Trial Status - Open to Recruitment
The Operative Rib Fixation (ORiF) Study: A multicentre randomised controlled trial assessing the mortality, quality of life, and cost effectiveness of operative rib fixation plus supportive care versus supportive care alone for patients with multiple rib fractures requiring ventilator support.
Broken ribs are a common injury which can be painful and cause problems with breathing. When ribs are broken the lungs (which sit underneath) can also be injured and complications like pneumonia can occur. Other broken bones in the body are usually fixed with surgery that secures the broken bones using metal plates and screws. Recently surgeons have found that broken ribs can be fixed in this way. However, surgery always carries some risk, especially in patients with such major injuries. We don't know if the surgery and its risks are better than the current non-operative/supportive treatments. We are doing this research study to try to find out which is better.
- Assess differences in all-cause mortality between the intervention and control groups at 12 months;
- Quantify and draw inferences from observed differences in quality of life over 12 months following surgery.
- Compare patient reported function over 12 months (measured in terms of struggling with breathing, difficulties with independence, anxiety about cosmesis, return to work and return to physical activity);
- Compare the need for further intervention in addition to supportive management versus supportive management alone;
- Compare length of stay (LOS) between the rib fixation with plates and screws in addition to supportive management versus supportive management alone;
- Assess the cost-effectiveness of rib fixation with plates and screws in addition to supportive management versus supportive management alone;
- Assess the generalisability of the findings from the randomised trial against the population registry data using a recent statistical approach.
Outcome measures include: all-cause mortality data; patient reported questionnaires; patient hospital records; registry embedded data collection from the Trauma Audit & Research Network (TARN); cost effectiveness of operative fixation versus standard care.