Surgeons are about to test whether screwing metal plates into the ribs of patients with multiple fractures saves more lives than supportive care alone. Around 532 patients with three or more broken ribs and serious chest injuries will be randomly assigned to either rib fixation surgery plus standard care, or standard care alone—which includes pain relief, physiotherapy, and breathing support. The trial runs across NHS trauma centres and tracks deaths within 90 days, plus quality of life over a year. Current evidence from small studies and registry data suggests surgery could cut short-term mortality by 5 to 11 percentage points. If the trial confirms a survival benefit, rib fixation could become routine NHS practice for severe chest wall injuries, reducing deaths and long-term disability. It would also settle a long-standing debate over whether the cost and risk of surgery—plates, screws, operating time—are justified against supportive management alone. A cost-utility analysis will tell the NHS whether the procedure is worth funding at scale.
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Design: Two-arm multicentre randomised trial nested within a population registry Setting: NHS trauma centres treating severe chest injury across the United Kingdom Target Population: Patients aged 16+ presenting with multiple (3+) rib fractures suitable for surgical repair and an AIS 3+. Patients with head, thoracic or abdominal injuries requiring priority treatment will be excluded. Health Technologies Being Assessed: Comparison of 2 routine NHS management strategies for patients with rib fractures: a) Rib fixation with plates and screws followed by supportive management; b) Supportive management alone (including neuraxial analgesia, physiotherapy, and ventilatory support). Measurement of costs and outcomes: Co-primary outcomes of mortality at 90 days and EQ5D-5L over 12 months. Secondary clinical and patient reported outcomes include ventilator days, complications, further intervention, LOS at 6 and 12 months. Direct data collection for primary outcomes supplemented with Trauma Audit and Research Network (TARN) registry for secondary outcomes and supplementary data. ONS mortality data. A cost-utility analysis will be embedded into the trial design to assess cost-effectiveness of surgical fixation and supportive management versus supportive management alone for the participants. A detailed patient-level assessment of the resource-use and costs of treatment will be performed from the recommended UK NHS and Personal Social Services perspective(10). Health related quality of life will be estimated using the EuroQol(11) administered at baseline and follow-up periods Sample size: Meta-analyses of two small RCTs, our observational study with matched groups, and TARN registry data suggest a large and potentially practice shifting (5-11% absolute) reduction in short term (30-90 day) mortality is realistic for surgery over only supportive management. To detect a target mortality difference of 7% (10 to 3%) at 90 day with 2-sided 5% significance level and 90% statistical power, 532 participants (35 events) will be required (log-rank test). 10% was the observed 90 day mortality in the TARN registry data (2014-16) for AIS 3+ patients receiving supportive management. Mortality is routinely collected within TARN and via ONS, therefore missing data will be negligible. 532 participants is also sufficient for the co-primary outcome, EQ5D-5L, based upon a target mean difference of 0.09 (an important difference for EQ5D-3L), SD of 0.3, at 90% power and 2-sided 5% significance level, allowing for 12% missing data (death is zero). Project Timetable: 54 months in total. 6 months initial set-up (HRA, feasibility, training and set up), 30 months recruiting, 12 months follow-up of the last participant, with 6 months of analysis and write up. We have successfully conducted and reported other NIHR HTA funded RCTs in a similar patient population (WOLLF and FixDT trials). Anticipated recruitment rate is 1-2 patients/month/site. Stop-go assessment at month 6 after recruitment starts. Expertise: Multidisciplinary indluding patients, Orthopaedic & Trauma and Thoracic & Vascular surgeons, intensitivists, senior trialists, methodologists, statisticians, health economists, trial managers and has the full support of a registered CTU (OCTRU), RCS Surgical Trials Unit (SITU) and NHS-E through the National Clinical Director for Trauma. Senior triallists involved have experience of running multicentre surgical trials funded by the HTA (TOPKAT, ACL SNNAP, FiX DT, Wollf).
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