Operative versus non-operative treatment for closed, displaced, intra-articular fractures of the calcaneus: randomised controlled trial

Objective To investigate whether surgery by open reduction and internal fixation provides benefit compared with non-operative treatment for displaced, intra-articular calcaneal fractures.Design Pragmatic, multicentre, two arm, parallel group, assessor blinded randomised controlled trial (UK Heel Fra...

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Veröffentlicht in:BMJ (Online) 2014-07, Vol.349 (jul24 5), p.g4483-g4483
Hauptverfasser: Griffin, Damian, Parsons, Nick, Shaw, Ewart, Kulikov, Yuri, Hutchinson, Charles, Thorogood, Margaret, Lamb, Sarah E
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container_end_page g4483
container_issue jul24 5
container_start_page g4483
container_title BMJ (Online)
container_volume 349
creator Griffin, Damian
Parsons, Nick
Shaw, Ewart
Kulikov, Yuri
Hutchinson, Charles
Thorogood, Margaret
Lamb, Sarah E
description Objective To investigate whether surgery by open reduction and internal fixation provides benefit compared with non-operative treatment for displaced, intra-articular calcaneal fractures.Design Pragmatic, multicentre, two arm, parallel group, assessor blinded randomised controlled trial (UK Heel Fracture Trial).Setting 22 tertiary referral hospitals, United Kingdom.Participants 151 patients with acute displaced intra-articular calcaneal fractures randomly allocated to operative (n=73) or non-operative (n=78) treatment.Main outcome measures The primary outcome measure was patient reported Kerr-Atkins score for pain and function (scale 0-100, 100 being the best possible score) at two years after injury. Secondary outcomes were complications; hindfoot pain and function (American Orthopaedic Foot and Ankle Society score); general health (SF-36); quality of life (EQ-5D); clinical examination; walking speed; and gait symmetry. Analysis was by intention to treat.Results 95% follow-up was achieved for the primary outcome (69 in operative group and 74 in non-operative group), and a complete set of secondary outcomes were available for 75% of participants. There was no significant difference in the primary outcome (mean Kerr-Atkins score 69.8 in operative group v 65.7 in non-operative group; adjusted 95% confidence interval of difference −7.1 to 7.0) or in any of the secondary outcomes between treatment groups. Complications and reoperations were more common in those who received operative care (estimated odds ratio 7.5, 95% confidence interval 2.0 to 41.8).Conclusions Operative treatment compared with non-operative care showed no symptomatic or functional advantage after two years in patients with typical displaced intra-articular fractures of the calcaneus, and the risk of complications was higher after surgery. Based on these findings, operative treatment by open reduction and internal fixation is not recommended for these fractures.Trial registration Current Controlled Trials ISRCTN37188541.
doi_str_mv 10.1136/bmj.g4483
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Secondary outcomes were complications; hindfoot pain and function (American Orthopaedic Foot and Ankle Society score); general health (SF-36); quality of life (EQ-5D); clinical examination; walking speed; and gait symmetry. Analysis was by intention to treat.Results 95% follow-up was achieved for the primary outcome (69 in operative group and 74 in non-operative group), and a complete set of secondary outcomes were available for 75% of participants. There was no significant difference in the primary outcome (mean Kerr-Atkins score 69.8 in operative group v 65.7 in non-operative group; adjusted 95% confidence interval of difference −7.1 to 7.0) or in any of the secondary outcomes between treatment groups. Complications and reoperations were more common in those who received operative care (estimated odds ratio 7.5, 95% confidence interval 2.0 to 41.8).Conclusions Operative treatment compared with non-operative care showed no symptomatic or functional advantage after two years in patients with typical displaced intra-articular fractures of the calcaneus, and the risk of complications was higher after surgery. Based on these findings, operative treatment by open reduction and internal fixation is not recommended for these fractures.Trial registration Current Controlled Trials ISRCTN37188541.</description><identifier>ISSN: 0959-8138</identifier><identifier>ISSN: 1756-1833</identifier><identifier>EISSN: 1756-1833</identifier><identifier>DOI: 10.1136/bmj.g4483</identifier><identifier>PMID: 25059747</identifier><language>eng</language><publisher>England: British Medical Journal Publishing Group</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Ankle ; Calcaneus - injuries ; Developing countries ; Emergency medical care ; Female ; Fracture Fixation - methods ; Fracture Fixation - rehabilitation ; Fracture Fixation, Internal - methods ; Fracture Fixation, Internal - rehabilitation ; Fractures ; Fractures, Bone - physiopathology ; Fractures, Bone - rehabilitation ; Fractures, Bone - therapy ; Fractures, Closed - physiopathology ; Fractures, Closed - rehabilitation ; Fractures, Closed - therapy ; Hospitals ; Humans ; Injuries ; Intra-Articular Fractures - physiopathology ; Intra-Articular Fractures - rehabilitation ; Intra-Articular Fractures - therapy ; LDCs ; Male ; Middle Aged ; Orthopedics ; Pain, Postoperative - etiology ; Patient Compliance ; Patients ; Physical therapy ; Physical Therapy Modalities ; Pilot Projects ; Range of Motion, Articular ; Recovery of Function - physiology ; Reoperation - psychology ; Surgeons ; Surgery ; Tomography ; Treatment Outcome ; Young Adult</subject><ispartof>BMJ (Online), 2014-07, Vol.349 (jul24 5), p.g4483-g4483</ispartof><rights>Griffin et al 2014</rights><rights>Griffin et al 2014.</rights><rights>Copyright BMJ Publishing Group LTD Jul 24, 2014</rights><rights>Griffin et al 2014 2014 Griffin et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b454t-c9b8fcfaaa56d786744b61758b6da8607ce805e09393d3b7adda3791283f44903</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttp://bmj.com/content/349/bmj.g4483.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttp://bmj.com/content/349/bmj.g4483.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>114,115,230,314,777,781,800,882,3183,23552,27905,27906,57998,58231,77349,77380</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25059747$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Griffin, Damian</creatorcontrib><creatorcontrib>Parsons, Nick</creatorcontrib><creatorcontrib>Shaw, Ewart</creatorcontrib><creatorcontrib>Kulikov, Yuri</creatorcontrib><creatorcontrib>Hutchinson, Charles</creatorcontrib><creatorcontrib>Thorogood, Margaret</creatorcontrib><creatorcontrib>Lamb, Sarah E</creatorcontrib><creatorcontrib>UK Heel Fracture Trial Investigators</creatorcontrib><creatorcontrib>for the UK Heel Fracture Trial (UK HeFT) investigators</creatorcontrib><title>Operative versus non-operative treatment for closed, displaced, intra-articular fractures of the calcaneus: randomised controlled trial</title><title>BMJ (Online)</title><addtitle>BMJ</addtitle><description>Objective To investigate whether surgery by open reduction and internal fixation provides benefit compared with non-operative treatment for displaced, intra-articular calcaneal fractures.Design Pragmatic, multicentre, two arm, parallel group, assessor blinded randomised controlled trial (UK Heel Fracture Trial).Setting 22 tertiary referral hospitals, United Kingdom.Participants 151 patients with acute displaced intra-articular calcaneal fractures randomly allocated to operative (n=73) or non-operative (n=78) treatment.Main outcome measures The primary outcome measure was patient reported Kerr-Atkins score for pain and function (scale 0-100, 100 being the best possible score) at two years after injury. Secondary outcomes were complications; hindfoot pain and function (American Orthopaedic Foot and Ankle Society score); general health (SF-36); quality of life (EQ-5D); clinical examination; walking speed; and gait symmetry. Analysis was by intention to treat.Results 95% follow-up was achieved for the primary outcome (69 in operative group and 74 in non-operative group), and a complete set of secondary outcomes were available for 75% of participants. There was no significant difference in the primary outcome (mean Kerr-Atkins score 69.8 in operative group v 65.7 in non-operative group; adjusted 95% confidence interval of difference −7.1 to 7.0) or in any of the secondary outcomes between treatment groups. Complications and reoperations were more common in those who received operative care (estimated odds ratio 7.5, 95% confidence interval 2.0 to 41.8).Conclusions Operative treatment compared with non-operative care showed no symptomatic or functional advantage after two years in patients with typical displaced intra-articular fractures of the calcaneus, and the risk of complications was higher after surgery. 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Parsons, Nick ; Shaw, Ewart ; Kulikov, Yuri ; Hutchinson, Charles ; Thorogood, Margaret ; Lamb, Sarah E</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b454t-c9b8fcfaaa56d786744b61758b6da8607ce805e09393d3b7adda3791283f44903</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Ankle</topic><topic>Calcaneus - injuries</topic><topic>Developing countries</topic><topic>Emergency medical care</topic><topic>Female</topic><topic>Fracture Fixation - methods</topic><topic>Fracture Fixation - rehabilitation</topic><topic>Fracture Fixation, Internal - methods</topic><topic>Fracture Fixation, Internal - rehabilitation</topic><topic>Fractures</topic><topic>Fractures, Bone - physiopathology</topic><topic>Fractures, Bone - rehabilitation</topic><topic>Fractures, Bone - therapy</topic><topic>Fractures, Closed - physiopathology</topic><topic>Fractures, Closed - rehabilitation</topic><topic>Fractures, Closed - therapy</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Injuries</topic><topic>Intra-Articular Fractures - physiopathology</topic><topic>Intra-Articular Fractures - rehabilitation</topic><topic>Intra-Articular Fractures - therapy</topic><topic>LDCs</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Orthopedics</topic><topic>Pain, Postoperative - etiology</topic><topic>Patient Compliance</topic><topic>Patients</topic><topic>Physical therapy</topic><topic>Physical Therapy Modalities</topic><topic>Pilot Projects</topic><topic>Range of Motion, Articular</topic><topic>Recovery of Function - physiology</topic><topic>Reoperation - psychology</topic><topic>Surgeons</topic><topic>Surgery</topic><topic>Tomography</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Griffin, Damian</creatorcontrib><creatorcontrib>Parsons, Nick</creatorcontrib><creatorcontrib>Shaw, Ewart</creatorcontrib><creatorcontrib>Kulikov, Yuri</creatorcontrib><creatorcontrib>Hutchinson, Charles</creatorcontrib><creatorcontrib>Thorogood, Margaret</creatorcontrib><creatorcontrib>Lamb, Sarah E</creatorcontrib><creatorcontrib>UK Heel Fracture Trial Investigators</creatorcontrib><creatorcontrib>for the UK Heel Fracture Trial (UK HeFT) investigators</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><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>Nursing &amp; 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Secondary outcomes were complications; hindfoot pain and function (American Orthopaedic Foot and Ankle Society score); general health (SF-36); quality of life (EQ-5D); clinical examination; walking speed; and gait symmetry. Analysis was by intention to treat.Results 95% follow-up was achieved for the primary outcome (69 in operative group and 74 in non-operative group), and a complete set of secondary outcomes were available for 75% of participants. There was no significant difference in the primary outcome (mean Kerr-Atkins score 69.8 in operative group v 65.7 in non-operative group; adjusted 95% confidence interval of difference −7.1 to 7.0) or in any of the secondary outcomes between treatment groups. Complications and reoperations were more common in those who received operative care (estimated odds ratio 7.5, 95% confidence interval 2.0 to 41.8).Conclusions Operative treatment compared with non-operative care showed no symptomatic or functional advantage after two years in patients with typical displaced intra-articular fractures of the calcaneus, and the risk of complications was higher after surgery. Based on these findings, operative treatment by open reduction and internal fixation is not recommended for these fractures.Trial registration Current Controlled Trials ISRCTN37188541.</abstract><cop>England</cop><pub>British Medical Journal Publishing Group</pub><pmid>25059747</pmid><doi>10.1136/bmj.g4483</doi><oa>free_for_read</oa></addata></record>
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source MEDLINE; BMJ Journals - NESLi2; Jstor Complete Legacy
subjects Adolescent
Adult
Aged
Aged, 80 and over
Ankle
Calcaneus - injuries
Developing countries
Emergency medical care
Female
Fracture Fixation - methods
Fracture Fixation - rehabilitation
Fracture Fixation, Internal - methods
Fracture Fixation, Internal - rehabilitation
Fractures
Fractures, Bone - physiopathology
Fractures, Bone - rehabilitation
Fractures, Bone - therapy
Fractures, Closed - physiopathology
Fractures, Closed - rehabilitation
Fractures, Closed - therapy
Hospitals
Humans
Injuries
Intra-Articular Fractures - physiopathology
Intra-Articular Fractures - rehabilitation
Intra-Articular Fractures - therapy
LDCs
Male
Middle Aged
Orthopedics
Pain, Postoperative - etiology
Patient Compliance
Patients
Physical therapy
Physical Therapy Modalities
Pilot Projects
Range of Motion, Articular
Recovery of Function - physiology
Reoperation - psychology
Surgeons
Surgery
Tomography
Treatment Outcome
Young Adult
title Operative versus non-operative treatment for closed, displaced, intra-articular fractures of the calcaneus: randomised controlled trial
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