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
Introduction Fractures of the odontoid process frequently result from low impact falls in frail or older adults. These are increasing in incidence and importance as the population ages. In the UK, odontoid fractures in older adults are usually managed in hard collars to immobilise the fracture and p...
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BMJ Publishing Group
2022-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/7/e057753.full |
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| author | John Norrie Julie Woodfield David J Lowe Paul M Brennan Catriona Keerie Julia Lawton Matthew J Reed Andrew Stoddart Julia Boyd Helen Eborall Gina Cranswick James Tomlinson Polly L Black Sadaquate Khan Patrick Statham Ellie Edlmann Phillip Correia Copley Angela Niven Susan Deborah Shenkin |
| author_facet | John Norrie Julie Woodfield David J Lowe Paul M Brennan Catriona Keerie Julia Lawton Matthew J Reed Andrew Stoddart Julia Boyd Helen Eborall Gina Cranswick James Tomlinson Polly L Black Sadaquate Khan Patrick Statham Ellie Edlmann Phillip Correia Copley Angela Niven Susan Deborah Shenkin |
| author_sort | John Norrie |
| collection | DOAJ |
| description | Introduction Fractures of the odontoid process frequently result from low impact falls in frail or older adults. These are increasing in incidence and importance as the population ages. In the UK, odontoid fractures in older adults are usually managed in hard collars to immobilise the fracture and promote bony healing. However, bony healing does not always occur in older adults, and bony healing is not associated with quality of life, functional, or pain outcomes. Further, hard collars can cause complications such as skin pressure ulcers, swallowing difficulties and difficulties with personal care. We hypothesise that management with no immobilisation may be superior to management in a hard collar for older or frail adults with odontoid fractures.Methods and analyses This is the protocol for the Duration of External Neck Stabilisation (DENS) trial—a non-blinded randomised controlled trial comparing management in a hard collar with management without a collar for older (≥65 years) or frail (Rockwood Clinical Frailty Scale ≥5) adults with a new odontoid fracture. 887 neurologically intact participants with any odontoid process fracture type will be randomised to continuing with a hard collar (standard care) or removal of the collar (intervention). The primary outcome is quality of life measured using the EQ-5D-5L at 12 weeks. Secondary outcomes include pain scores, neck disability index, health and social care use and costs, and mortality.Ethics and dissemination Informed consent for participation will be sought from those able to provide it. We will also include those who lack capacity to ensure representativeness of frail and acutely unwell older adults. Results will be disseminated via scientific publication, lay summary, and visual abstract. The DENS trial received a favourable ethical opinion from the Scotland A Research Ethics Committee (21/SS/0036) and the Leeds West Research Ethics Committee (21/YH/0141).Trial registration number NCT04895644. |
| format | Article |
| id | doaj-art-e857b81f412a48a388cb833e971c6120 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-e857b81f412a48a388cb833e971c61202025-01-31T03:10:10ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2021-057753Duration of External Neck Stabilisation (DENS) following odontoid fracture in older or frail adults: protocol for a randomised controlled trial of collar versus no collarJohn Norrie0Julie Woodfield1David J Lowe2Paul M Brennan3Catriona Keerie4Julia Lawton5Matthew J Reed6Andrew Stoddart7Julia Boyd8Helen Eborall9Gina Cranswick10James Tomlinson11Polly L Black12Sadaquate Khan13Patrick Statham14Ellie Edlmann15Phillip Correia Copley16Angela Niven17Susan Deborah Shenkin18professor of medical statistics and trial methodologyDepartment of Clinical Neurosciences, NHS Lothian, Edinburgh, UKDepartment of Emergency, Queen Elizabeth University Hospital Campus, Glasgow, UKTranslational Neurosurgery, Centre for Clinical Brain Sciences, The University of Edinburgh, Edinburgh, UKUniversity of Edinburgh College of Medicine and Veterinary Medicine, Edinburgh, UKUniversity of Edinburgh Usher Institute of Population Health Sciences and Informatics, Edinburgh, UKEmergency Medicine Research Group Edinburgh (EMERGE), NHS Lothian, Edinburgh, UKEdinburgh Health Services Research Unit, The University Of Edinburgh, Edinburgh, UK5 Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, 3 Little France Road, Edinburgh, UKThe University of Edinburgh Usher Institute of Population Health Sciences and Informatics, Edinburgh, UKEdinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UKSheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UKEmergency Medicine Research Group (EMERGE), NHS Lothian, Edinburgh, UKDepartment of Clinical Neurosciences, NHS Lothian, Edinburgh, UKInstitute of Medical and Biological Engineering, Faculty of Engineering and Physical Sciences, University of Leeds, Leeds, UKSouthwest Neurosurgical Centre, Derriford Hospital, Plymouth, UKDepartment of Clinical Neurosciences, NHS Lothian, Edinburgh, UKEdinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UKUniversity of Edinburgh Usher Institute of Population Health Sciences and Informatics, Edinburgh, UKIntroduction Fractures of the odontoid process frequently result from low impact falls in frail or older adults. These are increasing in incidence and importance as the population ages. In the UK, odontoid fractures in older adults are usually managed in hard collars to immobilise the fracture and promote bony healing. However, bony healing does not always occur in older adults, and bony healing is not associated with quality of life, functional, or pain outcomes. Further, hard collars can cause complications such as skin pressure ulcers, swallowing difficulties and difficulties with personal care. We hypothesise that management with no immobilisation may be superior to management in a hard collar for older or frail adults with odontoid fractures.Methods and analyses This is the protocol for the Duration of External Neck Stabilisation (DENS) trial—a non-blinded randomised controlled trial comparing management in a hard collar with management without a collar for older (≥65 years) or frail (Rockwood Clinical Frailty Scale ≥5) adults with a new odontoid fracture. 887 neurologically intact participants with any odontoid process fracture type will be randomised to continuing with a hard collar (standard care) or removal of the collar (intervention). The primary outcome is quality of life measured using the EQ-5D-5L at 12 weeks. Secondary outcomes include pain scores, neck disability index, health and social care use and costs, and mortality.Ethics and dissemination Informed consent for participation will be sought from those able to provide it. We will also include those who lack capacity to ensure representativeness of frail and acutely unwell older adults. Results will be disseminated via scientific publication, lay summary, and visual abstract. The DENS trial received a favourable ethical opinion from the Scotland A Research Ethics Committee (21/SS/0036) and the Leeds West Research Ethics Committee (21/YH/0141).Trial registration number NCT04895644.https://bmjopen.bmj.com/content/12/7/e057753.full |
| spellingShingle | John Norrie Julie Woodfield David J Lowe Paul M Brennan Catriona Keerie Julia Lawton Matthew J Reed Andrew Stoddart Julia Boyd Helen Eborall Gina Cranswick James Tomlinson Polly L Black Sadaquate Khan Patrick Statham Ellie Edlmann Phillip Correia Copley Angela Niven Susan Deborah Shenkin 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 BMJ Open |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/12/7/e057753.full |
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