The ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation) study
Research type
Research Study
Full title
The ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation) Randomised Controlled, Feasibility in Older People Trial
IRAS ID
232791
Contact name
Opinder Sahota
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Duration of Study in the UK
2 years, 5 months, 30 days
Research summary
Aim
To undertake a preliminary study to help design a future trial to evaluate the benefits and cost savings of treating older people with broken bones in the pelvis using keyhole spinal surgery.Background
The pelvis is the sturdy ring of bones located at the base of the spine. Breaking the pelvis is common in older people, often caused by a fall from a standing height or less. These fractures are usually treated without an operation, but are associated with considerable risk of dying, significant disability, and enormous healthcare costs.
Keyhole spinal surgery, which involves fixing the pelvis (with bone cement and screws if required), has been shown to be safe and clinical effective. Whether this should now become the standard treatment for this type of injury requires further
research. However before we conduct a large scale study, we will assess whether such a study is feasible.Design and methods
Older patients presenting to hospital with a broken pelvis (broken at the front and the back of the pelvis) will be randomly offered (that is by chance) to either keyhole surgery or no operation (current treatment for these type of fractures).
We will determine whether there are enough patients to take part; whether patients are willing to be randomised; if the doctors are willing to keep to the randomised decisions.
We will collect important measurements (over 12 weeks) to establish whether a future study is practical. The main outcome of a future study will be a measure of mobility, of which we will test two different scales, together with measuring: pain scores, pain medication taken; quality of life; interaction with health services and healthcare costs. In addition we will collect safety follow-up outcome measures at 12 months.The study will be supplemented by interviews with participants and clinicians to explore their experiences and recommendations for improving a future trial.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
18/NE/0212
Date of REC Opinion
5 Jul 2018
REC opinion
Further Information Favourable Opinion