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Extracorporeal Shock Wave Treatment of Non- or Delayed Union of Proximal Metatarsal Fractures
Background: Nonunion or delayed union of fractures in the proximal aspect of metatarsals 1 to 4 and Zone 2 of the fifth metatarsal were treated by high energy extracorporeal shock wave treatment (ESWT) to study the safety and efficacy of this method of treatment in a FDA study of the Ossatron device...
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| Published in: | Foot & ankle international 2011-08, Vol.32 (8), p.746-754 |
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| Main Authors: | , , , , , , , , |
| Format: | Article |
| Language: | English |
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| cites | cdi_FETCH-LOGICAL-c327t-52f34deac1a54f72010a442d1d4a96b60ddc367f7acd9720931daaf3068f2c93 |
| container_end_page | 754 |
| container_issue | 8 |
| container_start_page | 746 |
| container_title | Foot & ankle international |
| container_volume | 32 |
| creator | Alvarez, Richard G. Cincere, Brandon Channappa, Chandra Langerman, Richard Schulte, Robert Jaakkola, Juha Melancon, Keith Shereff, Michael Lee Cross, G. |
| description | Background:
Nonunion or delayed union of fractures in the proximal aspect of metatarsals 1 to 4 and Zone 2 of the fifth metatarsal were treated by high energy extracorporeal shock wave treatment (ESWT) to study the safety and efficacy of this method of treatment in a FDA study of the Ossatron device.
Materials and Methods:
In a prospective single-arm, multi-center study, 34 fractures were treated in 32 patients (two subjects had two independent fractures) with ESWT. All fractures were at least 10 (range, 10 to 833) weeks after injury, with a median of 23 weeks. ESWT application was conducted using a protocol totaling 2,000 shocks for a total energy application of approximately 0.22 to 0.51 mJ/mm2 per treatment. The mean ESWT application time for each of the treatments was 24.6 ± 16.6 minutes, and anesthesia time averaged 27.1 ± 10.4 minutes. All subjects were followed for 1 year after treatment at intervals of 12 weeks, 6, 9, and 12 months.
Results:
The overall success rate at the 12-week visit was 71% with low complications, significant pain improvement as well as improvement on the SF-36. The success/fail criteria was evaluated again at the 6- and 12-month followup, showing treatment success rates of 89% (23/26) and 90% (18/20), respectively. The most common adverse event was swelling in the foot, reported by five subjects (15.6%).
Conclusion:
High-energy ESWT appears to be effective and safe in patients for treatment of nonunion or a delayed healing of a proximal metatarsal, and in fifth metatarsal fractures in Zone 2.
Level of Evidence: IV, Retrospective Case Series |
| doi_str_mv | 10.3113/FAI.2011.0746 |
| format | article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_902329561</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sage_id>10.3113_FAI.2011.0746</sage_id><sourcerecordid>902329561</sourcerecordid><originalsourceid>FETCH-LOGICAL-c327t-52f34deac1a54f72010a442d1d4a96b60ddc367f7acd9720931daaf3068f2c93</originalsourceid><addsrcrecordid>eNp1kMtPAjEQhxujEUSPXk1vJiaLfbGlR4KgJPhIxHgyTelDwWWL7a6B_95uQG-eOul888vMB8A5Rl2KMb0eDyZdgjDuIs7yA9DGgrGM93l-mGrEcYYR4i1wEuMSIcwpFsegRQhiop-jNngbbaqgtA9rH6wq4POH15_wVX1bOEsf1cqWFfQOPvgygz7AG1uorTXwpVz4smk8Bb9ZrNLkva1UpUJM5TglVnWw8RQcOVVEe7Z_O2A2Hs2Gd9n08XYyHEwzTQmvsh5xlBmrNFY95ng6BynGiMGGKZHPc2SMpjl3XGkjUltQbJRyFOV9R7SgHXC5i10H_1XbWMnVImpbFKq0vo5SIEKJ6OU4kdmO1MHHGKyT65C2D1uJkWx8yuRTNj5l4zPxF_vker6y5o_-FZiAqx0Q1buVS1-HMh36T9oPbop9Fw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>902329561</pqid></control><display><type>article</type><title>Extracorporeal Shock Wave Treatment of Non- or Delayed Union of Proximal Metatarsal Fractures</title><source>SAGE</source><creator>Alvarez, Richard G. ; Cincere, Brandon ; Channappa, Chandra ; Langerman, Richard ; Schulte, Robert ; Jaakkola, Juha ; Melancon, Keith ; Shereff, Michael ; Lee Cross, G.</creator><creatorcontrib>Alvarez, Richard G. ; Cincere, Brandon ; Channappa, Chandra ; Langerman, Richard ; Schulte, Robert ; Jaakkola, Juha ; Melancon, Keith ; Shereff, Michael ; Lee Cross, G.</creatorcontrib><description>Background:
Nonunion or delayed union of fractures in the proximal aspect of metatarsals 1 to 4 and Zone 2 of the fifth metatarsal were treated by high energy extracorporeal shock wave treatment (ESWT) to study the safety and efficacy of this method of treatment in a FDA study of the Ossatron device.
Materials and Methods:
In a prospective single-arm, multi-center study, 34 fractures were treated in 32 patients (two subjects had two independent fractures) with ESWT. All fractures were at least 10 (range, 10 to 833) weeks after injury, with a median of 23 weeks. ESWT application was conducted using a protocol totaling 2,000 shocks for a total energy application of approximately 0.22 to 0.51 mJ/mm2 per treatment. The mean ESWT application time for each of the treatments was 24.6 ± 16.6 minutes, and anesthesia time averaged 27.1 ± 10.4 minutes. All subjects were followed for 1 year after treatment at intervals of 12 weeks, 6, 9, and 12 months.
Results:
The overall success rate at the 12-week visit was 71% with low complications, significant pain improvement as well as improvement on the SF-36. The success/fail criteria was evaluated again at the 6- and 12-month followup, showing treatment success rates of 89% (23/26) and 90% (18/20), respectively. The most common adverse event was swelling in the foot, reported by five subjects (15.6%).
Conclusion:
High-energy ESWT appears to be effective and safe in patients for treatment of nonunion or a delayed healing of a proximal metatarsal, and in fifth metatarsal fractures in Zone 2.
Level of Evidence: IV, Retrospective Case Series</description><identifier>ISSN: 1071-1007</identifier><identifier>EISSN: 1944-7876</identifier><identifier>DOI: 10.3113/FAI.2011.0746</identifier><identifier>PMID: 22049860</identifier><language>eng</language><publisher>Los Angeles, CA: SAGE Publications</publisher><subject>Adolescent ; Adult ; Aged ; Female ; Fractures, Bone - therapy ; Fractures, Ununited - therapy ; Health Status Indicators ; High-Energy Shock Waves - therapeutic use ; Humans ; Male ; Metatarsal Bones - injuries ; Middle Aged ; Prospective Studies ; Treatment Outcome ; Young Adult</subject><ispartof>Foot & ankle international, 2011-08, Vol.32 (8), p.746-754</ispartof><rights>2011 American Orthopaedic Foot & Ankle Society</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c327t-52f34deac1a54f72010a442d1d4a96b60ddc367f7acd9720931daaf3068f2c93</citedby><cites>FETCH-LOGICAL-c327t-52f34deac1a54f72010a442d1d4a96b60ddc367f7acd9720931daaf3068f2c93</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925,79364</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22049860$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Alvarez, Richard G.</creatorcontrib><creatorcontrib>Cincere, Brandon</creatorcontrib><creatorcontrib>Channappa, Chandra</creatorcontrib><creatorcontrib>Langerman, Richard</creatorcontrib><creatorcontrib>Schulte, Robert</creatorcontrib><creatorcontrib>Jaakkola, Juha</creatorcontrib><creatorcontrib>Melancon, Keith</creatorcontrib><creatorcontrib>Shereff, Michael</creatorcontrib><creatorcontrib>Lee Cross, G.</creatorcontrib><title>Extracorporeal Shock Wave Treatment of Non- or Delayed Union of Proximal Metatarsal Fractures</title><title>Foot & ankle international</title><addtitle>Foot Ankle Int</addtitle><description>Background:
Nonunion or delayed union of fractures in the proximal aspect of metatarsals 1 to 4 and Zone 2 of the fifth metatarsal were treated by high energy extracorporeal shock wave treatment (ESWT) to study the safety and efficacy of this method of treatment in a FDA study of the Ossatron device.
Materials and Methods:
In a prospective single-arm, multi-center study, 34 fractures were treated in 32 patients (two subjects had two independent fractures) with ESWT. All fractures were at least 10 (range, 10 to 833) weeks after injury, with a median of 23 weeks. ESWT application was conducted using a protocol totaling 2,000 shocks for a total energy application of approximately 0.22 to 0.51 mJ/mm2 per treatment. The mean ESWT application time for each of the treatments was 24.6 ± 16.6 minutes, and anesthesia time averaged 27.1 ± 10.4 minutes. All subjects were followed for 1 year after treatment at intervals of 12 weeks, 6, 9, and 12 months.
Results:
The overall success rate at the 12-week visit was 71% with low complications, significant pain improvement as well as improvement on the SF-36. The success/fail criteria was evaluated again at the 6- and 12-month followup, showing treatment success rates of 89% (23/26) and 90% (18/20), respectively. The most common adverse event was swelling in the foot, reported by five subjects (15.6%).
Conclusion:
High-energy ESWT appears to be effective and safe in patients for treatment of nonunion or a delayed healing of a proximal metatarsal, and in fifth metatarsal fractures in Zone 2.
Level of Evidence: IV, Retrospective Case Series</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Female</subject><subject>Fractures, Bone - therapy</subject><subject>Fractures, Ununited - therapy</subject><subject>Health Status Indicators</subject><subject>High-Energy Shock Waves - therapeutic use</subject><subject>Humans</subject><subject>Male</subject><subject>Metatarsal Bones - injuries</subject><subject>Middle Aged</subject><subject>Prospective Studies</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>1071-1007</issn><issn>1944-7876</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><recordid>eNp1kMtPAjEQhxujEUSPXk1vJiaLfbGlR4KgJPhIxHgyTelDwWWL7a6B_95uQG-eOul888vMB8A5Rl2KMb0eDyZdgjDuIs7yA9DGgrGM93l-mGrEcYYR4i1wEuMSIcwpFsegRQhiop-jNngbbaqgtA9rH6wq4POH15_wVX1bOEsf1cqWFfQOPvgygz7AG1uorTXwpVz4smk8Bb9ZrNLkva1UpUJM5TglVnWw8RQcOVVEe7Z_O2A2Hs2Gd9n08XYyHEwzTQmvsh5xlBmrNFY95ng6BynGiMGGKZHPc2SMpjl3XGkjUltQbJRyFOV9R7SgHXC5i10H_1XbWMnVImpbFKq0vo5SIEKJ6OU4kdmO1MHHGKyT65C2D1uJkWx8yuRTNj5l4zPxF_vker6y5o_-FZiAqx0Q1buVS1-HMh36T9oPbop9Fw</recordid><startdate>201108</startdate><enddate>201108</enddate><creator>Alvarez, Richard G.</creator><creator>Cincere, Brandon</creator><creator>Channappa, Chandra</creator><creator>Langerman, Richard</creator><creator>Schulte, Robert</creator><creator>Jaakkola, Juha</creator><creator>Melancon, Keith</creator><creator>Shereff, Michael</creator><creator>Lee Cross, G.</creator><general>SAGE Publications</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>7X8</scope></search><sort><creationdate>201108</creationdate><title>Extracorporeal Shock Wave Treatment of Non- or Delayed Union of Proximal Metatarsal Fractures</title><author>Alvarez, Richard G. ; Cincere, Brandon ; Channappa, Chandra ; Langerman, Richard ; Schulte, Robert ; Jaakkola, Juha ; Melancon, Keith ; Shereff, Michael ; Lee Cross, G.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c327t-52f34deac1a54f72010a442d1d4a96b60ddc367f7acd9720931daaf3068f2c93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Female</topic><topic>Fractures, Bone - therapy</topic><topic>Fractures, Ununited - therapy</topic><topic>Health Status Indicators</topic><topic>High-Energy Shock Waves - therapeutic use</topic><topic>Humans</topic><topic>Male</topic><topic>Metatarsal Bones - injuries</topic><topic>Middle Aged</topic><topic>Prospective Studies</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Alvarez, Richard G.</creatorcontrib><creatorcontrib>Cincere, Brandon</creatorcontrib><creatorcontrib>Channappa, Chandra</creatorcontrib><creatorcontrib>Langerman, Richard</creatorcontrib><creatorcontrib>Schulte, Robert</creatorcontrib><creatorcontrib>Jaakkola, Juha</creatorcontrib><creatorcontrib>Melancon, Keith</creatorcontrib><creatorcontrib>Shereff, Michael</creatorcontrib><creatorcontrib>Lee Cross, G.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Foot & ankle international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Alvarez, Richard G.</au><au>Cincere, Brandon</au><au>Channappa, Chandra</au><au>Langerman, Richard</au><au>Schulte, Robert</au><au>Jaakkola, Juha</au><au>Melancon, Keith</au><au>Shereff, Michael</au><au>Lee Cross, G.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Extracorporeal Shock Wave Treatment of Non- or Delayed Union of Proximal Metatarsal Fractures</atitle><jtitle>Foot & ankle international</jtitle><addtitle>Foot Ankle Int</addtitle><date>2011-08</date><risdate>2011</risdate><volume>32</volume><issue>8</issue><spage>746</spage><epage>754</epage><pages>746-754</pages><issn>1071-1007</issn><eissn>1944-7876</eissn><abstract>Background:
Nonunion or delayed union of fractures in the proximal aspect of metatarsals 1 to 4 and Zone 2 of the fifth metatarsal were treated by high energy extracorporeal shock wave treatment (ESWT) to study the safety and efficacy of this method of treatment in a FDA study of the Ossatron device.
Materials and Methods:
In a prospective single-arm, multi-center study, 34 fractures were treated in 32 patients (two subjects had two independent fractures) with ESWT. All fractures were at least 10 (range, 10 to 833) weeks after injury, with a median of 23 weeks. ESWT application was conducted using a protocol totaling 2,000 shocks for a total energy application of approximately 0.22 to 0.51 mJ/mm2 per treatment. The mean ESWT application time for each of the treatments was 24.6 ± 16.6 minutes, and anesthesia time averaged 27.1 ± 10.4 minutes. All subjects were followed for 1 year after treatment at intervals of 12 weeks, 6, 9, and 12 months.
Results:
The overall success rate at the 12-week visit was 71% with low complications, significant pain improvement as well as improvement on the SF-36. The success/fail criteria was evaluated again at the 6- and 12-month followup, showing treatment success rates of 89% (23/26) and 90% (18/20), respectively. The most common adverse event was swelling in the foot, reported by five subjects (15.6%).
Conclusion:
High-energy ESWT appears to be effective and safe in patients for treatment of nonunion or a delayed healing of a proximal metatarsal, and in fifth metatarsal fractures in Zone 2.
Level of Evidence: IV, Retrospective Case Series</abstract><cop>Los Angeles, CA</cop><pub>SAGE Publications</pub><pmid>22049860</pmid><doi>10.3113/FAI.2011.0746</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1071-1007 |
| ispartof | Foot & ankle international, 2011-08, Vol.32 (8), p.746-754 |
| issn | 1071-1007 1944-7876 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_902329561 |
| source | SAGE |
| subjects | Adolescent Adult Aged Female Fractures, Bone - therapy Fractures, Ununited - therapy Health Status Indicators High-Energy Shock Waves - therapeutic use Humans Male Metatarsal Bones - injuries Middle Aged Prospective Studies Treatment Outcome Young Adult |
| title | Extracorporeal Shock Wave Treatment of Non- or Delayed Union of Proximal Metatarsal Fractures |
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