The Operative Rib Fixation (ORiF) study

Not Applicable

• Conditions: Rib fractures; Injury, Occupational Diseases, Poisoning; Fracture of rib

• Registration Number: ISRCTN10777575
• Lead Sponsor: ottingham University Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-30
• Last Update Posted: 12 August 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 467

Inclusion Criteria

Patients who present with multiple (three or more) rib fractures suitable for surgical repair and one or more of the following:
1. Clinical flail chest
2. Respiratory difficulty requiring respiratory support
3. Uncontrollable pain using standard modalities

Exclusion Criteria

1. Aged under 16 years
2. Thoracic injury requiring emergent operative or interventional radiology
3. Cannot be operated on within 72 hours as deemed unfit for surgery

Added 06/10/2021:
4. Unwilling or unable to comply with protocol follow up requirements
5. Any other significant disease or condition which, in the opinion of the local research team, may influence the results of the trial or the patient’s ability to participate in the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 11/12/2023: <br><br>All-cause mortality at 12 months<br><br>_____<br><br>Previous primary outcome measure:<br><br>1. All-cause mortality at 12 months<br>2. Quality of life measured using the EQ-5D-5L questionnaire at baseline, 30 days, 3 months, 6 months and 12 months