Fragility fracture of the pelvis Injury, Occupational Diseases, Poisoning
Conditions
Interventions
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 no
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 proce
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 e
Sponsors
Nottingham University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Complex pelvic fractures (e.g. fractures involving/or close to the hip joint) requiring urgent surgery or progressive weight bearing exercises 2. Pathological fracture in the context of known or unknown malignancy 3. Previous surgery of the pelvis with metal obstructing the planned paths of the iliosacral screws 4. Condition that precludes surgery or general/spinal anaesthesia 5. Bedbound prior injury 6. Receiving palliative care 7. Moribund on admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Outcome results
None listed