Title: Evaluation of chest wall stabilisation through Operative RIb Fixation (ORIF Study)
Funder: Department of Health and Social Care

Abstract: 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).

Lay abstract: Rib fractures are a common injury. They usually occur as a result of a serious injury, such as that suffered in a road traffic accident or fall from a height. They can also occur in less traumatic accidents, often in the elderly who have fragile bones. Rib fractures are painful, and can cause problems with breathing and coughing. The lung tissue is just underneath the ribs and when a fracture occurs this is also often injured. As a result, rib fractures can lead to problems such as pneumonia, pulmonary effusions (fluid in the lung due to swelling) and some patients can even die as a result of the injury. Most rib fractures are treated without the need for an operation. Doctors use supportive treatments such as pain relief and physiotherapy to help patients recover. Fractures in other bones are usually fixed with an operation that secures the broken bones using metal plates and screws. Recently surgeons have found that some rib fractures can also be fixed in this way. They have also found patients are recovering better and their quality of life improves. However, surgery always carries some risk, especially in patients who have had a major injury. We don’t know if the surgical treatment, and its risks are better than the current non-operative/supportive treatments. We would like to do a research study, called a randomised trial, to look at rib fixation with plates and screws and compare this to the supportive treatments available in the NHS currently. Patients who have a rib fracture and surgeons are unsure if the patient will benefit from surgery or not will be ‘randomly’ allocated to receive either supportive treatment, as is the standard care at their hospital, or to also undergo an operation to stabilise the broken ribs in this way. This will allow us to make a fair comparison. We are interested in patient outcomes (survival after the injury, and quality of life, amongst others), and also the cost of treatment in the NHS. We will look at information about their care after they enter the study until it completes. Most of the information we need to assess the two treatments is commonly collected at hospitals. This is through an existing data collection system run by the Trauma Audit and Research Network (TARN) however some other details will be collected directly from patients by specialist research nurses at routine visits to clinic. We will work with the registry to ensure all relevant data about your care is collected. The study will recruit over 500 patients from major trauma centres across the UK. We will follow the patients up with questionnaires for 12 months.

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