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

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          Abstract

          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.

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          Most cited references24

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          EuroQol: the current state of play.

          R. Brooks (1996)
          The EuroQol Group first met in 1987 to test the feasibility of jointly developing a standardised non-disease-specific instrument for describing and valuing health-related quality of life. From the outset the Group has been multi-country, multi-centre, and multi-disciplinary. The EuroQol instrument is intended to complement other forms of quality of life measures, and it has been purposefully developed to generate a cardinal index of health, thus giving it considerable potential for use in economic evaluation. Considerable effort has been invested by the Group in the development and valuation aspects of health status measurement. Earlier work was reported upon in 1990; this paper is a second 'corporate' effort detailing subsequent developments. The concepts underlying the EuroQol framework are explored with particular reference to the generic nature of the instrument. The valuation task is reviewed and some evidence on the methodological requirements for measurement is presented. A number of special issues of considerable interest and concern to the Group are discussed: the modelling of data, the duration of health states and the problems surrounding the state 'dead'. An outline of some of the applications of the EuroQol instrument is presented and a brief commentary on the Group's ongoing programme of work concludes the paper.
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            Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes.

            Four rating systems were developed by the American Orthopaedic Foot and Ankle Society to provide a standard method of reporting clinical status of the ankle and foot. The systems incorporate both subjective and objective factors into numerical scales to describe function, alignment, and pain.
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              Assessment of the SF-36 version 2 in the United Kingdom.

              To introduce the UK SF36 Version II (SF36-II), and to (a) gain population norms for the UK SF36-II in a large community sample as well as to explore the instrument's internal consistency reliability and construct validity, and (b) to derive the Physical Component Summary (PCS) and Mental Component Summary (MCS) algorithms for the UK SF36-II. Postal survey using a questionnaire booklet, containing the SF-36-II and questions on demographics and long term illness. The sample was drawn from General Practitioner Records held by the Health Authorities for Berkshire, Buckinghamshire, Northamptonshire, and Oxfordshire. The questionnaire was sent to 13,800 randomly selected subjects between the ages of 18-64 inclusive. Scores for the eight dimensions of the UK SF36-II and the PCS and MCS summary scores. The survey achieved a response rate of 64.4% (n = 8889). Internal consistency of the different dimensions of the questionnaire were found to be high. Normative data for the SF-36 are reported, broken down by age and sex, and social class. Factor analysis of the eight domains produced a two factor solution and provided weights for the UK SF36-II. The SF36-II domains were shown to have improved reliability over the previous version of the UK SF36. Furthermore, enhancements to wording and response categories reduces the extent of floor and ceiling effects in the role performance dimensions. These advances are likely to lead to better precision as well as greater responsiveness in longitudinal studies.
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                Author and article information

                Contributors
                Role: professor of trauma and orthopaedic surgery
                Role: senior research fellow in medical statistics
                Role: associate professor in statistics
                Role: clinical research fellow
                Role: professor of clinical imaging
                Role: professor of epidemiology
                Role: professor of rehabilitation
                Journal
                BMJ
                BMJ
                bmj
                BMJ : British Medical Journal
                BMJ Publishing Group Ltd.
                0959-8138
                1756-1833
                2014
                24 July 2014
                : 349
                : g4483
                Affiliations
                [1 ]Warwick Medical School and Department of Statistics, University of Warwick, and University Hospital of Coventry and Warwickshire NHS Trust, Coventry, UK
                Author notes
                Correspondence to: D Griffin Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry CV4 7AL, UK damian.griffin@ 123456warwick.ac.uk
                Article
                grid017770
                10.1136/bmj.g4483
                4109620
                25059747
                c60ecf3b-7fb6-4fea-afd3-069cb5af016e
                © Griffin et al 2014

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/.

                History
                : 25 June 2014
                Categories
                Research

                Medicine
                Medicine

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