Percutaneous Stabilization System Osseofix® for Treatment of Osteoporotic Vertebral Compression Fractures - Clinical and Radiological Results after 12 Months
A prospective consecutive cohort study (follow-up study). Our study investigated whether implantation of an expandable titanium mesh cage (Osseofix®) is a successful and safe minimally invasive therapy for osteoporotic vertebral compression fractures (VCF). Our experiences, clinical and radiological...
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creator | Ender, Stephan Albrecht Wetterau, Elmar Ender, Michaela Kühn, Jens-Peter Merk, Harry Rudolf Kayser, Ralph |
description | A prospective consecutive cohort study (follow-up study).
Our study investigated whether implantation of an expandable titanium mesh cage (Osseofix®) is a successful and safe minimally invasive therapy for osteoporotic vertebral compression fractures (VCF). Our experiences, clinical and radiological findings after 12 months follow-up are presented. Kypho- and vertebroplasty are well-established minimally invasive procedures for the treatment of osteoporotic VCF. The main complications associated with both procedures are uncontrolled bone cement leakage. Therefore a suitable alternative has been investigated.
During June 2010 to May 2011 24 patients were included with 32 osteoporotic VCF (T6 to L4). All of them were stabilized with the Osseofix® system. Preinterventionally we performed X-ray, MRI, and bone density measurements (DXA). Clinical and radiological results were evaluated preop., postop. and after 12 months postop. based on the Oswestry Disability Index (ODI) and the Visual Analogue Scale (VAS), X-ray (Beck Index, Cobb-angle) and CT.
There was a significant improvement in the mean ODI (70,6% to 30,1%) as well as a significant reduction in pain intensity (VAS) (7,7 to 1,4) after 12 month. The mean kyphotic angle according to Cobb showed significant improvements (11,7° to 10,4°) after 12 months. Postinterventional imaging showed only one case of loss of height in a stabilized vertebral body (3.1%). We saw no changes in posterior vertebral wall or adjacent fractures. Except for one pronounced postoperative hematoma we saw no surgical complications including no cement leakage.
Stabilization of symptomatic osteoporotic VCF with Osseofix® system is a safe and effective procedure, even in fractures with posterior wall involvement. The clinical mid-term results are good at a very low complication rate. The Osseofix® system is an interesting alternative to the established procedures of cement augmentation. |
doi_str_mv | 10.1371/journal.pone.0065119 |
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Our study investigated whether implantation of an expandable titanium mesh cage (Osseofix®) is a successful and safe minimally invasive therapy for osteoporotic vertebral compression fractures (VCF). Our experiences, clinical and radiological findings after 12 months follow-up are presented. Kypho- and vertebroplasty are well-established minimally invasive procedures for the treatment of osteoporotic VCF. The main complications associated with both procedures are uncontrolled bone cement leakage. Therefore a suitable alternative has been investigated.
During June 2010 to May 2011 24 patients were included with 32 osteoporotic VCF (T6 to L4). All of them were stabilized with the Osseofix® system. Preinterventionally we performed X-ray, MRI, and bone density measurements (DXA). Clinical and radiological results were evaluated preop., postop. and after 12 months postop. based on the Oswestry Disability Index (ODI) and the Visual Analogue Scale (VAS), X-ray (Beck Index, Cobb-angle) and CT.
There was a significant improvement in the mean ODI (70,6% to 30,1%) as well as a significant reduction in pain intensity (VAS) (7,7 to 1,4) after 12 month. The mean kyphotic angle according to Cobb showed significant improvements (11,7° to 10,4°) after 12 months. Postinterventional imaging showed only one case of loss of height in a stabilized vertebral body (3.1%). We saw no changes in posterior vertebral wall or adjacent fractures. Except for one pronounced postoperative hematoma we saw no surgical complications including no cement leakage.
Stabilization of symptomatic osteoporotic VCF with Osseofix® system is a safe and effective procedure, even in fractures with posterior wall involvement. The clinical mid-term results are good at a very low complication rate. The Osseofix® system is an interesting alternative to the established procedures of cement augmentation.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0065119</identifier><identifier>PMID: 23840316</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Aged ; Aged, 80 and over ; Biology ; Biomedical materials ; Bone cements ; Bone density ; Bone implants ; Bone surgery ; Cement ; Complications ; Compression ; Computed tomography ; Dual energy X-ray absorptiometry ; Ethics ; Female ; Follow-Up Studies ; Fracture Fixation, Internal - adverse effects ; Fracture Fixation, Internal - instrumentation ; Fractures ; Fractures, Compression - diagnostic imaging ; Fractures, Compression - surgery ; Hematoma ; Humans ; Leakage ; Magnetic resonance imaging ; Male ; Medicine ; Middle Aged ; Orthopedics ; Osteoporosis ; Osteoporotic Fractures - diagnostic imaging ; Osteoporotic Fractures - surgery ; Pain ; Patient satisfaction ; Stabilization ; Surgery ; Surgical mesh ; Titanium ; Titanium alloys ; Tomography, X-Ray Computed ; Transplants & implants ; Treatment Outcome ; Vertebra ; Vertebrae</subject><ispartof>PloS one, 2013-06, Vol.8 (6), p.e65119-e65119</ispartof><rights>2013 Ender et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License: https://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2013 Ender et al 2013 Ender et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c526t-1588b889b848c1282349d1c5978166f61dbf4da2070faa41fcf73e0578b6063e3</citedby><cites>FETCH-LOGICAL-c526t-1588b889b848c1282349d1c5978166f61dbf4da2070faa41fcf73e0578b6063e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3694101/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3694101/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,725,778,782,862,883,2098,2917,23849,27907,27908,53774,53776,79351,79352</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23840316$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Eldabe, Sam</contributor><creatorcontrib>Ender, Stephan Albrecht</creatorcontrib><creatorcontrib>Wetterau, Elmar</creatorcontrib><creatorcontrib>Ender, Michaela</creatorcontrib><creatorcontrib>Kühn, Jens-Peter</creatorcontrib><creatorcontrib>Merk, Harry Rudolf</creatorcontrib><creatorcontrib>Kayser, Ralph</creatorcontrib><title>Percutaneous Stabilization System Osseofix® for Treatment of Osteoporotic Vertebral Compression Fractures - Clinical and Radiological Results after 12 Months</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>A prospective consecutive cohort study (follow-up study).
Our study investigated whether implantation of an expandable titanium mesh cage (Osseofix®) is a successful and safe minimally invasive therapy for osteoporotic vertebral compression fractures (VCF). Our experiences, clinical and radiological findings after 12 months follow-up are presented. Kypho- and vertebroplasty are well-established minimally invasive procedures for the treatment of osteoporotic VCF. The main complications associated with both procedures are uncontrolled bone cement leakage. Therefore a suitable alternative has been investigated.
During June 2010 to May 2011 24 patients were included with 32 osteoporotic VCF (T6 to L4). All of them were stabilized with the Osseofix® system. Preinterventionally we performed X-ray, MRI, and bone density measurements (DXA). Clinical and radiological results were evaluated preop., postop. and after 12 months postop. based on the Oswestry Disability Index (ODI) and the Visual Analogue Scale (VAS), X-ray (Beck Index, Cobb-angle) and CT.
There was a significant improvement in the mean ODI (70,6% to 30,1%) as well as a significant reduction in pain intensity (VAS) (7,7 to 1,4) after 12 month. The mean kyphotic angle according to Cobb showed significant improvements (11,7° to 10,4°) after 12 months. Postinterventional imaging showed only one case of loss of height in a stabilized vertebral body (3.1%). We saw no changes in posterior vertebral wall or adjacent fractures. Except for one pronounced postoperative hematoma we saw no surgical complications including no cement leakage.
Stabilization of symptomatic osteoporotic VCF with Osseofix® system is a safe and effective procedure, even in fractures with posterior wall involvement. The clinical mid-term results are good at a very low complication rate. The Osseofix® system is an interesting alternative to the established procedures of cement augmentation.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Biology</subject><subject>Biomedical materials</subject><subject>Bone cements</subject><subject>Bone density</subject><subject>Bone implants</subject><subject>Bone surgery</subject><subject>Cement</subject><subject>Complications</subject><subject>Compression</subject><subject>Computed tomography</subject><subject>Dual energy X-ray absorptiometry</subject><subject>Ethics</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Fracture Fixation, Internal - adverse effects</subject><subject>Fracture Fixation, Internal - instrumentation</subject><subject>Fractures</subject><subject>Fractures, Compression - diagnostic imaging</subject><subject>Fractures, Compression - surgery</subject><subject>Hematoma</subject><subject>Humans</subject><subject>Leakage</subject><subject>Magnetic resonance imaging</subject><subject>Male</subject><subject>Medicine</subject><subject>Middle Aged</subject><subject>Orthopedics</subject><subject>Osteoporosis</subject><subject>Osteoporotic Fractures - diagnostic imaging</subject><subject>Osteoporotic Fractures - surgery</subject><subject>Pain</subject><subject>Patient satisfaction</subject><subject>Stabilization</subject><subject>Surgery</subject><subject>Surgical mesh</subject><subject>Titanium</subject><subject>Titanium alloys</subject><subject>Tomography, X-Ray Computed</subject><subject>Transplants & implants</subject><subject>Treatment Outcome</subject><subject>Vertebra</subject><subject>Vertebrae</subject><issn>1932-6203</issn><issn>1932-6203</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>DOA</sourceid><recordid>eNptkt1uFCEUxydGY2v1DYySeOPNrnzMMHBjYjZWm9TUtNVbwjCHLRtmWIEx1ofxEXwIn0z2o01rvAIOv_PnnD-nqp4TPCesJW9WYYqj9vN1GGGOMW8IkQ-qQyIZnXGK2cM7-4PqSUorjBsmOH9cHVAmaswIP6x-fYZopqxHCFNCF1l3zrufOrswoovrlGFAZylBsO7Hn9_IhoguI-g8wJhRsOUuQ1iHGLIz6CvEDF3UHi3CsI6Q0kblOGqTp3JCM7TwbnSmAHrs0bnuXfBhuQ2cQ5p8TkjbDBERij6FMV-lp9Ujq32CZ_v1qPpy_P5y8XF2evbhZPHudGYayvOMNEJ0QshO1MIQKiirZU9MI1tBOLec9J2te01xi63WNbHGtgxw04qOY86AHVUvd7prH5LaW5vUxmjBsKR1IU52RB_0Sq2jG3S8VkE7tQ2EuFQ6Fhc8KNY1LcVaGgqkllR2NaXa9LQUaCywvmi93b82dQP0pphZXLsnev9mdFdqGb4rxmVNMCkCr_cCMXybIGU1uGTA-90_KtJK0ta8kbSgr_5B_99dvaNMDClFsLfFELzlbrLUZtzUftxK2ou7jdwm3cwX-wuKidbE</recordid><startdate>20130626</startdate><enddate>20130626</enddate><creator>Ender, Stephan Albrecht</creator><creator>Wetterau, Elmar</creator><creator>Ender, Michaela</creator><creator>Kühn, Jens-Peter</creator><creator>Merk, Harry Rudolf</creator><creator>Kayser, Ralph</creator><general>Public Library of Science</general><general>Public Library of Science (PLoS)</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QG</scope><scope>7QL</scope><scope>7QO</scope><scope>7RV</scope><scope>7SN</scope><scope>7SS</scope><scope>7T5</scope><scope>7TG</scope><scope>7TM</scope><scope>7U9</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FE</scope><scope>8FG</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABJCF</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>ARAPS</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BGLVJ</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>D1I</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB.</scope><scope>KB0</scope><scope>KL.</scope><scope>L6V</scope><scope>LK8</scope><scope>M0K</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>M7P</scope><scope>M7S</scope><scope>NAPCQ</scope><scope>P5Z</scope><scope>P62</scope><scope>P64</scope><scope>PATMY</scope><scope>PDBOC</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PTHSS</scope><scope>PYCSY</scope><scope>RC3</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20130626</creationdate><title>Percutaneous Stabilization System Osseofix® for Treatment of Osteoporotic Vertebral Compression Fractures - Clinical and Radiological Results after 12 Months</title><author>Ender, Stephan Albrecht ; Wetterau, Elmar ; Ender, Michaela ; Kühn, Jens-Peter ; Merk, Harry Rudolf ; Kayser, Ralph</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c526t-1588b889b848c1282349d1c5978166f61dbf4da2070faa41fcf73e0578b6063e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Biology</topic><topic>Biomedical materials</topic><topic>Bone cements</topic><topic>Bone density</topic><topic>Bone implants</topic><topic>Bone surgery</topic><topic>Cement</topic><topic>Complications</topic><topic>Compression</topic><topic>Computed tomography</topic><topic>Dual energy X-ray absorptiometry</topic><topic>Ethics</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Fracture Fixation, Internal - adverse effects</topic><topic>Fracture Fixation, Internal - instrumentation</topic><topic>Fractures</topic><topic>Fractures, Compression - diagnostic imaging</topic><topic>Fractures, Compression - surgery</topic><topic>Hematoma</topic><topic>Humans</topic><topic>Leakage</topic><topic>Magnetic resonance imaging</topic><topic>Male</topic><topic>Medicine</topic><topic>Middle Aged</topic><topic>Orthopedics</topic><topic>Osteoporosis</topic><topic>Osteoporotic Fractures - diagnostic imaging</topic><topic>Osteoporotic Fractures - surgery</topic><topic>Pain</topic><topic>Patient satisfaction</topic><topic>Stabilization</topic><topic>Surgery</topic><topic>Surgical mesh</topic><topic>Titanium</topic><topic>Titanium alloys</topic><topic>Tomography, X-Ray Computed</topic><topic>Transplants & implants</topic><topic>Treatment Outcome</topic><topic>Vertebra</topic><topic>Vertebrae</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ender, Stephan Albrecht</creatorcontrib><creatorcontrib>Wetterau, Elmar</creatorcontrib><creatorcontrib>Ender, Michaela</creatorcontrib><creatorcontrib>Kühn, Jens-Peter</creatorcontrib><creatorcontrib>Merk, Harry Rudolf</creatorcontrib><creatorcontrib>Kayser, Ralph</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Animal Behavior Abstracts</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Biotechnology Research Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Ecology Abstracts</collection><collection>Entomology Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Meteorological & Geoastrophysical Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Agricultural Science Collection</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Technology Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Materials Science & Engineering Collection</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>Advanced Technologies & Aerospace Collection</collection><collection>Agricultural & Environmental Science Collection</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Technology Collection</collection><collection>Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Materials Science Collection</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Materials Science Database</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Meteorological & Geoastrophysical Abstracts - 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Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ender, Stephan Albrecht</au><au>Wetterau, Elmar</au><au>Ender, Michaela</au><au>Kühn, Jens-Peter</au><au>Merk, Harry Rudolf</au><au>Kayser, Ralph</au><au>Eldabe, Sam</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Percutaneous Stabilization System Osseofix® for Treatment of Osteoporotic Vertebral Compression Fractures - Clinical and Radiological Results after 12 Months</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2013-06-26</date><risdate>2013</risdate><volume>8</volume><issue>6</issue><spage>e65119</spage><epage>e65119</epage><pages>e65119-e65119</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>A prospective consecutive cohort study (follow-up study).
Our study investigated whether implantation of an expandable titanium mesh cage (Osseofix®) is a successful and safe minimally invasive therapy for osteoporotic vertebral compression fractures (VCF). Our experiences, clinical and radiological findings after 12 months follow-up are presented. Kypho- and vertebroplasty are well-established minimally invasive procedures for the treatment of osteoporotic VCF. The main complications associated with both procedures are uncontrolled bone cement leakage. Therefore a suitable alternative has been investigated.
During June 2010 to May 2011 24 patients were included with 32 osteoporotic VCF (T6 to L4). All of them were stabilized with the Osseofix® system. Preinterventionally we performed X-ray, MRI, and bone density measurements (DXA). Clinical and radiological results were evaluated preop., postop. and after 12 months postop. based on the Oswestry Disability Index (ODI) and the Visual Analogue Scale (VAS), X-ray (Beck Index, Cobb-angle) and CT.
There was a significant improvement in the mean ODI (70,6% to 30,1%) as well as a significant reduction in pain intensity (VAS) (7,7 to 1,4) after 12 month. The mean kyphotic angle according to Cobb showed significant improvements (11,7° to 10,4°) after 12 months. Postinterventional imaging showed only one case of loss of height in a stabilized vertebral body (3.1%). We saw no changes in posterior vertebral wall or adjacent fractures. Except for one pronounced postoperative hematoma we saw no surgical complications including no cement leakage.
Stabilization of symptomatic osteoporotic VCF with Osseofix® system is a safe and effective procedure, even in fractures with posterior wall involvement. The clinical mid-term results are good at a very low complication rate. The Osseofix® system is an interesting alternative to the established procedures of cement augmentation.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>23840316</pmid><doi>10.1371/journal.pone.0065119</doi><oa>free_for_read</oa></addata></record> |
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source | MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Public Library of Science (PLoS); PubMed Central; Free Full-Text Journals in Chemistry |
subjects | Aged Aged, 80 and over Biology Biomedical materials Bone cements Bone density Bone implants Bone surgery Cement Complications Compression Computed tomography Dual energy X-ray absorptiometry Ethics Female Follow-Up Studies Fracture Fixation, Internal - adverse effects Fracture Fixation, Internal - instrumentation Fractures Fractures, Compression - diagnostic imaging Fractures, Compression - surgery Hematoma Humans Leakage Magnetic resonance imaging Male Medicine Middle Aged Orthopedics Osteoporosis Osteoporotic Fractures - diagnostic imaging Osteoporotic Fractures - surgery Pain Patient satisfaction Stabilization Surgery Surgical mesh Titanium Titanium alloys Tomography, X-Ray Computed Transplants & implants Treatment Outcome Vertebra Vertebrae |
title | Percutaneous Stabilization System Osseofix® for Treatment of Osteoporotic Vertebral Compression Fractures - Clinical and Radiological Results after 12 Months |
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