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

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.

Citation

Ong, T., Suazo Di Paola, A., Brookes, C., Drummond, A., Hendrick, P., Leighton, P., …Sahota, O. (2022). ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation): randomised controlled, feasibility trial in older people. BMJ Open, 12(5), Article e050535. https://doi.org/10.1136/bmjopen-2021-050535

• 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