{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T06:35:59Z","timestamp":1791959759699,"version":"4.3.4"},"reference-count":84,"publisher":"National Institute for Health and Care Research","issue":"05","license":[{"start":{"date-parts":[[2023,3,1]],"date-time":"2023-03-01T00:00:00Z","timestamp":1677628800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["12\/35\/27"],"award-info":[{"award-number":["12\/35\/27"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"<jats:sec id=\"abs1-1\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>We aimed to compare the clinical effectiveness, cost-effectiveness and complication rates of total ankle replacement with those of arthrodesis (i.e. ankle fusion) in the treatment of end-stage ankle osteoarthritis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-2\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This was a pragmatic, multicentre, parallel-group, non-blinded randomised controlled trial. Patients with end-stage ankle osteoarthritis who were aged 50\u201385 years and were suitable for both procedures were recruited from 17 UK hospitals and randomised using minimisation. The primary outcome was the change in the Manchester\u2013Oxford Foot Questionnaire walking\/standing domain scores between the preoperative baseline and 52 weeks post surgery.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-3\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Between March 2015 and January 2019, 303 participants were randomised using a minimisation algorithm: 152 to total ankle replacement and 151 to ankle fusion. At 52 weeks, the mean (standard deviation) Manchester\u2013Oxford Foot Questionnaire walking\/standing domain score was 31.4 (30.4) in the total ankle replacement arm (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009136) and 36.8 (30.6) in the ankle fusion arm (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009140); the adjusted difference in the change was \u20135.6 (95% confidence interval \u201312.5 to 1.4;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.12) in the intention-to-treat analysis. By week 52, one patient in the total ankle replacement arm required revision. Rates of wound-healing issues (13.4% vs. 5.7%) and nerve injuries (4.2% vs. &lt;\u20091%) were higher and the rate of thromboembolic events was lower (2.9% vs. 4.9%) in the total ankle replacement arm than in the ankle fusion arm. The bone non-union rate (based on plain radiographs) in the ankle fusion arm was 12.1%, but only 7.1% of patients had symptoms. A post hoc analysis of fixed-bearing total ankle replacement showed a statistically significant improvement over ankle fusion in Manchester\u2013Oxford Foot Questionnaire walking\/standing domain score (\u201311.1, 95% confidence interval \u201319.3 to \u20132.9;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.008). We estimate a 69% likelihood that total ankle replacement is cost-effective compared with ankle fusion at the National Institute for Health and Care Excellence\u2019s cost-effectiveness threshold of \u00a320,000 per quality-adjusted life-year gained over the patient\u2019s lifetime.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-4\">\n                    <jats:title>Limitations<\/jats:title>\n                    <jats:p>This initial report contains only 52-week data, which must therefore be interpreted with caution. In addition, the pragmatic nature of the study means that there was heterogeneity between surgical implants and techniques. The trial was run across 17 NHS centres to ensure that decision-making streams reflected the standard of care in the NHS as closely as possible.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-5\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Both total ankle replacement and ankle fusion improved patients\u2019 quality of life at 1 year, and both appear to be safe. When total ankle replacement was compared with ankle fusion overall, we were unable to show a statistically significant difference between the two arms in terms of our primary outcome measure. The total ankle replacement versus ankle arthrodesis (TARVA) trial is inconclusive in terms of superiority of total ankle replacement, as the 95% confidence interval for the adjusted treatment effect includes both a difference of zero and the minimal important difference of 12, but it can rule out the superiority of ankle fusion. A post hoc analysis comparing fixed-bearing total ankle replacement with ankle fusion showed a statistically significant improvement of total ankle replacement over ankle fusion in Manchester\u2013Oxford Foot Questionnaire walking\/standing domain score. Total ankle replacement appears to be cost-effective compared with ankle fusion at the National Institute for Health and Care Excellence\u2019s cost-effectiveness threshold of \u00a320,000 per quality-adjusted life-year gained over a patient\u2019s lifetime based on long-term economic modelling.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-6\">\n                    <jats:title>Future work<\/jats:title>\n                    <jats:p>We recommend long-term follow-up of this important cohort, in particular radiological and clinical progress. We also recommend studies to explore the sensitivity of clinical scores to detect clinically important differences between arms when both have already achieved a significant improvement from baseline.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-7\">\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>This trial is registered as ISRCTN60672307 and ClinicalTrials.gov NCT02128555.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-8\">\n                    <jats:title>Funding<\/jats:title>\n                    <jats:p>\n                      This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in\n                      <jats:italic>Health Technology Assessment<\/jats:italic>\n                      ; Vol. 27, No. 5. See the NIHR Journals Library website for further project information.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.3310\/ptyj1146","type":"journal-article","created":{"date-parts":[[2023,2,20]],"date-time":"2023-02-20T04:47:55Z","timestamp":1676868475000},"page":"1-80","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":35,"title":["Total ankle replacement versus ankle arthrodesis for patients aged 50\u201385 years with end-stage ankle osteoarthritis: the TARVA RCT"],"prefix":"10.3310","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8650-4503","authenticated-orcid":true,"given":"Andrew J","family":"Goldberg","sequence":"first","affiliation":[{"name":"Institute of Orthopaedics & Musculoskeletal Science, Division of Surgery, University College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8185-5152","authenticated-orcid":true,"given":"Kashfia","family":"Chowdhury","sequence":"additional","affiliation":[{"name":"Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3772-7049","authenticated-orcid":true,"given":"Ekaterina","family":"Bordea","sequence":"additional","affiliation":[{"name":"Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4335-5269","authenticated-orcid":true,"given":"James","family":"Blackstone","sequence":"additional","affiliation":[{"name":"Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deirdre","family":"Brooking","sequence":"additional","affiliation":[{"name":"Department of Research & Innovation, Royal National Orthopaedic Hospital, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1503-7768","authenticated-orcid":true,"given":"Elizabeth L","family":"Deane","sequence":"additional","affiliation":[{"name":"Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iva","family":"Hauptmannova","sequence":"additional","affiliation":[{"name":"Department of Research & Innovation, Royal National Orthopaedic Hospital, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Cooke","sequence":"additional","affiliation":[{"name":"Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Trust, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marion","family":"Cumbers","sequence":"additional","affiliation":[{"name":"Department of Research & Innovation, Royal National Orthopaedic Hospital, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7828-3122","authenticated-orcid":true,"given":"Simon S","family":"Skene","sequence":"additional","affiliation":[{"name":"Surrey Clinical Trials Unit, University of Surrey, Guildford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9796-4970","authenticated-orcid":true,"given":"Caroline J","family":"Dor\u00e9","sequence":"additional","affiliation":[{"name":"Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"6221","published-online":{"date-parts":[[2023,3]]},"reference":[{"key":"key2023032423583200_ref1-bib1","doi-asserted-by":"publisher","first-page":"2366","DOI":"10.2106\/JBJS.F.00295","article-title":"Impact of comorbidities on the measurement of health in patients with ankle osteoarthritis","volume":"88","author":"Saltzman","year":"2006","journal-title":"J Bone Joint Surg Am"},{"key":"key2023032423583200_ref2-bib2","doi-asserted-by":"publisher","first-page":"499","DOI":"10.2106\/JBJS.F.01299","article-title":"Comparison of health-related quality of life between patients with end-stage ankle and hip arthrosis","volume":"90","author":"Glazebrook","year":"2008","journal-title":"J Bone Joint Surg Am"},{"key":"key2023032423583200_ref3-bib3","doi-asserted-by":"publisher","first-page":"163","DOI":"10.1016\/j.foot.2012.02.005","article-title":"The demand incidence of symptomatic ankle osteoarthritis presenting to foot & ankle surgeons in the United Kingdom","volume":"22","author":"Goldberg","year":"2012","journal-title":"Foot"},{"key":"key2023032423583200_ref4-bib4","doi-asserted-by":"publisher","first-page":"440","DOI":"10.1002\/jor.23462","article-title":"Post-traumatic osteoarthritis of the ankle: a distinct clinical entity requiring new research approaches","volume":"35","author":"Delco","year":"2017","journal-title":"J Orthop Res"},{"key":"key2023032423583200_ref6-bib6","doi-asserted-by":"publisher","first-page":"155","DOI":"10.1097\/01.blo.0000038046.63743.c3","article-title":"Ankle fusion attributable to posttraumatic arthrosis: a long-term followup of 48 patients","volume":"406","author":"Buchner","year":"2003","journal-title":"Clin Orthop Relat Res"},{"key":"key2023032423583200_ref7-bib7","doi-asserted-by":"publisher","first-page":"994","DOI":"10.1302\/0301-620x.85b7.13984","article-title":"Quality of life 20 years after arthrodesis of the ankle. A study of adjacent joints","volume":"85","author":"Fuchs","year":"2003","journal-title":"J Bone Joint Surg Br"},{"key":"key2023032423583200_ref8-bib8","doi-asserted-by":"publisher","first-page":"33","DOI":"10.1097\/00003086-200110000-00006","article-title":"Complications of ankle and tibiotalocalcaneal arthrodesis","volume":"391","author":"Cooper","year":"2001","journal-title":"Clin Orthop Relat Res"},{"key":"key2023032423583200_ref9-bib9","doi-asserted-by":"publisher","first-page":"19","DOI":"10.1097\/01.blo.0000132243.41419.59","article-title":"Twenty-year evaluation of cementless mobile-bearing total ankle replacements","volume":"424","author":"Buechel","year":"2004","journal-title":"Clin Orthop Relat Res"},{"key":"key2023032423583200_ref10-bib10","doi-asserted-by":"publisher","first-page":"139","DOI":"10.1053\/j.jfas.2006.02.013","article-title":"Perioperative complications of the Agility total ankle replacement in 50 initial, consecutive cases","volume":"45","author":"Schuberth","year":"2006","journal-title":"J Foot Ankle Surg"},{"key":"key2023032423583200_ref11-bib11","doi-asserted-by":"publisher","first-page":"751","DOI":"10.2106\/JBJS.J.00178","article-title":"Heterotopic ossification after primary total ankle arthroplasty","volume":"93","author":"Lee","year":"2011","journal-title":"J Bone Joint Surg Am"},{"key":"key2023032423583200_ref12-bib12","doi-asserted-by":"publisher","first-page":"109","DOI":"10.1007\/s00402-004-0765-3","article-title":"Efficacy of total ankle replacement with meniscal-bearing devices: a systematic review and meta-analysis","volume":"125","author":"Stengel","year":"2005","journal-title":"Arch Orthop Trauma Surg"},{"key":"key2023032423583200_ref13-bib13","doi-asserted-by":"publisher","first-page":"1899","DOI":"10.2106\/00004623-200709000-00002","article-title":"Intermediate and long-term outcomes of total ankle arthroplasty and ankle arthrodesis. A systematic review of the literature","volume":"89","author":"Haddad","year":"2007","journal-title":"J Bone Joint Surg Am"},{"key":"key2023032423583200_ref14-bib14","doi-asserted-by":"publisher","first-page":"579","DOI":"10.3113\/FAI.2009.0579","article-title":"Prospective controlled trial of STAR total ankle replacement versus ankle fusion: initial results","volume":"30","author":"Saltzman","year":"2009","journal-title":"Foot Ankle Int"},{"key":"key2023032423583200_ref15-bib15","doi-asserted-by":"publisher","first-page":"199","DOI":"10.1007\/s11999-009-0987-3","article-title":"How successful are current ankle replacements?: a systematic review of the literature","volume":"468","author":"Gougoulias","year":"2010","journal-title":"Clin Orthop Relat Res"},{"key":"key2023032423583200_ref16-bib16","doi-asserted-by":"publisher","first-page":"563","DOI":"10.3113\/FAI.2010.0563","article-title":"Preference-based quality of life of end-stage ankle arthritis treated with arthroplasty or arthrodesis","volume":"31","author":"Slobogean","year":"2010","journal-title":"Foot Ankle Int"},{"key":"key2023032423583200_ref17-bib17","doi-asserted-by":"publisher","first-page":"383","DOI":"10.1053\/j.jfas.2011.03.004","article-title":"Comparative study of the quality of life between arthrodesis and total arthroplasty substitution of the ankle","volume":"50","author":"Esparragoza","year":"2011","journal-title":"J Foot Ankle Surg"},{"key":"key2023032423583200_ref18-bib18","doi-asserted-by":"publisher","first-page":"830","DOI":"10.2106\/JBJS.J.00103","article-title":"Impact of complications in total ankle replacement and ankle arthrodesis analyzed with a validated outcome measurement","volume":"93","author":"Krause","year":"2011","journal-title":"J Bone Joint Surg Am"},{"key":"key2023032423583200_ref19-bib19","doi-asserted-by":"publisher","first-page":"1647","DOI":"10.1007\/s00264-011-1336-1","article-title":"Arthroplasty versus arthrodesis for end-stage ankle arthritis: decision analysis using Markov model","volume":"35","author":"Kwon","year":"2011","journal-title":"Int Orthop"},{"key":"key2023032423583200_ref20-bib20","doi-asserted-by":"publisher","first-page":"135","DOI":"10.2106\/JBJS.L.01597","article-title":"Intermediate-term results of total ankle replacement and ankle arthrodesis: a COFAS multicenter study","volume":"96","author":"Daniels","year":"2014","journal-title":"J Bone Joint Surg Am"},{"key":"key2023032423583200_ref21-bib21","doi-asserted-by":"publisher","first-page":"1523","DOI":"10.2106\/JBJS.18.01012","article-title":"Outcomes of total ankle replacement, arthroscopic ankle arthrodesis, and open ankle arthrodesis for isolated non-deformed end-stage ankle arthritis","volume":"101","author":"Veljkovic","year":"2019","journal-title":"J Bone Joint Surg Am"},{"key":"key2023032423583200_ref22-bib22","unstructured":"National Joint Registry. 17th Annual Report: Surgical Data to 31 December 2019. 2020. URL: https:\/\/reports.njrcentre.org.uk\/Portals\/0\/PDFdownloads\/NJR%2017th%20Annual%20Report%202020.pdf (accessed 20 March 2021)."},{"key":"key2023032423583200_ref23-bib23","doi-asserted-by":"publisher","first-page":"1500","DOI":"10.1302\/0301-620X.95B11.31633","article-title":"The outcome of total ankle replacement: a systematic review and meta-analysis","volume":"95\u2013B","author":"Zaidi","year":"2013","journal-title":"Bone Joint J"},{"key":"key2023032423583200_ref24-bib24","doi-asserted-by":"publisher","first-page":"2143","DOI":"10.2106\/00004623-200710000-00007","article-title":"Comparison of reoperation rates following ankle arthrodesis and total ankle arthroplasty","volume":"89","author":"SooHoo","year":"2007","journal-title":"J Bone Joint Surg Am"},{"key":"key2023032423583200_ref25-bib25","doi-asserted-by":"publisher","first-page":"e012716","DOI":"10.1136\/bmjopen-2016-012716","article-title":"Total ankle replacement versus arthrodesis (TARVA): protocol for a multicentre randomised controlled trial","volume":"6","author":"Goldberg","year":"2016","journal-title":"BMJ Open"},{"key":"key2023032423583200_ref26-bib26","doi-asserted-by":"publisher","first-page":"197","DOI":"10.1186\/s13063-019-3973-4","article-title":"A randomised, multi-centre trial of total ankle replacement versus ankle arthrodesis in the treatment of patients with end stage ankle osteoarthritis (TARVA): statistical analysis plan","volume":"21","author":"Muller","year":"2020","journal-title":"Trials"},{"key":"key2023032423583200_ref27-bib27","doi-asserted-by":"publisher","first-page":"69","DOI":"10.4236\/ojrad.2020.102008","article-title":"MRI classification of subtalar joint osteoarthritis using a novel scoring system","volume":"10","author":"Zaidi","year":"2020","journal-title":"Open J Radiol"},{"key":"key2023032423583200_ref28-bib28","doi-asserted-by":"publisher","first-page":"868","DOI":"10.1177\/1071100716645391","article-title":"Validated method for measuring functional range of motion in patients with ankle arthritis","volume":"37","author":"Thornton","year":"2016","journal-title":"Foot Ankle Int"},{"key":"key2023032423583200_ref29-bib29","doi-asserted-by":"publisher","first-page":"713","DOI":"10.1177\/107110070502600909","article-title":"The surgical tibiotalar angle: a radiologic study","volume":"26","author":"Knupp","year":"2005","journal-title":"Foot Ankle Int"},{"key":"key2023032423583200_ref30-bib30","volume-title":"Common Terminology Criteria for Adverse Events (CTCAE)","author":"US Department of Health and Human Services, National Institutes of Health, National Cancer Institute","year":"2009"},{"key":"key2023032423583200_ref31-bib31","doi-asserted-by":"publisher","first-page":"1211","DOI":"10.1007\/s11136-006-0061-5","article-title":"A patient-based questionnaire to assess outcomes of foot surgery: validation in the context of surgery for hallux valgus","volume":"15","author":"Dawson","year":"2006","journal-title":"Qual Life Res"},{"key":"key2023032423583200_ref32-bib32","doi-asserted-by":"publisher","first-page":"215","DOI":"10.1302\/0301-620X.94B2.27634","article-title":"Responsiveness of the Manchester\u2013Oxford Foot Questionnaire (MOXFQ) compared with AOFAS, SF-36 and EQ-5D assessments following foot or ankle surgery","volume":"94","author":"Dawson","year":"2012","journal-title":"J Bone Joint Surg Br"},{"key":"key2023032423583200_ref33-bib33","volume-title":"User Manual for the Manchester Oxford Foot Questionnaire (MOXFQ)","author":"Morley","year":"2014"},{"key":"key2023032423583200_ref34-bib34","doi-asserted-by":"publisher","first-page":"968","DOI":"10.1177\/107110070502601113","article-title":"Evidence of validity for the Foot and Ankle Ability Measure (FAAM)","volume":"26","author":"Martin","year":"2005","journal-title":"Foot Ankle Int"},{"key":"key2023032423583200_ref35-bib35","volume-title":"EQ-5D-5L: About","author":"EuroQol","year":"2017"},{"key":"key2023032423583200_ref36-bib36","volume-title":"EQ-5D-5L User Guide: Basic Information on How to Use the EQ-5D-5L Instrument.","author":"van Reenen","year":"2015"},{"key":"key2023032423583200_ref37-bib37","doi-asserted-by":"publisher","first-page":"1095","DOI":"10.1097\/00005650-199711000-00002","article-title":"Modeling valuations for EuroQol health states","volume":"35","author":"Dolan","year":"1997","journal-title":"Med Care"},{"key":"key2023032423583200_ref38-bib38","doi-asserted-by":"publisher","first-page":"708","DOI":"10.1016\/j.jval.2012.02.008","article-title":"Interim scoring for the EQ-5D-5L: mapping the EQ-5D-5L to EQ-5D-3L value sets","volume":"15","author":"van Hout","year":"2012","journal-title":"Value Health"},{"key":"key2023032423583200_ref39-bib39","doi-asserted-by":"publisher","first-page":"271","DOI":"10.1016\/S0167-6296(01)00130-8","article-title":"The estimation of a preference-based measure of health from the SF-36","volume":"21","author":"Brazier","year":"2002","journal-title":"J Health Econ"},{"key":"key2023032423583200_ref40-bib40","doi-asserted-by":"publisher","first-page":"9","DOI":"10.1080\/17453674.2016.1181816","article-title":"Patient-reported outcome measures in arthroplasty registries. Report of the Patient-Reported Outcome Measures Working Group of the International Society of Arthroplasty Registries. Part II: recommendations for selection, administration, and analysis","volume":"87","author":"Rolfson","year":"2016","journal-title":"Acta Orthop"},{"key":"key2023032423583200_ref41-bib41","doi-asserted-by":"publisher","first-page":"357","DOI":"10.1302\/2058-5241.4.180080","article-title":"Orthopaedic registries with patient-reported outcome measures","volume":"4","author":"Wilson","year":"2019","journal-title":"EFORT Open Rev"},{"key":"key2023032423583200_ref42-bib42","doi-asserted-by":"publisher","first-page":"12","DOI":"10.1186\/1478-7547-7-12","article-title":"Comparing the performance of the EQ-5D and SF-6D when measuring the benefits of alleviating knee pain","volume":"7","author":"Barton","year":"2009","journal-title":"Cost Eff Resour Alloc"},{"key":"key2023032423583200_ref43-bib43","doi-asserted-by":"publisher","first-page":"110","DOI":"10.1186\/1477-7525-11-110","article-title":"Validity and responsiveness of EuroQol-5 dimension (EQ-5D) versus Short Form-6 dimension (SF-6D) questionnaire in chronic pain","volume":"11","author":"Obradovic","year":"2013","journal-title":"Health Qual Life Outcomes"},{"key":"key2023032423583200_ref44-bib44","doi-asserted-by":"publisher","first-page":"MS10","DOI":"10.1097\/00005650-199905001-00002","article-title":"The SF-36 Health Survey as a generic outcome measure in clinical trials of patients with osteoarthritis and rheumatoid arthritis: tests of data quality, scaling assumptions and score reliability","volume":"37","author":"Kosinski","year":"1999","journal-title":"Med Care"},{"key":"key2023032423583200_ref45-bib45","doi-asserted-by":"publisher","first-page":"459","DOI":"10.1007\/s11136-013-0517-3","article-title":"Probabilistic mapping of the health status measure SF-12 onto the health utility measure EQ-5D using the US-population-based scoring models","volume":"23","author":"Le","year":"2014","journal-title":"Qual Life Res"},{"key":"key2023032423583200_ref46-bib46","doi-asserted-by":"publisher","first-page":"918","DOI":"10.1016\/j.joca.2007.02.003","article-title":"Responsiveness and minimally important change for the Manchester\u2013Oxford foot questionnaire (MOXFQ) compared with AOFAS and SF-36 assessments following surgery for hallux valgus","volume":"15","author":"Dawson","year":"2007","journal-title":"Osteoarthritis Cartilage"},{"key":"key2023032423583200_ref47-bib47","doi-asserted-by":"publisher","first-page":"697","DOI":"10.1016\/j.jclinepi.2014.01.003","article-title":"Minimally important change was estimated for the Manchester\u2013Oxford Foot Questionnaire after foot\/ankle surgery","volume":"67","author":"Dawson","year":"2014","journal-title":"J Clin Epidemiol"},{"key":"key2023032423583200_ref48-bib48","doi-asserted-by":"publisher","first-page":"e2147","DOI":"10.1136\/bmj.e2147","article-title":"Total hip arthroplasty versus resurfacing arthroplasty in the treatment of patients with arthritis of the hip joint: single centre, parallel group, assessor blinded, randomised controlled trial","volume":"344","author":"Costa","year":"2012","journal-title":"BMJ"},{"key":"key2023032423583200_ref49-bib49","doi-asserted-by":"publisher","first-page":"2","DOI":"10.1186\/1745-6215-13-2","article-title":"Clustering in surgical trials \u2013 database of intracluster correlations","volume":"13","author":"Cook","year":"2012","journal-title":"Trials"},{"key":"key2023032423583200_ref50-bib50","volume-title":"Findings from the 2014\/15 Patient-Level Cost Collection","author":"NHS Improvement","year":"2016"},{"key":"key2023032423583200_ref51-bib51","volume-title":"Unit Costs of Health and Social Care 2019","author":"Curtis","year":"2019"},{"key":"key2023032423583200_ref52-bib52","volume-title":"NHS Reference Costs 2017\/18","author":"NHS Improvement"},{"key":"key2023032423583200_ref53-bib53","volume-title":"Unit Costs of Health and Social Care 2013","author":"Curtis","year":"2013"},{"key":"key2023032423583200_ref54-bib54","volume-title":"Unit Costs of Health and Social Care 2018","author":"Curtis","year":"2018"},{"key":"key2023032423583200_ref55-bib55","volume-title":"EARN08: Distribution of Gross Hourly Earnings of Employees","author":"Office for National Statistics","year":"2022"},{"key":"key2023032423583200_ref57-bib57","volume-title":"British National Formulary","author":"Joint Formulary Committee"},{"key":"key2023032423583200_ref58-bib58","doi-asserted-by":"publisher","first-page":"355","DOI":"10.1007\/s40273-014-0247-6","article-title":"An educational review of the statistical issues in analysing utility data for cost-utility analysis","volume":"33","author":"Hunter","year":"2015","journal-title":"PharmacoEconomics"},{"key":"key2023032423583200_ref59-bib59","doi-asserted-by":"publisher","first-page":"b2393","DOI":"10.1136\/bmj.b2393","article-title":"Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls","volume":"338","author":"Sterne","year":"2009","journal-title":"BMJ"},{"key":"key2023032423583200_ref60-bib60","doi-asserted-by":"publisher","first-page":"1721","DOI":"10.1007\/s11999-011-1848-4","article-title":"Is total ankle arthroplasty a cost-effective alternative to ankle fusion?","volume":"469","author":"Courville","year":"2011","journal-title":"Clin Orthop Relat Res"},{"key":"key2023032423583200_ref61-bib61","volume-title":"National Life Tables \u2013 Life Expectancy in the UK: 2017 to 2019","author":"Office for National Statistics","year":"2020"},{"key":"key2023032423583200_ref62-bib62","doi-asserted-by":"publisher","first-page":"2446","DOI":"10.2106\/00004623-200411000-00014","article-title":"Cost-effectiveness analysis of total ankle arthroplasty","volume":"86","author":"SooHoo","year":"2004","journal-title":"J Bone Joint Surg Am"},{"key":"key2023032423583200_ref63-bib63","volume-title":"Life Expectancy Calculator 2021","author":"Public Health England"},{"key":"key2023032423583200_ref65-bib65","doi-asserted-by":"publisher","DOI":"10.3310\/hta19140","article-title":"Methods for the estimation of the National Institute for Health and Care Excellence cost-effectiveness threshold","volume":"19","author":"Claxton","year":"2015","journal-title":"Health Technol Assess"},{"key":"key2023032423583200_ref66-bib66","doi-asserted-by":"publisher","first-page":"1485","DOI":"10.2106\/JBJS.18.01257","article-title":"Effectiveness and safety of ankle arthrodesis versus arthroplasty: a prospective multicenter study","volume":"101","author":"Norvell","year":"2019","journal-title":"J Bone Joint Surg Am"},{"key":"key2023032423583200_ref67-bib67","doi-asserted-by":"publisher","first-page":"490","DOI":"10.1302\/0301-620X.93B4.25731","article-title":"Venous thromboembolic events following foot and ankle surgery in the English National Health Service","volume":"93\u2013B","author":"Jameson","year":"2011","journal-title":"J Bone Joint Surg Br"},{"key":"key2023032423583200_ref68-bib68","doi-asserted-by":"publisher","first-page":"e011947","DOI":"10.1136\/bmjopen-2016-011947","article-title":"Pulmonary embolism and mortality following total ankle replacement: a data linkage study using the NJR data set","volume":"6","author":"Zaidi","year":"2016","journal-title":"BMJ Open"},{"key":"key2023032423583200_ref69-bib69","doi-asserted-by":"publisher","first-page":"945","DOI":"10.3113\/FAI.2009.0945","article-title":"Evidence-based classification of complications in total ankle arthroplasty","volume":"30","author":"Glazebrook","year":"2009","journal-title":"Foot Ankle Int"},{"key":"key2023032423583200_ref70-bib70","doi-asserted-by":"publisher","first-page":"434","DOI":"10.1177\/1071100714524549","article-title":"Assessment of a three-grade classification of complications in total ankle replacement","volume":"35","author":"Gadd","year":"2014","journal-title":"Foot Ankle Int"},{"key":"key2023032423583200_ref71-bib71","doi-asserted-by":"publisher","first-page":"560","DOI":"10.1080\/17453674.2018.1488208","article-title":"Re-arthrodesis after primary ankle fusion: 134\/1,716 cases from the Swedish Ankle Registry","volume":"89","author":"Henricson","year":"2018","journal-title":"Acta Orthop"},{"key":"key2023032423583200_ref72-bib72","doi-asserted-by":"publisher","first-page":"372","DOI":"10.1111\/os.12635","article-title":"Comparison of the efficiency and safety of total ankle replacement and ankle arthrodesis in the treatment of osteoarthritis: an updated systematic review and meta-analysis","volume":"12","author":"Li","year":"2020","journal-title":"Orthop Surg"},{"key":"key2023032423583200_ref73-bib73","doi-asserted-by":"publisher","first-page":"g4483","DOI":"10.1136\/bmj.g4483","article-title":"Operative versus non-operative treatment for closed, displaced, intra-articular fractures of the calcaneus: randomised controlled trial","volume":"349","author":"Griffin","year":"2014","journal-title":"BMJ"},{"key":"key2023032423583200_ref74-bib74","doi-asserted-by":"publisher","first-page":"310","DOI":"10.1302\/0301-620X.102B3.BJJ-2019-0723.R1","article-title":"The PAT randomized clinical trial","volume":"102\u2013B","author":"Joseph","year":"2020","journal-title":"Bone Joint J"},{"key":"key2023032423583200_ref75-bib75","doi-asserted-by":"publisher","first-page":"107","DOI":"10.1302\/0301-620X.99B1.BJJ-2016-0424.R1","article-title":"Effectiveness of open and arthroscopic rotator cuff repair (UKUFF): a randomised controlled trial","volume":"99\u2013B","author":"Carr","year":"2017","journal-title":"Bone Joint J"},{"key":"key2023032423583200_ref76-bib76","doi-asserted-by":"publisher","first-page":"e000752","DOI":"10.1136\/bmjopen-2011-000752","article-title":"The economic benefit of hip replacement: a 5-year follow-up of costs and outcomes in the Exeter Primary Outcomes Study","volume":"2","author":"Fordham","year":"2012","journal-title":"BMJ Open"},{"key":"key2023032423583200_ref77-bib77","doi-asserted-by":"publisher","first-page":"115","DOI":"10.1302\/0301-620X.95B1.29835","article-title":"Predicting the cost-effectiveness of total hip and knee replacement: a health economic analysis","volume":"95\u2013B","author":"Jenkins","year":"2013","journal-title":"Bone Joint J"},{"key":"key2023032423583200_ref78-bib78","doi-asserted-by":"publisher","first-page":"449","DOI":"10.1302\/0301-620X.97B4.34242","article-title":"Cost effectiveness of total hip arthroplasty in osteoarthritis","volume":"97\u2013B","author":"Pulikottil-Jacob","year":"2015","journal-title":"Bone Joint J"},{"key":"key2023032423583200_ref79-bib79","doi-asserted-by":"publisher","first-page":"e1001645","DOI":"10.1371\/journal.pmed.1001645","article-title":"Methods for specifying the target difference in a randomised controlled trial: the Difference ELicitation in TriAls (DELTA) systematic review","volume":"11","author":"Hislop","year":"2014","journal-title":"PLOS Med"},{"key":"key2023032423583200_ref80-bib80","doi-asserted-by":"publisher","first-page":"484","DOI":"10.1001\/archpsyc.63.5.484","article-title":"Caution regarding the use of pilot studies to guide power calculations for study proposals","volume":"63","author":"Kraemer","year":"2006","journal-title":"Arch Gen Psychiatry"},{"key":"key2023032423583200_ref81-bib81","volume-title":"Statistical Power Analysis for the Behavioral Sciences","author":"Cohen","year":"1977"},{"key":"key2023032423583200_ref82-bib82","doi-asserted-by":"publisher","first-page":"923","DOI":"10.1007\/s11136-009-9508-9","article-title":"Italian translation of the Manchester\u2013Oxford Foot Questionnaire, with re-assessment of reliability and validity","volume":"18","author":"Marinozzi","year":"2009","journal-title":"Qual Life Res"},{"key":"key2023032423583200_ref83-bib83","doi-asserted-by":"publisher","first-page":"92","DOI":"10.1016\/j.foot.2011.02.002","article-title":"The MOXFQ patient-reported questionnaire: assessment of data quality, reliability and validity in relation to foot and ankle surgery","volume":"21","author":"Dawson","year":"2011","journal-title":"Foot"},{"key":"key2023032423583200_ref84-bib84","doi-asserted-by":"publisher","first-page":"66","DOI":"10.1302\/2046-3758.24.2000147","article-title":"The Manchester\u2013Oxford Foot Questionnaire (MOXFQ) \u2013 development and validation of a summary index score","volume":"2","author":"Morley","year":"2013","journal-title":"Bone Joint Res"},{"key":"key2023032423583200_ref85-bib85","volume-title":"Methods for the Economic Evaluation of Health Care Programmes","author":"Drummond","year":"2015"},{"key":"key2023032423583200_ref86-bib86","volume-title":"Unit Costs of Health and Social Care 2010","author":"Curtis","year":"2010"},{"key":"key2023032423583200_ref87-bib87","volume-title":"Guidance: Advisory Fuel Rates","author":"Her Majesty\u2019s Revenue & Customs (HMRC)"}],"container-title":["Health Technology Assessment"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/njl-admin.nihr.ac.uk\/document\/download\/2042159","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.journalslibrary.nihr.ac.uk\/publications\/PTYJ1146\/PTYJ1146.xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/njl-admin.nihr.ac.uk\/document\/download\/2042159","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,15]],"date-time":"2023-08-15T11:40:33Z","timestamp":1692099633000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.journalslibrary.nihr.ac.uk\/hta\/PTYJ1146"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,3]]},"references-count":84,"journal-issue":{"issue":"05","published-online":{"date-parts":[[2023,3]]}},"alternative-id":["10.3310\/PTYJ1146"],"URL":"https:\/\/doi.org\/10.3310\/ptyj1146","relation":{},"ISSN":["1366-5278","2046-4924"],"issn-type":[{"value":"1366-5278","type":"print"},{"value":"2046-4924","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,3]]},"assertion":[{"value":"This content has been made freely available to all.","name":"free","label":"Free to read"},{"value":"11-2013","name":"contractual_start_date","label":"contractual_start_date","group":{"name":"article_history","label":"Article History"}},{"value":"04-2021","name":"editorial_review_begun","label":"editorial review begun","group":{"name":"article_history","label":"Article History"}},{"value":"02-2022","name":"accepted_for_publication","label":"Accepted for publication","group":{"name":"article_history","label":"Article History"}}]}}