.

Results

After the initial 6 weeks of conservative care, only 1 of 65 patients met the criteria for clinical success, and median VAS improvement was 0. After 12 weeks of conservative care, only 5 of 38 patients met the criteria for clinical success, and median VAS improvement was 1. At the 6-week follow-up after radiofrequency kyphoplasty, 31 of 33 surgery patients met the criteria for clinical success, and median VAS improvement was 5.

Conclusion

For the vast majority of patients with a VAS ≥5, conservative care did not provide meaningful clinical improvement. In contrast, nearly all patients who underwent radiofrequency kyphoplasty had rapid substantial improvement. Surgery was clearly much more effective than conservative care and should be offered to patients much sooner.
Literature
1.
go back to reference Buchbinder R, Osborne RH, Ebeling PR, Wark JD, Mitchell P, Wriedt C, Graves S, Staples MP, Murphy B (2009) A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. NEJM 361:557–568PubMedCrossRef Buchbinder R, Osborne RH, Ebeling PR, Wark JD, Mitchell P, Wriedt C, Graves S, Staples MP, Murphy B (2009) A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. NEJM 361:557–568PubMedCrossRef
2.
go back to reference Kalmes DF, Comstock BA, Heagerty PJ et al (2009) A randomized trial of vertebroplasty for osteoporotic spinal fractures. NEJM 361:569–579CrossRef Kalmes DF, Comstock BA, Heagerty PJ et al (2009) A randomized trial of vertebroplasty for osteoporotic spinal fractures. NEJM 361:569–579CrossRef
3.
go back to reference Weinstein JN (2009) Balancing science and informed choice in decisions about vertebroplasty. NEJM 361:619–621PubMedCrossRef Weinstein JN (2009) Balancing science and informed choice in decisions about vertebroplasty. NEJM 361:619–621PubMedCrossRef
4.
go back to reference Aebi M (2009) Vertebroplasty: about sense and nonsense of uncontrolled “controlled randomized prospective trials”. Eur Spine J 18:1247–1248PubMedCrossRef Aebi M (2009) Vertebroplasty: about sense and nonsense of uncontrolled “controlled randomized prospective trials”. Eur Spine J 18:1247–1248PubMedCrossRef
5.
go back to reference Noonan P (2009) Randomized vertebroplasty trials: bad news or sham news? Am J Neuroradiol 30:1808–1809PubMedCrossRef Noonan P (2009) Randomized vertebroplasty trials: bad news or sham news? Am J Neuroradiol 30:1808–1809PubMedCrossRef
6.
go back to reference Kalmes D, Buchbinder R, Jarvik J, Heagerty P, Comstock B, Turner J, Osborne R (2009) Response to “randomized vertebroplasty trials: bad news or sham news?”. Am J Neuroradiol 30:1809–1810CrossRef Kalmes D, Buchbinder R, Jarvik J, Heagerty P, Comstock B, Turner J, Osborne R (2009) Response to “randomized vertebroplasty trials: bad news or sham news?”. Am J Neuroradiol 30:1809–1810CrossRef
7.
go back to reference Buchbinder R, Osborne RH, Kallmes D (2009) Vertebroplasty appears no better than placebo for painful osteoporotic spinal fractures, and has potential to cause harm. MJA 191:476–477PubMed Buchbinder R, Osborne RH, Kallmes D (2009) Vertebroplasty appears no better than placebo for painful osteoporotic spinal fractures, and has potential to cause harm. MJA 191:476–477PubMed
8.
go back to reference Clark WA, Diamond TH, McNeil HP, Gonski PN, Schlaphoff GP, Rouse JC (2010) Vertebroplasty for painful acute osteoporotic vertebral fractures: recent Medical Journal of Australia editorial is not relevant to the patient group that we treat with vertebroplasty. MJA 192:334–337PubMed Clark WA, Diamond TH, McNeil HP, Gonski PN, Schlaphoff GP, Rouse JC (2010) Vertebroplasty for painful acute osteoporotic vertebral fractures: recent Medical Journal of Australia editorial is not relevant to the patient group that we treat with vertebroplasty. MJA 192:334–337PubMed
9.
go back to reference Buchbinder R, Osborne RH, Kallmes D (2010) Invited editorial presents an accurate summary of the results of two randomized placebo-controlled trials of vertebroplasty. MJA 192:338–341PubMed Buchbinder R, Osborne RH, Kallmes D (2010) Invited editorial presents an accurate summary of the results of two randomized placebo-controlled trials of vertebroplasty. MJA 192:338–341PubMed
10.
go back to reference Van Der Weyden MB (2010) Vertebroplasty, evidence and professional protest. MJA 192:301–302 Van Der Weyden MB (2010) Vertebroplasty, evidence and professional protest. MJA 192:301–302
11.
go back to reference Sox HC, Greenfield S (2009) Comparative effectiveness research: a report from the Institute of Medicine. Ann Intern Med 151:203–205PubMed Sox HC, Greenfield S (2009) Comparative effectiveness research: a report from the Institute of Medicine. Ann Intern Med 151:203–205PubMed
12.
go back to reference Luce BR, Kramer JM, Goodman SN, Connor JT, Tunis S, Whicher D, Schwartz JS (2009) Rethinking randomized clinical trials for comparative effectiveness research: the need for transformational change. Ann Intern Med 151:206–209PubMed Luce BR, Kramer JM, Goodman SN, Connor JT, Tunis S, Whicher D, Schwartz JS (2009) Rethinking randomized clinical trials for comparative effectiveness research: the need for transformational change. Ann Intern Med 151:206–209PubMed
13.
go back to reference Schneeweiss S (2009) On guidelines for comparative effectiveness research using nonrandomized studies in secondary data sources. Value Health 12:1041PubMedCrossRef Schneeweiss S (2009) On guidelines for comparative effectiveness research using nonrandomized studies in secondary data sources. Value Health 12:1041PubMedCrossRef
15.
go back to reference Elgeti FA, Marnitz T, Kröncke TJ, Gebauer B (2010) DFine Radiofrequenzkyphoplastie (RFK)—Kyphoplastie mit ultrahochviskösem Zement. RöFo 182:803–805PubMed Elgeti FA, Marnitz T, Kröncke TJ, Gebauer B (2010) DFine Radiofrequenzkyphoplastie (RFK)—Kyphoplastie mit ultrahochviskösem Zement. RöFo 182:803–805PubMed
16.
go back to reference Bae HW, Linovitz R, Maurer P et al (2010) Correlation of early pain and long-term functional results from a multi-center, prospective, randomized, controlled FDA-IDE vertebroplasty trial. Spine J 10:64S–65SCrossRef Bae HW, Linovitz R, Maurer P et al (2010) Correlation of early pain and long-term functional results from a multi-center, prospective, randomized, controlled FDA-IDE vertebroplasty trial. Spine J 10:64S–65SCrossRef
17.
go back to reference Klazen CAH, Lohle PNM, de Vries J et al (2010) Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet 376:1031–1033CrossRef Klazen CAH, Lohle PNM, de Vries J et al (2010) Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet 376:1031–1033CrossRef
18.
go back to reference Wardlaw D, Cummings SR, Van Meirhaeghe J, Bastian L, Tillman JB, Ranstam J, Eastell R, Shabe P, Talmadge K, Boonen S (2009) Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet 373:1016–1024PubMedCrossRef Wardlaw D, Cummings SR, Van Meirhaeghe J, Bastian L, Tillman JB, Ranstam J, Eastell R, Shabe P, Talmadge K, Boonen S (2009) Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet 373:1016–1024PubMedCrossRef
Metadata
Title
Continuing conservative care versus crossover to radiofrequency kyphoplasty: a comparative effectiveness study on the treatment of vertebral body fractures
Authors
Rahel Bornemann
Michael Hanna
Koroush Kabir
Hans Goost
Dieter C. Wirtz
Robert Pflugmacher
Publication date
01-05-2012
Publisher
Springer-Verlag
Published in
European Spine Journal / Issue 5/2012
Print ISSN: 0940-6719
Electronic ISSN: 1432-0932
DOI
https://doi.org/10.1007/s00586-012-2148-8

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