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<meta name="DC.Title" content="A Randomized Trial Comparing Balloon Kyphoplasty and Vertebroplasty for Vertebral Compression Fractures due to Osteoporosis" />
<meta name="DC.Identifier" content="10.3174/ajnr.A4127" />
<meta name="DC.Date" content="2014-12-01" />
<meta name="DC.Publisher" content="American Journal of Neuroradiology" />
<meta name="DC.Rights" content="© 2014 by American Journal of Neuroradiology. 
Indicates open access to non-subscribers at www.ajnr.org" />
<meta name="DC.AccessRights" content="open-access" />
<meta name="DC.Description" content="BACKGROUND AND PURPOSE: Several trials have compared vertebral augmentation with nonsurgical treatment for vertebral compression fractures. This trial compares the efficacy and safety of balloon kyphoplasty and vertebroplasty.

MATERIALS AND METHODS: Patients with osteoporosis with 1–3 acute fractures (T5–L5) were randomized and treated with kyphoplasty ( n = 191) or vertebroplasty ( n = 190) and were not blinded to the treatment assignment. Twelve- and 24-month subsequent radiographic fracture incidence was the primary end point. Due to low enrollment and early withdrawals, the study was terminated with 404/1234 (32.7%) patients enrolled.

RESULTS: The average age of patients was 75.6 years (77.4% female). Mean procedure duration was longer for kyphoplasty (40.0 versus 31.8 minutes, P &lt; .001). At 12 months, 7.8% fewer patients with kyphoplasty (50/140 versus 57/131) had subsequent radiographic fracture, and there were 8.6% fewer at 24 months (54/110 versus 64/111). The results were not statistically significant ( P &gt; .21). When we used time to event for new clinical fractures, kyphoplasty approached statistical significance in longer fracture-free survival (Wilcoxon, P = .0596). Similar pain and function improvements were observed. CT demonstrated lower cement extravasation for kyphoplasty (157/214 versus 164/201 levels treated, P = .047). For kyphoplasty versus vertebroplasty, common adverse events within 30 postoperative days were procedural pain (12/191, 9/190), back pain (14/191, 28/190), and new vertebral fractures (9/191, 17/190); similar 2-year occurrence of device-related cement embolism (1/191, 1/190), procedural pain (3/191, 3/190), back pain (2/191, 3/190), and new vertebral fracture (2/191, 2/190) was observed.

CONCLUSIONS: Kyphoplasty and vertebroplasty had similar long-term improvement in pain and disability with similar safety profiles and few device-related complications. Procedure duration was shorter with vertebroplasty. Kyphoplasty had fewer cement leakages and a trend toward longer fracture-free survival.

AE
:   adverse event
BKP
:   balloon kyphoplasty
EQ-5D
:   EuroQol-5-Domain
KAVIAR
:   Kyphoplasty and Vertebroplasty In the Augmentation and Restoration of vertebral body compression fractures
MedDRA
:   Medical Dictionary for Regulatory Activities
ODI
:   Oswestry Disability Index
RCT
:   randomized controlled trial
VCF
:   vertebral compression fracture
VP
:   vertebroplasty" />
<meta name="DC.Contributor" content="M. Dohm" />
<meta name="DC.Contributor" content="C.M. Black" />
<meta name="DC.Contributor" content="A. Dacre" />
<meta name="DC.Contributor" content="J.B. Tillman" />
<meta name="DC.Contributor" content="G. Fueredi" />
<meta name="article:published_time" content="2014-12-01" />
<meta name="article:section" content="Level 1 EBM Expedited Publication" />
<meta name="citation_title" content="A Randomized Trial Comparing Balloon Kyphoplasty and Vertebroplasty for Vertebral Compression Fractures due to Osteoporosis" />
<meta name="citation_abstract" lang="en" content="&lt;h3&gt;BACKGROUND AND PURPOSE:&lt;/h3&gt;
&lt;p&gt;Several trials have compared vertebral augmentation with nonsurgical treatment for vertebral compression fractures. This trial compares the efficacy and safety of balloon kyphoplasty and vertebroplasty.&lt;/p&gt;&lt;h3&gt;MATERIALS AND METHODS:&lt;/h3&gt;
&lt;p&gt;Patients with osteoporosis with 1–3 acute fractures (T5–L5) were randomized and treated with kyphoplasty (&lt;i&gt;n&lt;/i&gt; = 191) or vertebroplasty (&lt;i&gt;n&lt;/i&gt; = 190) and were not blinded to the treatment assignment. Twelve- and 24-month subsequent radiographic fracture incidence was the primary end point. Due to low enrollment and early withdrawals, the study was terminated with 404/1234 (32.7%) patients enrolled.&lt;/p&gt;&lt;h3&gt;RESULTS:&lt;/h3&gt;
&lt;p&gt;The average age of patients was 75.6 years (77.4% female). Mean procedure duration was longer for kyphoplasty (40.0 versus 31.8 minutes, &lt;i&gt;P&lt;/i&gt; &amp;lt; .001). At 12 months, 7.8% fewer patients with kyphoplasty (50/140 versus 57/131) had subsequent radiographic fracture, and there were 8.6% fewer at 24 months (54/110 versus 64/111). The results were not statistically significant (&lt;i&gt;P&lt;/i&gt; &amp;gt; .21). When we used time to event for new clinical fractures, kyphoplasty approached statistical significance in longer fracture-free survival (Wilcoxon, &lt;i&gt;P&lt;/i&gt; = .0596). Similar pain and function improvements were observed. CT demonstrated lower cement extravasation for kyphoplasty (157/214 versus 164/201 levels treated, &lt;i&gt;P&lt;/i&gt; = .047). For kyphoplasty versus vertebroplasty, common adverse events within 30 postoperative days were procedural pain (12/191, 9/190), back pain (14/191, 28/190), and new vertebral fractures (9/191, 17/190); similar 2-year occurrence of device-related cement embolism (1/191, 1/190), procedural pain (3/191, 3/190), back pain (2/191, 3/190), and new vertebral fracture (2/191, 2/190) was observed.&lt;/p&gt;&lt;h3&gt;CONCLUSIONS:&lt;/h3&gt;
&lt;p&gt;Kyphoplasty and vertebroplasty had similar long-term improvement in pain and disability with similar safety profiles and few device-related complications. Procedure duration was shorter with vertebroplasty. Kyphoplasty had fewer cement leakages and a trend toward longer fracture-free survival.&lt;/p&gt;" />
<meta name="citation_journal_title" content="American Journal of Neuroradiology" />
<meta name="citation_publisher" content="American Journal of Neuroradiology" />
<meta name="citation_publication_date" content="2014/12/01" />
<meta name="citation_mjid" content="ajnr;35/12/2227" />
<meta name="citation_id" content="35/12/2227" />
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<meta name="citation_issn" content="0195-6108" />
<meta name="citation_issn" content="1936-959X" />
<meta name="citation_doi" content="10.3174/ajnr.A4127" />
<meta name="citation_pmid" content="25300981" />
<meta name="citation_volume" content="35" />
<meta name="citation_issue" content="12" />
<meta name="citation_article_type" content="Research Article" />
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<meta name="citation_firstpage" content="2227" />
<meta name="citation_lastpage" content="2236" />
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<meta name="citation_author" content="M. Dohm" />
<meta name="citation_author_institution" content="aFrom the Department of Orthopaedic Surgery, University of Arizona College of Medicine (M.D.), Tucson, Arizona" />
<meta name="citation_author" content="C.M. Black" />
<meta name="citation_author_institution" content="bUtah Valley Interventional Associates and Utah Valley Regional Medical Center (C.M.B.), Provo, Utah" />
<meta name="citation_author" content="A. Dacre" />
<meta name="citation_author_institution" content="cOrthoMontana (A.D.), Billings, Montana" />
<meta name="citation_author" content="J.B. Tillman" />
<meta name="citation_author_institution" content="dMedtronic Spine (J.B.T.), Sunnyvale, California" />
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<meta name="twitter:title" content="A Randomized Trial Comparing Balloon Kyphoplasty and Vertebroplasty for Vertebral Compression Fractures due to Osteoporosis" />
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<meta name="twitter:description" content="BACKGROUND AND PURPOSE: Several trials have compared vertebral augmentation with nonsurgical treatment for vertebral compression fractures. This trial compares the efficacy and safety of balloon kyphoplasty and vertebroplasty.

MATERIALS AND METHODS: Patients with osteoporosis with 1–3 acute fractures (T5–L5) were randomized and treated with kyphoplasty ( n = 191) or vertebroplasty ( n = 190) and were not blinded to the treatment assignment. Twelve- and 24-month subsequent radiographic fracture incidence was the primary end point. Due to low enrollment and early withdrawals, the study was terminated with 404/1234 (32.7%) patients enrolled.

RESULTS: The average age of patients was 75.6 years (77.4% female). Mean procedure duration was longer for kyphoplasty (40.0 versus 31.8 minutes, P &lt; .001). At 12 months, 7.8% fewer patients with kyphoplasty (50/140 versus 57/131) had subsequent radiographic fracture, and there were 8.6% fewer at 24 months (54/110 versus 64/111). The results were not statistically significant ( P &gt; .21). When we used time to event for new clinical fractures, kyphoplasty approached statistical significance in longer fracture-free survival (Wilcoxon, P = .0596). Similar pain and function improvements were observed. CT demonstrated lower cement extravasation for kyphoplasty (157/214 versus 164/201 levels treated, P = .047). For kyphoplasty versus vertebroplasty, common adverse events within 30 postoperative days were procedural pain (12/191, 9/190), back pain (14/191, 28/190), and new vertebral fractures (9/191, 17/190); similar 2-year occurrence of device-related cement embolism (1/191, 1/190), procedural pain (3/191, 3/190), back pain (2/191, 3/190), and new vertebral fracture (2/191, 2/190) was observed.

CONCLUSIONS: Kyphoplasty and vertebroplasty had similar long-term improvement in pain and disability with similar safety profiles and few device-related complications. Procedure duration was shorter with vertebroplasty. Kyphoplasty had fewer cement leakages and a trend toward longer fracture-free survival.

AE
:   adverse event
BKP
:   balloon kyphoplasty
EQ-5D
:   EuroQol-5-Domain
KAVIAR
:   Kyphoplasty and Vertebroplasty In the Augmentation and Restoration of vertebral body compression fractures
MedDRA
:   Medical Dictionary for Regulatory Activities
ODI
:   Oswestry Disability Index
RCT
:   randomized controlled trial
VCF
:   vertebral compression fracture
VP
:   vertebroplasty" />
<meta name="og-title" property="og:title" content="A Randomized Trial Comparing Balloon Kyphoplasty and Vertebroplasty for Vertebral Compression Fractures due to Osteoporosis" />
<meta name="og-url" property="og:url" content="http://ajnr-stage2.stage.highwire.org/content/35/12/2227" />
<meta name="og-site-name" property="og:site_name" content="American Journal of Neuroradiology" />
<meta name="og-description" property="og:description" content="BACKGROUND AND PURPOSE: Several trials have compared vertebral augmentation with nonsurgical treatment for vertebral compression fractures. This trial compares the efficacy and safety of balloon kyphoplasty and vertebroplasty.

MATERIALS AND METHODS: Patients with osteoporosis with 1–3 acute fractures (T5–L5) were randomized and treated with kyphoplasty ( n = 191) or vertebroplasty ( n = 190) and were not blinded to the treatment assignment. Twelve- and 24-month subsequent radiographic fracture incidence was the primary end point. Due to low enrollment and early withdrawals, the study was terminated with 404/1234 (32.7%) patients enrolled.

RESULTS: The average age of patients was 75.6 years (77.4% female). Mean procedure duration was longer for kyphoplasty (40.0 versus 31.8 minutes, P &lt; .001). At 12 months, 7.8% fewer patients with kyphoplasty (50/140 versus 57/131) had subsequent radiographic fracture, and there were 8.6% fewer at 24 months (54/110 versus 64/111). The results were not statistically significant ( P &gt; .21). When we used time to event for new clinical fractures, kyphoplasty approached statistical significance in longer fracture-free survival (Wilcoxon, P = .0596). Similar pain and function improvements were observed. CT demonstrated lower cement extravasation for kyphoplasty (157/214 versus 164/201 levels treated, P = .047). For kyphoplasty versus vertebroplasty, common adverse events within 30 postoperative days were procedural pain (12/191, 9/190), back pain (14/191, 28/190), and new vertebral fractures (9/191, 17/190); similar 2-year occurrence of device-related cement embolism (1/191, 1/190), procedural pain (3/191, 3/190), back pain (2/191, 3/190), and new vertebral fracture (2/191, 2/190) was observed.

CONCLUSIONS: Kyphoplasty and vertebroplasty had similar long-term improvement in pain and disability with similar safety profiles and few device-related complications. Procedure duration was shorter with vertebroplasty. Kyphoplasty had fewer cement leakages and a trend toward longer fracture-free survival.

AE
:   adverse event
BKP
:   balloon kyphoplasty
EQ-5D
:   EuroQol-5-Domain
KAVIAR
:   Kyphoplasty and Vertebroplasty In the Augmentation and Restoration of vertebral body compression fractures
MedDRA
:   Medical Dictionary for Regulatory Activities
ODI
:   Oswestry Disability Index
RCT
:   randomized controlled trial
VCF
:   vertebral compression fracture
VP
:   vertebroplasty" />
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    	<div class="highwire-cite-metadata"><span  class="highwire-cite-metadata-journal highwire-cite-metadata">American Journal of Neuroradiology </span><span  class="highwire-cite-metadata-date highwire-cite-metadata">December 2014,  </span><span  class="highwire-cite-metadata-volume highwire-cite-metadata">35 </span><span  class="highwire-cite-metadata-issue highwire-cite-metadata">(12) </span><span  class="highwire-cite-metadata-pages highwire-cite-metadata">2227-2236; </span><span  class="highwire-cite-metadata-doi highwire-cite-metadata">DOI: https://doi.org/10.3174/ajnr.A4127 </span></div>
  
  
  
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Black </div><div class="author-tooltip-affiliation"><span class="author-tooltip-text"><div class='author-affiliation'><span class='nlm-sup'>b</span>Utah Valley Interventional Associates and Utah Valley Regional Medical Center (C.M.B.), Provo, Utah</div></span></div><ul class="author-tooltip-find-more"><li class="author-tooltip-gs-link first"><a href="/lookup/google-scholar?link_type=googlescholar&amp;gs_type=author&amp;author%5B0%5D=C.M.%2BBlack%2B" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on Google Scholar</a></li><li class="author-tooltip-pubmed-link"><a href="/lookup/external-ref?access_num=Black%20C&amp;link_type=AUTHORSEARCH" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on PubMed</a></li><li class="author-site-search-link last"><a href="/search/author1%3AC.M.%2BBlack%2B" rel="nofollow" class="" data-icon-position="" data-hide-link-title="0">Search for this author on this site</a></li></ul></div><div class="author-tooltip-2"><div class="author-tooltip-name">A. Dacre </div><div class="author-tooltip-affiliation"><span class="author-tooltip-text"><div class='author-affiliation'><span class='nlm-sup'>c</span>OrthoMontana (A.D.), Billings, Montana</div></span></div><ul class="author-tooltip-find-more"><li class="author-tooltip-gs-link first"><a href="/lookup/google-scholar?link_type=googlescholar&amp;gs_type=author&amp;author%5B0%5D=A.%2BDacre%2B" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on Google Scholar</a></li><li class="author-tooltip-pubmed-link"><a href="/lookup/external-ref?access_num=Dacre%20A&amp;link_type=AUTHORSEARCH" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on PubMed</a></li><li class="author-site-search-link last"><a href="/search/author1%3AA.%2BDacre%2B" rel="nofollow" class="" data-icon-position="" data-hide-link-title="0">Search for this author on this site</a></li></ul></div><div class="author-tooltip-3"><div class="author-tooltip-name">J.B. Tillman </div><div class="author-tooltip-affiliation"><span class="author-tooltip-text"><div class='author-affiliation'><span class='nlm-sup'>d</span>Medtronic Spine (J.B.T.), Sunnyvale, California</div></span></div><ul class="author-tooltip-find-more"><li class="author-tooltip-gs-link first"><a href="/lookup/google-scholar?link_type=googlescholar&amp;gs_type=author&amp;author%5B0%5D=J.B.%2BTillman%2B" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on Google Scholar</a></li><li class="author-tooltip-pubmed-link"><a href="/lookup/external-ref?access_num=Tillman%20J&amp;link_type=AUTHORSEARCH" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on PubMed</a></li><li class="author-site-search-link last"><a href="/search/author1%3AJ.B.%2BTillman%2B" rel="nofollow" class="" data-icon-position="" data-hide-link-title="0">Search for this author on this site</a></li></ul></div><div class="author-tooltip-4"><div class="author-tooltip-name">G. 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      <div class="highwire-cite-title">A Randomized Trial Comparing Balloon Kyphoplasty and Vertebroplasty for Vertebral Compression Fractures due to Osteoporosis</div>  
    	<div class="highwire-cite-authors"><span  class="highwire-citation-authors"><span class="highwire-citation-author first" data-delta="0"><span class="nlm-given-names">M.</span> <span class="nlm-surname">Dohm</span></span>, <span class="highwire-citation-author" data-delta="1"><span class="nlm-given-names">C.M.</span> <span class="nlm-surname">Black</span></span>, <span class="highwire-citation-author" data-delta="2"><span class="nlm-given-names">A.</span> <span class="nlm-surname">Dacre</span></span>, <span class="highwire-citation-author" data-delta="3"><span class="nlm-given-names">J.B.</span> <span class="nlm-surname">Tillman</span></span>, <span class="highwire-citation-author" data-delta="4"><span class="nlm-given-names">G.</span> <span class="nlm-surname">Fueredi</span></span></span></div>
  
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