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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

 

Chief Investigator

Associate Professor Benjamin Ollivere

Funder

NIHR Health Technology Assessment (HTA) Programme

Sponsor

Nottingham University Hospitals NHS Trust

Sample size

532

Patient population

Aged 16 years+ who have sustained multiple rib fractures

No. of sites

~15 trauma centres in the UK

Start/end dates

01-Jun-2018 until 30-Nov-2022

Primary objectives, to:

  • 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

 

Secondary objectives, to:

  • 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.