Title: The ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation)- Randomised Controlled, Feasibility in Older People Trial. Short Title: The ASSERT Trial.
Funder: Department of Health and Social Care

Abstract: Research Background Pelvic ring fractures are common in older people and occur as a result of a low-energy trauma. These fractures are extremely painful, require admission to hospital and are associated with significant morbidity and increased mortality. Pelvic ring fractures can be classified as anterior pelvic ring pubic rami' fractures, or posterior pelvic ring sacral insufficiency' fractures. Sixty to eighty percent of patients aged 75 years and over, admitted to hospital with a pubic rami fracture will have a concomitant sacral insufficiency fracture. The severity of pain, complications and hospital length of stay is greater for patients with these combined fractures compared to patients with a single fracture of the pelvis alone. Pubic rami fractures are relatively stable and therefore can be managed conservatively; however, the optimal treatment of combined pubic rami and sacral insufficiency fractures remains unclear. One approach may be to stabilise the pelvic ring by treating the sacral fracture with bone cement, using key-hole spinal surgery. This has been shown to reduce pain, increase mobility and is safe in older people, although the wider clinical and cost benefits are unknown. Study Aims We propose to evaluate the clinical effectiveness and cost-effectiveness of key-hole spinal surgery in the management of older people presenting acutely to hospital with a combined pubic rami and sacral insufficiency fracture. However, before we undertake such a study, we aim to conduct a feasibility study. Plan of Investigation Design: 30 month, randomised controlled, feasibility study Setting: Secondary care, with community, 3 month, face to face follow-up (12 month safety follow-up) Target population: Aged 70 years and older presenting acutely with a combined low trauma pubic rami and sacral insufficiency fracture to the Nottingham University Hospitals NHS Trust Inclusion: ambulatory with/without walking aids before the injury; Exclusion: unstable pelvic fracture requiring urgent surgery; pathological fracture; previous surgery which contraindicates sacral surgery; comorbidity that precludes general / spinal anaesthesia Intervention: key hole spinal surgery or non-operative (conservative) routine care Measurement of outcomes and costs: We will assess whether there is a pool of eligible patients; whether patients and doctors are willing to be randomised/randomise and if they will then adhere to the randomisation. We will test two primary functional outcome measures- one objective face to face tests (the Timed Up and Go (TUG) and a self-report measure (the Roland Morris Disability Questionnaire (RMDQ)). In addition, we will collect important secondary outcome measures (measurement of pain, analgesia consumed, return to previous function and quality of life) at 1,4 & 12 weeks. Health service resource cost will be collected using established databases and a discussion of social care costs at the 12 week interview. A 12 month safety telephone questionnaire, complemented by a review of the hospital database will also be undertaken. Data on the completeness and variability of the outcome measures will be evaluated. In addition, we will conduct semi structured qualitative interviews to explore participant and clinician experiences and their recommendations for improving trial acceptability and processes. The study will be support by the Leicester Clinical Trials Unit. Patient and NHS Benefit The benefits will be significant to both patients and the NHS. Surgery will improve pain, allow early mobilisation and therefore reduce potential complications related to prolonged immobilisation. This will allow patients to return home sooner and quickly back to their previous level of function. In addition to the direct cost savings by reducing patient complications and hospital length of stay, reduced bed occupancy will have the further benefit of improving hospital bed flow through extra bed available for older people, thereby improving flow through the emergency department.

Lay abstract: 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 with key hole surgery. Background The pelvis is the sturdy ring of bones located at the base of the spine. Broken (fractured) pelvic bones in older people are commonly caused by a low impact, such as a minor fall. These fractures are usually treated without an operation, but are associated with considerable risk of dying and disability, aswell as prolonged hospital stay, and significant healthcare costs. Key hole surgery in this group of patients may be beneficial, but further research is needed to evaluate this. Design and methods Older patients presenting to hospital as an emergency with a fractured pelvis will be randomly offered (that is by chance) to either key hole surgery or no operation (routine care). We will determine whether there are enough patients to take part; whether patients are willing to be randomised; if the doctors are willing to randomise the patients and keep to their decision. 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 rating, pain medication taken; quality of life; interaction with health services and 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. Patient and public involvement We have worked closely with the Nottingham Osteoporosis support group, who have influenced the design of this application, choice of study outcomes and will be involved throughout the study.

Research activity codes: 6.4 SURGERY
Health categories: INJURIES AND ACCIDENTS