The Operative Rib Fixation (ORiF) Study
Research type
Research Study
Full title
A multicentre randomised controlled trial assessing the mortality, quality of life, and cost effectiveness of operative rib fixation plus supportive management versus supportive management alone for patients with multiple rib fractures requiring ventilator support.
IRAS ID
248460
Contact name
Benjamin Ollivere
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Duration of Study in the UK
3 years, 6 months, 30 days
Research summary
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.
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. Traditionally rib fracture were 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 found operating early on in the care pathway for these patients leads to better recovery and improved quality of life. 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.
ORiF is a randomised controlled trial which will compare management pathways within the first 72hours of admission. These include operative treatment plus standard care versus standard care alone. The study will look at all cause mortality and assess the clinical and cost effectiveness of the treatments and will assess patients' quality of life over a 12 month period. Information about the treatment and outcomes will be collected via patient hospital records, the Trauma Research Audit Network (TARN) and research-specific patient questionnaires.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
18/SC/0666
Date of REC Opinion
24 Dec 2018
REC opinion
Favourable Opinion