The Operative Rib Fixation (ORiF) study
| ISRCTN | ISRCTN10777575 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10777575 |
| Secondary identifying numbers | 18OR001, HTA 16/61/10 |
- Submission date
- 29/05/2019
- Registration date
- 30/05/2019
- Last edited
- 27/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English Summary
Background and study aims
Rib fractures are a common injury. They usually occur as a result of a serious injury, such as those suffered in a road traffic accident or falling from a height. They can also occur in less traumatic accidents, often in elderly people who have fragile bones. Rib fractures are painful and can cause problems with breathing. Lung tissue sits just underneath the ribs and when a fracture occurs, the lungs are also often injured. As a result, rib fractures can lead to problems such as pneumonia, pulmonary effusions (the build-up of fluid in the lungs due to swelling), and some patients can even die as a result of the injury. Most rib fractures are 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 also found patients are recovering better with an improvement to their quality of life. However, surgery always carries some risk, especially in patients who have had major injuries. It is not known whether surgical treatment, and its risks, is better than the current non-operative/supportive treatments. The aim of this study is to compare rib fixation with plates and screws to the supportive treatments currently available in the NHS.
Who can participate?
Patients with three or more rib fractures suitable for surgical repair and one or more of the following: clinical flail chest, breathing difficulty requiring support, and uncontrollable pain using standard modalities
What does the study involve?
Participants are randomly allocated to receive either supportive treatments, as is the standard care, or to also undergo an operation to stabilise their rib fractures. Patient outcomes (survival after the injury and quality of life, among other things) and also the cost of treatment to the NHS are measured up until study completion at 12 months. Most of the information is routinely collected in hospitals through an existing system, but some other details are collected directly from patients by specialist research nurses at routine visits to the clinic.
What are the possible benefits and risks of participating?
Both supportive management and operative rib fixation are already routinely carried out in the NHS. However, surgery always carries some risk, especially in patients who have experienced major injuries. Although there is some evidence to suggest a reduced length of hospital stay and improved quality of life in some patients who undergo operative rib fixation, a benefit cannot be guaranteed to those who take part in this study. The results from the study are likely to benefit future patients with multiple rib fractures, as it is not known whether the surgery, and its risks, are better than the current non-operative, supportive treatments.
Where is the study run from?
15 trauma centres across the UK
When is the study starting and how long is it expected to run for?
June 2018 to December 2024
Who is funding the study?
NIHR Health Technology Assessment Programme (UK)
Who is the main contact?
1. Prof Benjamin Ollivere, Benjamin.Ollivere@nottingham.ac.uk
2. Mr Nicholas Beale, orif@ndorms.ox.ac.uk
Contact information
Scientific
School of Medicine
Faculty of Medicine and Health Sciences
Queen's Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
 ORCID ID |
0000-0002-1410-1756 |
|---|---|
| Phone | +44 (0)1158 231115 |
| Benjamin.Ollivere@nottingham.ac.uk |
Public
Surgical Intervention Trials Unit
Botnar Research Centre
University of Oxford
Windmill Road
Oxford
OX3 7LD
United Kingdom
| ORCID ID |
0000-0003-4593-706X |
|---|---|
| Phone | +44 (0)1865 613756 |
| orif@ndorms.ox.ac.uk |
Study information
| Study design | Pragmatic interventional multi-centre two-arm parallel group randomized controlled trial nested within a population registry |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Available on request |
| Scientific 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 |
| Study acronym | ORiF |
| Study hypothesis | Operative rib fixation with supportive management is better than supportive management alone. |
| Ethics approval(s) | Approved 28/01/2019, South Central – Berkshire Research Ethics Committee (Easthampstead Baptist Church, South Hill Road, Bracknell, RG12 7NS; Tel: +44 (0)0207 104 8360, +44 (0)2071048046; Email: nrescommittee.southcentral-berkshire@nhs.net), REC ref: 18/SC/0666 |
| Condition | Rib fractures |
| Intervention | 1:1 randomisation where patients will receive either: 1. Operative rib fixation plus supportive management (intervention) 2. Supportive management alone (control) Minimisation factors: age; polytrauma; mechanical ventilation and study site |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Current primary outcome measure as of 11/12/2023: All-cause mortality at 12 months _____ Previous primary outcome measure: 1. All-cause mortality at 12 months 2. Quality of life measured using the EQ-5D-5L questionnaire at baseline, 30 days, 3 months, 6 months and 12 months |
| Secondary outcome measures | Current secondary outcome measures as of 17/03/2023: 1. Quality of life measured using the EQ-5D-5L questionnaire at baseline, 30 days, 3 months, 6 months and 12 months 2. Patient-reported pain and function measured using the pain Visual Analogue Scale (VAS) and function-related patient questionnaire at 3 months, 6 months and 12 months 3. Need for further intervention assessed using patient medical records and Trauma Audit and Research Network (TARN) data, specifically: operative and supportive management details (until discharge), complications (over 12 months), further intervention (over 12 months), ventilator days (until discharge), CT imaging (at baseline) and x-ray imaging (at 6 – 8 weeks post-discharge for the operative group only) 4. Length of stay (LOS) until discharge, assessed using patient medical records and Trauma Audit & Research Network (TARN) data 5. Cost-effectiveness measured using a Health Resource Use questionnaire at 6 months and 12 months 6. Generalisability of the findings from the randomised trial against the population registry data over 12 months, using a recent statistical approach, using TARN data for both randomised and non-randomised patients Previous secondary outcome measures: 1. Patient-reported pain and function measured using the pain Visual Analogue Scale (VAS) and function-related patient questionnaire at 3 months, 6 months and 12 months 2. Need for further intervention assessed using patient medical records and Trauma Audit and Research Network (TARN) data, specifically: operative and supportive management details (until discharge), complications (over 12 months), further intervention (over 12 months), ventilator days (until discharge), CT imaging (at baseline) and x-ray imaging (at 6 – 8 weeks post-discharge for the operative group only) 3. Length of stay (LOS) until discharge, assessed using patient medical records and Trauma Audit & Research Network (TARN) data 4. Cost-effectiveness measured using a Health Resource Use questionnaire at 6 months and 12 months 5. Generalisability of the findings from the randomised trial against the population registry data over 12 months, using a recent statistical approach, using TARN data for both randomised and non-randomised patients |
| Overall study start date | 01/06/2018 |
| Overall study end date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 524 |
| Total final enrolment | 467 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/04/2019 |
| Recruitment end date | 31/07/2024 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Derby Road
Nottingham
NG7 2UH
United Kingdom
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Morriston
Swansea
SA6 6NL
United Kingdom
Headley Way
Oxford
OX3 9DU
United Kingdom
Whitechapel Road
London
E1 1FR
United Kingdom
Mindelsohn Way
Birmingham
B15 2GW
United Kingdom
Derriford
Plymouth
PL6 8DH
United Kingdom
London
SE5 9RS
United Kingdom
Lower Lane
Liverpool
L9 7AL
United Kingdom
Bristol
BS2 8HW
United Kingdom
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Hull
HU3 2JZ
United Kingdom
Leicester
LE3 9QP
United Kingdom
Praed Street
London
W2 1NY
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Summerfield House
2 Eday Road
Aberdeen
AB15 6RE
United Kingdom
Sponsor information
Hospital/treatment centre
Research & Innovation
Queen’s Medical Centre
Derby Road
Nottingham
NG7 2UH
England
United Kingdom
| Phone | +44 (0)1159 249924 |
|---|---|
| ResearchSponsor@nuh.nhs.uk | |
"ROR" |
https://ror.org/05y3qh794 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/10/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The findings will be published in a high impact peer-reviewed journal and will be disseminated across the surgical and anaesthetic communities, the wider medical community and NICE. Study papers will be published in high impact factor journals and will be made available under open access so that high visibility of the work will be maintained as per the NIHR policy. |
| IPD sharing plan | Current IPD sharing statement as of 17/03/2023: On completion of the study, and with appropriate participant consent, fully anonymised data may be shared with other organisations at the behest of the funder. All requests for the use of the data from the ORiF study will be approved by the CI, TMG and where necessary the TSC. A data request form should be completed detailing the decision as to whether the request is accepted. In cases where individual site data is requested, only summary data would be provided with caveats for dissemination, to emphasise that trial data should be interpreted as a whole. Previous IPD sharing statement: The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 6.0 | 10/07/2023 | 16/12/2024 | No | No |
| Statistical Analysis Plan | version 1.0 | 20/12/2024 | 27/02/2025 | No | No |
Additional files
Editorial Notes
27/02/2025: Statistical analysis plan uploaded.
16/12/2024: Uploaded protocol (not peer-reviewed) as an additional file.
03/12/2024: A contact telephone number was changed.
02/08/2024: The following changes were made to the study record:
1. Total final enrolment added.
2. The recruitment end date was changed from 30/06/2024 to 31/07/2024.
3. Aberdeen Royal Infirmary added as a study participating centre.
11/12/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2023 to 30/06/2024.
2. The primary outcome measure was changed.
3. The country of recruitment 'Scotland' was added.
17/03/2023: The following updates have been made to the study record:
1. The secondary outcome measures have been changed.
2. The target number of participants has been changed from 532 to 524.
3. The Individual participant data (IPD) sharing statement and summary have been changed.
15/11/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/06/2022 to 31/12/2023.
2. The overall end date was changed from 30/11/2022 to 31/12/2024.
3. The intention to publish date was changed from 01/04/2023 to 01/10/2025.
4. The plain English summary was updated to reflect these changes.
5. The trial participating centres St. Mary’s Hospital, Manchester Royal Infirmary, University Hospital of Wales were added.
13/05/2022: The public contact's details have been updated.
12/05/2022: The following changes have been made:
1. Hull Royal Infirmary and Glenfield Hospital have been added to the trial participating centres.
2. The overall trial end date has been changed from 01/10/2022 to 30/11/2022 and the plain English summary updated accordingly.
3. The public contact has been changed.
06/10/2021: The following changes were made to the trial record:
1. The following trial participating centres were added: John Radcliffe Hospital, Royal London Hospital, Queen Elizabeth Hospital, Derriford Hospital, King’s College Hospital, Aintree University Hospital, Bristol Royal Infirmary, Southmead Hospital.
2. The contact details and exclusion criteria updated.
3. The recruitment end date was changed from 01/09/2021 to 01/06/2022.
21/09/2020: Recruitment has resumed.
20/04/2020: Due to current public health guidance, recruitment for this study has been paused.
29/05/2019: Trial's existence confirmed by the NIHR.
