ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation) randomised controlled, feasibility in older people trial: a study protocol.
adult orthopaedics
geriatric medicine
health economics
qualitative research
spine
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
10 07 2019
10 07 2019
Historique:
entrez:
13
7
2019
pubmed:
13
7
2019
medline:
6
8
2020
Statut:
epublish
Résumé
Pelvic fragility fractures (PFF) are common in older people and associated with a significant burden of mortality and morbidity. This is related to the challenges of appropriate pain control and early mobilisation. The current standard for treatment of PFF is non-surgical management. Minimally invasive surgical techniques for sacral fracture stabilisation have been shown to improve outcomes in terms of pain control and mobility, and they are safe. Randomised controlled trials are required before recommendations can be made for surgical management of PFF to become the new standard of care. This feasibility study will explore several uncertainties around conducting such a trial. ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation) is a single-site randomised controlled, parallel-arm, feasibility trial of surgical stabilisation versus non-surgical management of acute sacral fragility fractures in people aged 70 years and over. Patients will be randomised to either surgical or non-surgical group on a 1:1 ratio. Follow-up of participants will occur at 2, 4 and 12 weeks with safety data collected at 52 weeks. Primary objectives are to determine feasibility and design of a future trial, including outcomes on recruitment, adherence to randomisation and safety. This will be supplemented with a qualitative interview study of participants and clinicians. Secondary objectives will inform study design procedures to determine clinical and economic outcomes between groups, including scored questionnaires, analgesia requirements, resource use and quality of life data. Data analysis will be largely descriptive to inform outcomes and future sample size. Ethical approval was granted by the North East Newcastle and North Tyneside 2 Research Ethics Committee (reference 18/NE/0212). ASSERT was approved and sponsored by Nottingham University Hospitals NHS Trust (reference 18HC001) and the Health Research Authority (reference IRAS 232791). Recruitment is ongoing. Results will be presented at relevant conferences and submitted to appropriate journals on study completion. ISRCTN16719542; Pre-results.
Identifiants
pubmed: 31296516
pii: bmjopen-2019-032111
doi: 10.1136/bmjopen-2019-032111
pmc: PMC6624053
doi:
Banques de données
ISRCTN
['ISRCTN16719542']
Types de publication
Journal Article
Pragmatic Clinical Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e032111Subventions
Organisme : Department of Health
ID : PB-PG-0816-20002
Pays : United Kingdom
Informations de copyright
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
Références
Injury. 2015 Aug;46(8):1631-6
pubmed: 26052052
Pain Physician. 2017 Nov;20(7):E1063-E1072
pubmed: 29149151
Swiss Med Wkly. 2013 Sep 19;143:w13859
pubmed: 24089312
Clin Orthop Relat Res. 1981 Mar-Apr;(155):43-7
pubmed: 7226629
Injury. 2005 Nov;36(11):1323-9
pubmed: 15979626
BMC Med Res Methodol. 2006 Jul 19;6:34
pubmed: 16854229
Age Ageing. 2015 Mar;44(2):258-61
pubmed: 25365963
Spine (Phila Pa 1976). 2007 Jul 1;32(15):1635-40
pubmed: 17621211
Drugs Aging. 2017 Jan;34(1):1-11
pubmed: 27913981
Postgrad Med J. 2000 Oct;76(900):646-50
pubmed: 11009580
Stat Med. 1995 Sep 15;14(17):1933-40
pubmed: 8532986
J Am Geriatr Soc. 1991 Feb;39(2):142-8
pubmed: 1991946
CMAJ. 2005 Aug 30;173(5):489-95
pubmed: 16129869
J Neurointerv Surg. 2013 Sep 1;5(5):461-6
pubmed: 22684691
Acta Chir Orthop Traumatol Cech. 2015;82(2):101-12
pubmed: 26317181
J Orthop Surg (Hong Kong). 2010 Aug;18(2):153-7
pubmed: 20808004
Am J Phys Med Rehabil. 2000 Jul-Aug;79(4):404-9
pubmed: 10892628
J Orthop Traumatol. 2012 Jun;13(2):97-103
pubmed: 22391943
J Clin Neurosci. 2015 Oct;22(10):1601-8
pubmed: 26162266
Clin Orthop Relat Res. 2014 Aug;472(8):2338-42
pubmed: 24867452
Acta Orthop. 2005 Aug;76(4):513-6
pubmed: 16195067
Age Ageing. 2014 Sep;43(5):648-53
pubmed: 24419459
Radiology. 1986 Aug;160(2):445-51
pubmed: 3726125
Spine (Phila Pa 1976). 1983 Mar;8(2):141-4
pubmed: 6222486
Arch Osteoporos. 2013;8:137
pubmed: 24113838
J Chronic Dis. 1987;40(5):373-83
pubmed: 3558716
Geriatr Orthop Surg Rehabil. 2016 Mar;7(1):9-17
pubmed: 26929851
Eur Spine J. 2009 Sep;18(9):1266-71
pubmed: 19504130
J Am Geriatr Soc. 2005 Apr;53(4):695-9
pubmed: 15817019
J Bone Joint Surg Br. 2001 Nov;83(8):1141-4
pubmed: 11764428
Health Technol Assess. 2007 Nov;11(48):iii, ix-105
pubmed: 17999843
J Eval Clin Pract. 2004 May;10(2):307-12
pubmed: 15189396
PLoS One. 2015 Sep 29;10(9):e0139078
pubmed: 26418971
Injury. 2012 Aug;43(8):1326-9
pubmed: 22682148
Injury. 2013 Dec;44(12):1733-44
pubmed: 23871193
Eur J Trauma Emerg Surg. 2015 Aug;41(4):349-62
pubmed: 26038048
Age Ageing. 1972 Nov;1(4):233-8
pubmed: 4669880
Injury. 2010 Apr;41(4):411-4
pubmed: 20060970
Osteoporos Int. 2005 Oct;16(10):1304-5
pubmed: 16096714
Am Surg. 2009 Apr;75(4):291-5
pubmed: 19385287
Osteoporos Int. 2000;11(5):443-8
pubmed: 10912847
AJNR Am J Neuroradiol. 2014 Nov-Dec;35(11):2202-6
pubmed: 25012675
Arch Phys Med Rehabil. 1994 Feb;75(2):127-32
pubmed: 8311667
Am J Emerg Med. 1997 Oct;15(6):576-8
pubmed: 9337365
J Clin Epidemiol. 2012 Mar;65(3):301-8
pubmed: 22169081
Arch Orthop Trauma Surg. 2009 Dec;129(12):1685-90
pubmed: 19629504
Health Policy. 1990 Dec;16(3):199-208
pubmed: 10109801
Trials. 2006 Apr 07;7:9
pubmed: 16603070
J Vasc Interv Radiol. 2014 Jun;25(6):911-5
pubmed: 24713417
Joint Bone Spine. 2003 Aug;70(4):287-9
pubmed: 12951312
Injury. 2007 Apr;38(4):497-508
pubmed: 17399713
Eur Geriatr Med. 2019 Feb;10(1):147-150
pubmed: 32720277