The ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation) study

INTERVENTION: TRIAL DESIGN Parallel, two‐arm randomised controlled trial with participants individually allocated on a 1:1 ratio to either surgical intervention (keyhole surgical intervention) or non‐surgical conservative care. Embedded within the feasibility study will be a health economic analysis to understand resource utilisation and implication of such an intervention; and a qualitative study which will focus on the experiences of participants and clinicians involved in the study, their insights and further recommendations for improving trial acceptability and processes. TRIAL SETTING The study will be conducted in a single site, Queens Medical Centre, Nottingham University Hospitals NHS Trust (acute trust catchment population 700,000; tertiary spinal surgical unit catchment population 3.5 million). Participants will be recruited from the Queens Medical Centre, Nottingham University Hospitals NHS Trust with follow up conducted in either the acute hospital, rehabilitation facility or participant’s place of residence depending on where there will be at the time of the respective follow up schedule. The study will be delivered in collaboration with the Leicester Clinical Trials Unit (LCTU). The LCTU will be responsible for site set‐up and training, randomisation, database development and maintenance, data management, trial management, statistical analysis and monitoring of data quality and trial conduct. A trial manager appointed by the LCTU will oversee the day‐to‐day running of the trial. Participants will be randomly allocated to either surgical intervention or conservative non‐surgical care on the day they consent via a secure web based system maintained by the LCTU. This will be undertaken using computer generated permuted balanced blocks of randomly varying size. The research assistant (RA) will electronically contact the web based system and each participant will receive a randomisation number. Participants and their GPs will be notified of allocation to either surg CONDITION: Specialty: Ageing, Primary sub‐specialty: Ageing; UKCRC code/ Disease: Injuries and accidents/ Injuries to the abdomen, lower back, lumbar spine and pelvis ; Injury, Occupational Diseases, Poisoning PRIMARY OUTCOME: Feasibility study primary outcomes:; 1. Number of eligible patients; 2. Number of patients and doctors willing to be randomised/randomise and adherence to randomisation; Timepoint(s): 12 weeks INCLUSION CRITERIA: 1. Participants presenting to the Nottingham University Hospital NHS Trust with a Pelvic Fragility Fracture involving fractures at both the front and back of the pelvis 2. Aged 70 years and over 3. Ambulatory with/without walking aids before the injury 4. Injury sustained within 5 days of presenting to hospital SECONDARY OUTCOME: 1. Rate of participant recruitment and retention; 2. Clinician adherence to randomisation; 3. Data on the completeness and variability of outcome measures; 4. Adverse events and failure of non‐operative conservative treatment; ; Outcomes for the subsequent definitive trial to be tested:; ; Primary outcome measures:; 1. Mobility is measured using the Timed Up and Go Test (TUG) at Week 1; 2. Disability is measured using the Roland Morris Disability Questionnaire (RMDQ) at Weeks 1, 4, 12; ; Secondary outcome measures:; 1. Fracture information based on clinical assessment of fracture type (bilateral or unilateral) and suitability for surgery at baseline; 2. Surgery details, including information on staffing, length of procedure, intraoperative complications, x‐ray usage, per‐operative cover, anaesthetic, intervention performed and any adverse events captured in the CRFs and medical notes at Week 0, Day of Surgery; 3. Mental capacity is measured using the MoCA at baseline; 4. Health status and predictions of mortality are assessed using the Charlson CoMorbidity Assessment at baseline; 5. Pain is measured using the Numeric Pain Rating Scale at baseline and Weeks 1, 4, 12; 6. Quality of life is measured using the EQ‐5D‐3L at Week 12; 7. Activity level is measured using the Barthel Activities of Daily Living Index at baseline and Weeks 1, 12; 8. Analgesia use is measured using information from medical notes during surgery and postoperatively at baseline and Weeks 1, 4, 12; 9. Health and social care resource use, measured using health economics questionnaires and qualitative interviews at Week 12