Rib fractures Injury, Occupational Diseases, Poisoning Fracture of rib
Conditions
Interventions
1:1 randomisation where patients will receive either:
1. Operative rib fixation plus supportive management (intervention)
2. Supportive management alone (control)
Minimisation factors: age
polytrauma
mechanical ventilation and study site
Sponsors
Nottingham University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who present with multiple (three or more) rib fractures suitable for surgical repair and one or more of the following: 1. Clinical flail chest 2. Respiratory difficulty requiring respiratory support 3. Uncontrollable pain using standard modalities
Exclusion criteria
Exclusion criteria: 1. Aged under 16 years 2. Thoracic injury requiring emergent operative or interventional radiology 3. Cannot be operated on within 72 hours as deemed unfit for surgery Added 06/10/2021: 4. Unwilling or unable to comply with protocol follow up requirements 5. Any other significant disease or condition which, in the opinion of the local research team, may influence the results of the trial or the patient’s ability to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 11/12/2023: All-cause mortality at 12 months _____ Previous primary outcome measure: 1. All-cause mortality at 12 months 2. Quality of life measured using the EQ-5D-5L questionnaire at baseline, 30 days, 3 months, 6 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 17/03/2023: 1. Quality of life measured using the EQ-5D-5L questionnaire at baseline, 30 days, 3 months, 6 months and 12 months 2. Patient-reported pain and function measured using the pain Visual Analogue Scale (VAS) and function-related patient questionnaire at 3 months, 6 months and 12 months 3. Need for further intervention assessed using patient medical records and Trauma Audit and Research Network (TARN) data, specifically: operative and supportive management details (until discharge), complications (over 12 months), further intervention (over 12 months), ventilator days (until discharge), CT imaging (at baseline) and x-ray imaging (at 6 – 8 weeks post-discharge for the operative group only) 4. Length of stay (LOS) until discharge, assessed using patient medical records and Trauma Audit & Research Network (TARN) data 5. Cost-effectiveness measured using a Health Resource Use questionnaire at 6 months and 12 months 6. Generalisability of the findings from the randomised trial against the population registry data over 12 months, using a recent statistical approach, using TARN data for both randomised and non-randomised patients Previous secondary outcome measures: 1. Patient-reported pain and function measured using the pain Visual Analogue Scale (VAS) and function-related patient questionnaire at 3 months, 6 months and 12 months 2. Need for further intervention assessed using patient medical records and Trauma Audit and Research Network (TARN) data, specifically: operative and supportive management details (until discharge), complications (over 12 months), further intervention (over 12 months), ventilator days (until discharge), CT imaging (at baseline) and x-ray imaging (at 6 – 8 weeks post-discharge for the operative group only) 3. Length of stay (LOS) until discharge, assessed using patient medical records and Trauma Audit & Research Network (TARN) data 4. Cost-effectiveness measured using a Health Resource Use ques | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactNicholas Beale
Outcome results
None listed