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ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation): randomised controlled, feasibility trial in older people

Ong, Terence; Suazo Di Paola, Ana; Brookes, Cassandra; Drummond, Avril; Hendrick, Paul; Leighton, Paul; Jones, Matthew; Salem, Khalid; Quraishi, Nasir; Sahota, Opinder

ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation): randomised controlled, feasibility trial in older people Thumbnail


Authors

Terence Ong

Ana Suazo Di Paola

Cassandra Brookes

AVRIL DRUMMOND avril.drummond@nottingham.ac.uk
Professor of Healthcare Research

Paul Hendrick

PAUL LEIGHTON PAUL.LEIGHTON@NOTTINGHAM.AC.UK
Associate Professor of Applied Health Services Research

Dr MATTHEW JONES MATTHEW.JONES3@NOTTINGHAM.AC.UK
Assistant Professor in Health Economics

Khalid Salem

Nasir Quraishi

Opinder Sahota



Abstract

Objective 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). Design Single-site, parallel, two-arm randomised controlled feasibility trial. Setting A UK tertiary centre hospital. Participants Patients aged ≥70 years who were ambulating pre-injury requiring hospital admission (within 28 days of injury) with a type 1 lateral compression PFF. Interventions 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. Primary and secondary outcome measures 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. Results 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. Conclusions There were significant challenges in recruiting sufficient participants which will need to be addressed prior to a definitive trial. Trial registration number ISRCTN16719542.

Journal Article Type Article
Acceptance Date Apr 21, 2022
Online Publication Date May 3, 2022
Publication Date May 3, 2022
Deposit Date Jul 14, 2022
Publicly Available Date Jul 14, 2022
Journal BMJ Open
Electronic ISSN 2044-6055
Publisher BMJ
Peer Reviewed Peer Reviewed
Volume 12
Issue 5
Article Number e050535
DOI https://doi.org/10.1136/bmjopen-2021-050535
Keywords General Medicine
Public URL https://nottingham-repository.worktribe.com/output/7956725
Publisher URL https://bmjopen.bmj.com/content/12/5/e050535