ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation): randomised controlled, feasibility trial in older people.
geriatric medicine
orthopaedic & trauma surgery
pain management
trauma management
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
03 05 2022
03 05 2022
Historique:
entrez:
3
5
2022
pubmed:
4
5
2022
medline:
6
5
2022
Statut:
epublish
Résumé
To determine the feasibility of designing and conducting a definitive trial to evaluate the effectiveness of sacral fracture fixation compared with non-surgical management among older people admitted with a lateral compression pelvic fragility fracture (PFF). Single-site, parallel, two-arm randomised controlled feasibility trial. A UK tertiary centre hospital. Patients aged ≥70 years who were ambulating pre-injury requiring hospital admission (within 28 days of injury) with a type 1 lateral compression PFF. The intervention group received sacral fracture fixation (cement augmentation±screw fixation) within 7 days of randomisation. Routine preoperative and postoperative care followed each surgical intervention. The control group received usual care consisting of analgesia, and regular input from the medical and therapy team. The feasibility outcomes were the number of eligible patients, willingness to be randomised, adherence to allocated treatment, retention, data on the completeness and variability of the proposed definitive trial outcome measures, and reported adverse events. 241 patients were screened. 13 (5.4%) were deemed eligible to participate. Among the eligible participants, nine (69.2%) were willing to participate. Five participants were randomised to the intervention group and four to the control group. The clinicians involved were willing to allow their patients to be randomised and adhere to the allocated treatment. One participant in the intervention group and two participants in the control group received their allocated treatment. All participants were followed up until 12 weeks post-randomisation, and had an additional safety follow-up assessment at 12 months. Overall, the proportion of completeness of outcome measures was at least 75%. No adverse events were directly related to the trial. There were significant challenges in recruiting sufficient participants which will need to be addressed prior to a definitive trial. ISRCTN16719542.
Identifiants
pubmed: 35504639
pii: bmjopen-2021-050535
doi: 10.1136/bmjopen-2021-050535
pmc: PMC9066477
doi:
Banques de données
ISRCTN
['ISRCTN16719542']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e050535Informations de copyright
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
Références
Br J Anaesth. 2008 Jul;101(1):17-24
pubmed: 18487245
Injury. 2015 Aug;46(8):1631-6
pubmed: 26052052
Joint Bone Spine. 2012 Oct;79(5):500-3
pubmed: 22284609
CMAJ. 2005 Aug 30;173(5):489-95
pubmed: 16129869
J Orthop Traumatol. 2012 Jun;13(2):97-103
pubmed: 22391943
J Chronic Dis. 1987;40(5):373-83
pubmed: 3558716
Medicine (Baltimore). 2017 Dec;96(51):e9100
pubmed: 29390438
Geriatr Orthop Surg Rehabil. 2016 Mar;7(1):9-17
pubmed: 26929851
J Trauma. 1995 Mar;38(3):453-8
pubmed: 7897737
Spine (Phila Pa 1976). 2000 Dec 15;25(24):3115-24
pubmed: 11124727
Health Policy. 1990 Dec;16(3):199-208
pubmed: 10109801
Phys Ther. 2000 Sep;80(9):896-903
pubmed: 10960937
J Bone Joint Surg Br. 1994 Nov;76(6):882-6
pubmed: 7983111
BMJ Open. 2019 Jul 10;9(7):e032111
pubmed: 31296516
Postgrad Med J. 2000 Oct;76(900):646-50
pubmed: 11009580
J Orthop Trauma. 2019 Feb;33 Suppl 2:S55-S60
pubmed: 30688861
J Neurointerv Surg. 2014 Jan;6(1):57-60
pubmed: 23345629
Swiss Med Wkly. 2013 Sep 19;143:w13859
pubmed: 24089312
J Orthop Trauma. 2014 Dec;28(12):700-6; discussion 706
pubmed: 24662989
J Clin Neurosci. 2015 Oct;22(10):1601-8
pubmed: 26162266
AJNR Am J Neuroradiol. 2010 Feb;31(2):201-10
pubmed: 19762463
Age Ageing. 2014 Sep;43(5):648-53
pubmed: 24419459
Radiology. 1986 Aug;160(2):445-51
pubmed: 3726125
J Clin Med. 2020 Aug 03;9(8):
pubmed: 32756494
Med Arh. 2011;65(5):278-82
pubmed: 22073851
Eur J Trauma Emerg Surg. 2012 Oct;38(5):499-509
pubmed: 23162670
OTJR (Thorofare N J). 2015 Jul;35(3):169-77
pubmed: 26594739
Injury. 2005 Nov;36(11):1323-9
pubmed: 15979626
Osteoporos Int. 2012 Dec;23(12):2797-803
pubmed: 22310957
Am J Surg. 2006 Aug;192(2):211-23
pubmed: 16860634
J Am Geriatr Soc. 2005 Apr;53(4):695-9
pubmed: 15817019
J Neurointerv Surg. 2012 Sep;4(5):385-9
pubmed: 22003050
Osteoporos Int. 2021 Apr;32(4):785-786
pubmed: 33491138
BMJ. 2021 Sep 30;374:n2061
pubmed: 34593508
Arch Phys Med Rehabil. 1994 Feb;75(2):127-32
pubmed: 8311667
Stroke. 2011 Apr;42(4):1146-51
pubmed: 21372310
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