ORIF Background

Study 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.

Short Title: The Operative Rib Fixation (ORiF) Study

Study Design: Randomised controlled trial with registry embedded data collection

Sample Size: 524

Study Period: 84 months

Objectives

Outcome measures

Primary

To assess differences in all-cause mortality between the intervention and control groups at 12 months.

All-cause mortality data

Secondary

To quantify and draw inferences from observed differences in quality of life over 12 months following surgery.

EQ-5D-5L index with direct trial collection of primary outcome data

To compare patient reported pain and 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);

Pain Visual Analogue Scale (VAS) and function-related questionnaire

To compare the need for further intervention in addition to supportive management versus supportive management alone;

From patient hospital records/TARN data:

Operative and standard care details

Complications

Further intervention

Ventilator days

To compare length of stay (LOS) between the rib fixation with plates and screws in addition to supportive management versus supportive management alone;

From patient hospital records/TARN data

To assess the cost-effectiveness of rib fixation with plates and screws in addition to supportive management versus supportive management alone;

Health Resource Use questionnaire

To assess the generalisability of the findings from the randomised trial against the population registry data using a recent statistical approach.

TARN data for both randomised and non-randomised patients

(based on Protocol V6.0, 10Jul2023)