{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T07:09:57Z","timestamp":1788851397999,"version":"build-2803163510"},"reference-count":24,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T00:00:00Z","timestamp":1777593600000},"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":["NIHR131118"],"award-info":[{"award-number":["NIHR131118"]}],"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":"\n Background<\/jats:title>\n Fractures of the cervical spine\u2019s odontoid process can result from low-impact falls in frail or older adults, and are usually managed in hard collars to immobilise the fracture and promote bony healing. However, bony healing often does not occur in older\/frail adults and is not necessary for good outcomes. Further, hard collars can cause complications, such as skin pressure ulcers, and difficulties with swallowing or personal care.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To examine whether management of odontoid process fractures without hard collar immobilisation is associated with improved quality of life in older\/frail patients.<\/jats:p>\n <\/jats:sec>\n \n Design and methods<\/jats:title>\n The Duration of External Neck Stabilisation trial was a non-blinded randomised controlled trial with a nested qualitative study.<\/jats:p>\n <\/jats:sec>\n \n Setting and participants<\/jats:title>\n Aimed to recruit 887 participants from 25 United Kingdom hospitals, over 2 years. Eligible patients were aged \u2265\u200565 years, or with Rockwood Clinical Frailty Scale of \u2265\u20055.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Comparing early hard collar removal (intervention) with standard management in a hard collar for 12 weeks.<\/jats:p>\n <\/jats:sec>\n \n Main outcome measures<\/jats:title>\n Primary outcome measure: quality of life 12 weeks following randomisation. EuroQol-5 Dimensions, five-level version.<\/jats:p>\n <\/jats:sec>\n \n Randomisation<\/jats:title>\n Web-based randomisation system based on age, fracture type and frailty.<\/jats:p>\n <\/jats:sec>\n \n Blinding<\/jats:title>\n Participants not blinded. Outcome event adjudication committee blinded to treatment allocation.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n The study was terminated prematurely because of slow recruitment. One hundred and thirty-eight patients were randomised with. 83.3% aged >\u200575 years old and. 72.5% of fractures being odontoid type 2. Mean number of days in collar 0.2 (standard deviation 1.4) for early removal of collar participants, and 55.5 days (standard deviation 38.0) for standard management participants; 15.6% of standard management participants crossed over, 3.0% of early removal of collar participants. Twenty-eight days after randomisation, 80 patients (61.5%) were not wearing a collar.<\/jats:p>\n \n Primary end-point assessment (EuroQol 5 dimension instrument five-level version at 12 weeks), based on intention-to-treat analysis, mean score 0.650 (standard error 0.039, 0.490 to 0.86) in early removal of collar group and 0.0667 (standard error 0.040, 0.51 to 0.89) in standard management group. Pre-specified subgroup analysis by fracture type (\n p<\/jats:italic>\n \u2005=\u20050.3645), Rockwood score (\n p<\/jats:italic>\n \u2005=\u20050.6593) and age (\n p<\/jats:italic>\n \u2005=\u20050.4088) were non-significant. Qualitative study participants reported decreased autonomy following the fracture. Standard management patients reported additional negative impacts. There was need for better information about the injury, \u2018normal\u2019 recovery and return to activities.\n <\/jats:p>\n \n Seventeen patients died; 10 (17.2%) early removal of collar group, 7 (9.8%) standard management group [odds ratio\u2005=\u20051.92 (95% confidence interval 0.61 to 6.04),\n p<\/jats:italic>\n \u2005=\u20050.266]. No deaths directly related to fracture or trial allocation.\n <\/jats:p>\n <\/jats:sec>\n \n Limitations<\/jats:title>\n The study opened in 2021, during the COVID-19 pandemic. The recruited population is underpowered considering the planned sample size. The qualitative analysis revealed several obstacles to trial recruitment, including loss of equipoise.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n Clinicians should consider prioritising independence and comfort of older\/frail patients with odontoid fracture by early collar removal. This study supports that this can be achieved without a clear detriment to the patient.<\/jats:p>\n <\/jats:sec>\n \n Future work<\/jats:title>\n There is not likely equipoise for a further randomised trial, even if measures could be considered to enhance recruitment. Instead, future prospective observational studies would be well placed to confirm and extend our findings.<\/jats:p>\n <\/jats:sec>\n \n Funding<\/jats:title>\n This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR131118.<\/jats:p>\n <\/jats:sec>","DOI":"10.3310\/gjpb0728","type":"journal-article","created":{"date-parts":[[2025,7,28]],"date-time":"2025-07-28T08:07:58Z","timestamp":1753690078000},"page":"1-36","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Duration of external neck stabilisation in the management of older and frail patients with a new odontoid fracture: the DENS RCT"],"prefix":"10.3310","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7347-830X","authenticated-orcid":true,"given":"Paul M","family":"Brennan","sequence":"first","affiliation":[{"name":"Translational Neurosurgery, Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-9938-0719","authenticated-orcid":true,"given":"Marta","family":"Adamczyk","sequence":"additional","affiliation":[{"name":"Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4642-8745","authenticated-orcid":true,"given":"Mia","family":"Closs","sequence":"additional","affiliation":[{"name":"Usher Institute, University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0706-6902","authenticated-orcid":true,"given":"Phillip","family":"Copley","sequence":"additional","affiliation":[{"name":"Department of Clinical Neurosciences, Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4479-6034","authenticated-orcid":true,"given":"Gina","family":"Cranswick","sequence":"additional","affiliation":[{"name":"Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6023-3661","authenticated-orcid":true,"given":"Helen","family":"Eborall","sequence":"additional","affiliation":[{"name":"Usher Institute, University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7253-9115","authenticated-orcid":true,"given":"Ellie","family":"Edlmann","sequence":"additional","affiliation":[{"name":"Peninsula Medical School, University of Plymouth, Plymouth, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5459-6178","authenticated-orcid":true,"given":"Catriona","family":"Keerie","sequence":"additional","affiliation":[{"name":"Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4667-9763","authenticated-orcid":true,"given":"Kat","family":"Oatey","sequence":"additional","affiliation":[{"name":"Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7492-962X","authenticated-orcid":true,"given":"Sadaquate","family":"Khan","sequence":"additional","affiliation":[{"name":"Department of Clinical Neurosciences, Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8016-7374","authenticated-orcid":true,"given":"Julia","family":"Lawton","sequence":"additional","affiliation":[{"name":"Usher Institute, University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4866-2049","authenticated-orcid":true,"given":"David","family":"Lowe","sequence":"additional","affiliation":[{"name":"School of Health and Well Being, University of Glasgow, Glasgow, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9823-9252","authenticated-orcid":true,"given":"John","family":"Norrie","sequence":"additional","affiliation":[{"name":"Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5886-0220","authenticated-orcid":true,"given":"Angela","family":"Niven","sequence":"additional","affiliation":[{"name":"Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5839-3191","authenticated-orcid":true,"given":"Philip","family":"Rayson","sequence":"additional","affiliation":[{"name":"Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1308-4824","authenticated-orcid":true,"given":"Matthew","family":"Reed","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine, Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1352-3922","authenticated-orcid":true,"given":"Aryelly","family":"Rodriguez","sequence":"additional","affiliation":[{"name":"Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bea","family":"Selby","sequence":"additional","affiliation":[{"name":"Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2252-9461","authenticated-orcid":true,"given":"Himanshu","family":"Shekhar","sequence":"additional","affiliation":[{"name":"Ninewells Hospital, NHS, Tayside, Dundee"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7375-4776","authenticated-orcid":true,"given":"Susan","family":"Shenkin","sequence":"additional","affiliation":[{"name":"Usher Institute, College of Medicine and Veterinary Medicine, University of, Edinburgh, Edinburgh"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pina","family":"Sorbara","sequence":"additional","affiliation":[{"name":"Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5604-3312","authenticated-orcid":true,"given":"Patrick","family":"Statham","sequence":"additional","affiliation":[{"name":"Department of Clinical Neurosciences, Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1958-3897","authenticated-orcid":true,"given":"Andrew","family":"Stoddart","sequence":"additional","affiliation":[{"name":"Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0990-0254","authenticated-orcid":true,"given":"James","family":"Tomlinson","sequence":"additional","affiliation":[{"name":"Department of Orthopaedics, Sheffield Teaching Hospital, NHS Foundation Trust, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-5780-3422","authenticated-orcid":true,"given":"Jennifer","family":"Waddell","sequence":"additional","affiliation":[{"name":"Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3645-500X","authenticated-orcid":true,"given":"Julie","family":"Woodfield","sequence":"additional","affiliation":[{"name":"Department of Clinical Neurosciences, Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"6221","published-online":{"date-parts":[[2026,5]]},"reference":[{"key":"key2026090807023400_ref1-bib1","doi-asserted-by":"crossref","first-page":"e057753","DOI":"10.1136\/bmjopen-2021-057753","article-title":"Duration of external neck stabilisation (DENS) following odontoid fracture in older or frail adults: protocol for a randomised controlled trial of collar versus no collar","volume":"12","author":"Woodfield","year":"2022","journal-title":"BMJ Open"},{"key":"key2026090807023400_ref2-bib2","volume-title":"Falls: Applying All Our Health","author":"GOV.UK"},{"key":"key2026090807023400_ref3-bib3","doi-asserted-by":"crossref","first-page":"2036","DOI":"10.1111\/jgs.13670","article-title":"Mortality and readmission after cervical fracture from a fall in older adults: comparison with hip fracture using National Medicare Data","volume":"63","author":"Cooper","year":"2015","journal-title":"J Am Geriatr Soc"},{"key":"key2026090807023400_ref4-bib4","doi-asserted-by":"crossref","first-page":"E648","DOI":"10.1093\/neuros\/nyaa256","article-title":"Conservative management of type II odontoid fractures in older people: a retrospective observational comparison of osseous union versus nonunion","volume":"87","author":"McIlroy","year":"2020","journal-title":"Neurosurgery"},{"key":"key2026090807023400_ref5-bib5","doi-asserted-by":"crossref","first-page":"951","DOI":"10.1097\/BRS.0000000000002982","article-title":"Functional outcome of elderly patients treated for odontoid fracture: a multicenter study","volume":"44","author":"De Bonis","year":"2019","journal-title":"Spine"},{"key":"key2026090807023400_ref6-bib6","doi-asserted-by":"crossref","first-page":"195","DOI":"10.1007\/s00586-010-1507-6","article-title":"Type II odontoid fractures in the elderly: an evidence-based narrative review of management","volume":"20","author":"Pal","year":"2011","journal-title":"Eur Spine J"},{"key":"key2026090807023400_ref7-bib7","doi-asserted-by":"crossref","first-page":"1064","DOI":"10.1007\/s00586-019-05898-2","article-title":"Type II odontoid fracture in elderly patients treated conservatively: is fracture healing the goal?","volume":"28","author":"Lofrese","year":"2019","journal-title":"Eur Spine J"},{"key":"key2026090807023400_ref8-bib8","volume-title":"Progressive Myelopathy Secondary to Odontoid Fractures: Clinical, Radiological, and Surgical Features","author":"Crockard","year":"1993"},{"key":"key2026090807023400_ref9-bib9","doi-asserted-by":"crossref","first-page":"286","DOI":"10.1080\/02688697.2018.1445828","article-title":"Cervical spine immobilisation in the elderly: a literature review","volume":"32","author":"Peck","year":"2018","journal-title":"Br J Neurosurg"},{"key":"key2026090807023400_ref10-bib10","doi-asserted-by":"crossref","first-page":"199","DOI":"10.1016\/0168-8510(90)90421-9","article-title":"EuroQol: a new facility for the measurement of health-related quality of life","volume":"16","author":"EuroQol Group","year":"1990","journal-title":"Health Policy"},{"key":"key2026090807023400_ref11-bib11","first-page":"409","article-title":"The Neck Disability Index: a study of reliability and validity","volume":"14","author":"Vernon","year":"1991","journal-title":"J Manipulative Physiol Ther"},{"key":"key2026090807023400_ref12-bib12","doi-asserted-by":"crossref","first-page":"489","DOI":"10.1503\/cmaj.050051","article-title":"A global clinical measure of fitness and frailty in elderly people","volume":"173","author":"Rockwood","year":"2005","journal-title":"Canad Med Assoc J"},{"key":"key2026090807023400_ref13-bib13","doi-asserted-by":"crossref","first-page":"1663","DOI":"10.2106\/00004623-197456080-00017","article-title":"Fractures of the odontoid process of the axis","volume":"56","author":"Anderson","year":"1974","journal-title":"J Bone Joint Surg Am"},{"key":"key2026090807023400_ref14-bib14","doi-asserted-by":"crossref","first-page":"1663","DOI":"10.2106\/00004623-197456080-00017","article-title":"Fractures of the odontoid process of the axis","volume":"56","author":"Anderson","year":"1974","journal-title":"J Bone Joint Surg Am."},{"key":"key2026090807023400_ref15-bib15","doi-asserted-by":"crossref","first-page":"419","DOI":"10.1093\/neuros\/nyx546","article-title":"Management of odontoid fractures in the elderly: a review of the literature and an evidence-based treatment algorithm","volume":"82","author":"Iyer","year":"2018","journal-title":"Neurosurgery"},{"key":"key2026090807023400_ref16-bib16","doi-asserted-by":"crossref","first-page":"1024","DOI":"10.1002\/hec.3654","article-title":"Missing data in trial-based cost-effectiveness analysis: an incomplete journey","volume":"27","author":"Leurent","year":"2018","journal-title":"Health Econ"},{"key":"key2026090807023400_ref17-bib17","doi-asserted-by":"crossref","first-page":"199","DOI":"10.1007\/s40273-022-01218-7","article-title":"Estimating the relationship between EQ-5D-5L and EQ-5D-3L: results from a UK population study","volume":"41","author":"Hern\u00e1ndez Alava","year":"2023","journal-title":"PharmacoEconomics"},{"key":"key2026090807023400_ref18-bib18","volume-title":"NICE Health Technology Evaluations: The Manual"},{"key":"key2026090807023400_ref19-bib19","doi-asserted-by":"crossref","first-page":"e14017","DOI":"10.1111\/hex.14017","article-title":"Understanding the quality-of-life experiences of older or frail adults following a new dens fracture: Nonsurgical management in a hard collar versus early removal of collar","volume":"27","author":"Closs","year":"2024","journal-title":"Health Expect"},{"key":"key2026090807023400_ref20-bib20","volume-title":"Analyzing Qualitative Data","author":"Ritchie","year":"1994"},{"key":"key2026090807023400_ref21-bib21","doi-asserted-by":"crossref","first-page":"52","DOI":"10.7748\/nr2011.01.18.2.52.c8284","article-title":"Qualitative data analysis: the framework approach","volume":"18","author":"Smith","year":"2011","journal-title":"Nurse Res"},{"key":"key2026090807023400_ref22-bib22","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1191\/1478088706qp063oa","article-title":"Using thematic analysis in psychology","volume":"3","author":"Braun","year":"2006","journal-title":"Qual Res Psychol"},{"key":"key2026090807023400_ref23-bib23","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1002\/hec.3564","article-title":"Valuing health-related quality of life: an EQ-5D-5L value set for England","volume":"27","author":"Devlin","year":"2018","journal-title":"Health Econ"},{"key":"key2026090807023400_ref24-bib24","doi-asserted-by":"crossref","first-page":"642","DOI":"10.1016\/j.jval.2019.10.017","article-title":"The EQ-5D-5L value set for England: findings of a quality assurance program","volume":"23","author":"Hernandez Alava","year":"2020","journal-title":"Value Health"}],"container-title":["Health Technology Assessment"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/njl-admin.nihr.ac.uk\/document\/download\/2051004","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.journalslibrary.nihr.ac.uk\/sites\/journalslibrary\/files\/journal_data\/GJPB0728\/GJPB0728.xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/njl-admin.nihr.ac.uk\/document\/download\/2051004","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T06:50:05Z","timestamp":1788850205000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.journalslibrary.nihr.ac.uk\/hta\/published-articles\/GJPB0728"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5]]},"references-count":24,"alternative-id":["10.3310\/GJPB0728"],"URL":"https:\/\/doi.org\/10.3310\/gjpb0728","relation":{},"ISSN":["2046-4924"],"issn-type":[{"value":"2046-4924","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5]]},"assertion":[{"value":"This content has been made freely available to all.","name":"free","label":"Free to read"},{"value":"02-2021","name":"contractual_start_date","label":"contractual_start_date","group":{"name":"article_history","label":"Article History"}},{"value":"04-2025","name":"editorial_review_begun","label":"editorial review begun","group":{"name":"article_history","label":"Article History"}},{"value":"09-2025","name":"accepted_for_publication","label":"Accepted for publication","group":{"name":"article_history","label":"Article History"}}]}}