{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,26]],"date-time":"2026-10-26T18:04:50Z","timestamp":1793037890186,"version":"4.5.0"},"reference-count":32,"publisher":"BMJ","issue":"5","funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment Programme","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2019,4,1]]},"published-print":{"date-parts":[[2019,5]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>This feasibility study and process evaluation assessed the likely success of a definitive trial of intramedullary fixation with locked retrograde nails versus extramedullary fixation with fixed angle plates for fractures of the distal femur.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design &amp; setting<\/jats:title>\n                    <jats:p>A multicentre, parallel, two-arm, randomised controlled feasibility study with an embedded process evaluation was conducted at seven NHS hospitals in England. Treatment was randomly allocated in 1:1 ratio, stratified by centre and chronic cognitive impairment. Participants, but not surgeons or research staff, were blinded to the allocation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>Patients 18 years and older with a fracture of the distal femur, who their surgeon believed would benefit from internal fixation, were eligible to take part.Participants were allocated to receive either a retrograde intramedullary nail or an anatomical locking plate.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Outcomes<\/jats:title>\n                    <jats:p>The primary outcomes for this feasibility study were the recruitment rate and completion rate of the EQ-5D-5L at 4\u2009months post-randomisation. Baseline characteristics, disability rating index, quality of life scores, measurements of social support and self-efficacy, resource use and radiographic assessments were also collected. The views of patients and staff were collected during interviews.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Recruitment and data completion were lower than expected. 23 of 82 eligible patients were recruited (nail, 11; plate, 12). The recruitment rate was estimated as 0.42 (95% CI 0.27 to 0.62) participants per centre-month. Data completeness of the EQ-5D-5L at 4\u2009months was 61 per cent (95%\u2009CI 43% to 83%). The process evaluation demonstrated that the main barriers to recruitment were variation in treatment pathways across centres, lack of surgeon equipoise and confidence in using both interventions and newly formed research cultures that lacked cohesion.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>A modified trial design, with embedded recruitment support intervention, comparing functional outcome in cognitively intact adults who have sustained a fragility fracture of the distal femur is feasible.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics approval<\/jats:title>\n                    <jats:p>The Wales Research Ethics Committee 5 approved the study (ref: 16\/WA\/0225).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"ISRCTN92089567\" ext-link-type=\"isrctn\" specific-use=\"clinicaltrial pre-results\">ISRCTN92089567<\/jats:ext-link>\n                      ; Pre-results.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2018-026810","type":"journal-article","created":{"date-parts":[[2019,5,6]],"date-time":"2019-05-06T09:56:27Z","timestamp":1557136587000},"page":"e026810","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":22,"title":["Intramedullary nails versus distal locking plates for fracture of the distal femur: results from the Trial of Acute Femoral Fracture Fixation (TrAFFix) randomised feasibility study and process evaluation"],"prefix":"10.1136","volume":"9","clinical-trial-number":[{"clinical-trial-number":"isrctn92089567","registry":"10.18810\/isrctn","type":"preResults"}],"author":[{"given":"Xavier L","family":"Griffin","sequence":"first","affiliation":[{"name":"Oxford Trauma, University of Oxford Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, Oxford, UK"},{"name":"Oxford University Hospitals NHS Foundation Trust, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew L","family":"Costa","sequence":"additional","affiliation":[{"name":"Oxford Trauma, University of Oxford Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, Oxford, UK"},{"name":"Oxford University Hospitals NHS Foundation Trust, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emma","family":"Phelps","sequence":"additional","affiliation":[{"name":"Oxford Trauma, University of Oxford Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicholas","family":"Parsons","sequence":"additional","affiliation":[{"name":"Statistics and Epidemiology Unit, University of Warwick, Coventry, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melina","family":"Dritsaki","sequence":"additional","affiliation":[{"name":"Oxford Clinical Trials Research Unit, University of Oxford Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juul","family":"Achten","sequence":"additional","affiliation":[{"name":"Oxford Trauma, University of Oxford Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Tutton","sequence":"additional","affiliation":[{"name":"Oxford University Hospitals NHS Foundation Trust, Oxford, UK"},{"name":"Warwick Medical School, University of Warwick, Coventry, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8372-8181","authenticated-orcid":false,"given":"Robin Gillmore","family":"Lerner","sequence":"additional","affiliation":[{"name":"Kadoorie Centre, University of Oxford Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alwin","family":"McGibbon","sequence":"additional","affiliation":[{"name":"Patient and Public Representative, Coventry, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janis","family":"Baird","sequence":"additional","affiliation":[{"name":"MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK"},{"name":"NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2019,5,5]]},"reference":[{"key":"2025121600241542000_9.5.e026810.1","doi-asserted-by":"publisher","DOI":"10.1016\/j.injury.2006.04.130"},{"issue":"Suppl 3","key":"2025121600241542000_9.5.e026810.2","doi-asserted-by":"crossref","first-page":"62","DOI":"10.1016\/S0020-1383(00)80034-0","article-title":"The epidemiology of fractures of the distal femur","volume":"31","author":"Martinet","year":"2000","journal-title":"Injury"},{"key":"2025121600241542000_9.5.e026810.3","first-page":"CD010606","article-title":"Interventions for treating fractures of the distal femur in adults","volume":"8","author":"Griffin","year":"2015","journal-title":"Cochrane Database Syst Rev"},{"key":"2025121600241542000_9.5.e026810.4","unstructured":"Smith JRA , Morrison R , Yip G , et al . 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