ASSERT (Acute Sacral InSufficiEncy FractuRe AugmenTation): Randomised Controlled, Feasibility Trial in Older People

Overview

Journal BMJ Open

Specialty General Medicine

Date 2022 May 3

PMID 35504639

Authors

Terence Ong

Ana Suazo Di Paola

Cassandra Brookes

Avril Drummond

Paul Hendrick

Paul Leighton

Matthew Jones

Khalid Salem

Nasir Quraishi

Opinder Sahota

Affiliations

Soon will be listed here.

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.

Citing Articles

Lateral Compression Fragility Fractures of the Pelvis: Diagnosis, Classifications, and Modern Management.

Patterson J, Parry J Curr Osteoporos Rep. 2024; 22(6):621-631.

PMID: 39313717 PMC: 11499407. DOI: 10.1007/s11914-024-00891-1.

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