Rib FracturesSMuRFSNCT02608541
Sheffield Multiple Rib Fractures Study:
An observational study of Rib Fractures, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
An observational study to derive clinically relevant and predictive rib fracture classification systems, based on retrospective and prospective cohorts, incorporating assessment of PROMs (Patient Reported Outcome Measures) and healthcare utilisation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fractures
- What is being tested?
- rib fracture fixation
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Oct 2015to 16 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with multiple rib fractures (+/- flail chest) presenting to Sheffield Major Trauma Centre or the surrounding Trauma Units
Who may be able to join
- Multiple simple rib fractures
- Flail chest
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S5 7AU
About this study
Official title: Sheffield Multiple Rib Fractures Study: Evolution of Classification, Management and Outcomes
An observational study to derive clinically relevant and predictive rib fracture classification systems, based on retrospective and prospective cohorts, incorporating assessment of PROMs (Patient Reported Outcome Measures) and healthcare utilisation
Read the detailed description
The aim of this study is to derive radiology-based classifications of rib fractures and to test whether such classifications have a value in the prediction of clinical outcomes and patient reported outcome measures. The first aspect of work is to analyse existing radiology investigations (plain chest radiography (CXR) and derive classifications of rib fractures that, in the retrospective cohort of operated and non-operated cases, could have potential value in the guidance of management and prediction of clinical outcomes. The second aspect will be to evaluate the feasibility of collection of Patient Reported Outcome Measures in patients suffering multiple rib fractures, which will be used to assess the impact of the radiological classifications. The indications for surgery will remain according to current clinical practice and the management algorithms that have been developed previously in the department.
- Conditions
- Rib Fractures
- Being tested
- rib fracture fixation
- Keywords
- Multiple Rib Fractures, Frail Chest
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rib fracture fixationOther
Use of MatrixRib, where indicated, according to departmental protocol
| Study group | Role | What they receive |
|---|---|---|
| Retrospective rib fracture fixation | patients presenting since 2006 with multiple rib fractures or flail chest, managed operatively or non-operatively Receives: Other: rib fracture fixation | |
| Prospective rib fracture fixation | patients presenting from October 2015 to October 2017 with multiple rib fractures or flail chest, managed operatively or non-operatively Receives: Other: rib fracture fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Pain
Visual Analogue Score
Measured: up to 2 years
Secondary outcomes (11)
Forced Expired Volume in 1 second (FEV1)
Measured: up to 2 years
Forced Vital Capacity (FVC)
Measured: up to 2 years
Length of critical care unit stay
Measured: up to 1 year
Complications during critical care unit stay
adverse events as assessed by CTCAE v4.0
Measured: up to 1 year
Length of hospital stay
Measured: up to 1 year
Complications during hospital stay
adverse events as assessed by CTCAE v4.0
Measured: up to 1 year
Quality of Life - SF36 (Short Form 36)
SF-36
Measured: up to 2 years
Quality of Life - EQ5D
EuroQol Group EQ5D
Measured: up to 2 years
Quality of Life - EORTC (European Organisation for the Research and Treatment of Cancer) QLQ-C30 (Quality of Life Questionnaire - Cancer-30)
EORTC QLQ-C30
Measured: up to 2 years
Quality of Life - EORTC QLQ-LC13 (Lung Cancer13)
EORTC QLQ-LC13
Measured: up to 2 years
Healthcare cost
procedural costs plus hospital cost plus community healthcare costs
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study start12 Oct 2015
- Primary completion16 Oct 2018
- Study completion16 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rib FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield
- Responsible party
- Sponsor
- Investigators
- John G Edwards, FRCS(C/Th), Study chair, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608541
- Sponsor's protocol ID
- STH19022
- Other IDs
- 183712
- Acronym
- SMuRFS
- Status last verified
- Dec 2017
- First submitted
- 12 Oct 2015
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sheffield Multiple Rib Fractures Study: Evolution of Classification, Management and Outcomes
- ClinicalTrials.gov ID
- NCT02608541
- Acronym / sponsor ID
- SMuRFS / STH19022
- Conditions
- Rib Fractures
- Keywords
- Multiple Rib Fractures, Frail Chest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield
- Study start
- 12 Oct 2015 (actual)
- Primary completion
- 16 Oct 2018 (actual)
- Study completion
- 16 Oct 2018 (actual)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An observational study to derive clinically relevant and predictive rib fracture classification systems, based on retrospective and prospective cohorts, incorporating assessment of PROMs (Patient Reported Outcome Measures) and healthcare utilisation
Detailed description
The aim of this study is to derive radiology-based classifications of rib fractures and to test whether such classifications have a value in the prediction of clinical outcomes and patient reported outcome measures. The first aspect of work is to analyse existing radiology investigations (plain chest radiography (CXR) and derive classifications of rib fractures that, in the retrospective cohort of operated and non-operated cases, could have potential value in the guidance of management and prediction of clinical outcomes. The second aspect will be to evaluate the feasibility of collection of Patient Reported Outcome Measures in patients suffering multiple rib fractures, which will be used to assess the impact of the radiological classifications. The indications for surgery will remain according to current clinical practice and the management algorithms that have been developed previously in the department.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective rib fracture fixation | – | Other: rib fracture fixationpatients presenting since 2006 with multiple rib fractures or flail chest, managed operatively or non-operatively |
| Prospective rib fracture fixation | – | Other: rib fracture fixationpatients presenting from October 2015 to October 2017 with multiple rib fractures or flail chest, managed operatively or non-operatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with multiple rib fractures (+/- flail chest) presenting to Sheffield Major Trauma Centre or the surrounding Trauma Units
Key inclusion criteria (2 listed)
- Multiple simple rib fractures
- Flail chest
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rib fracture fixationUse of MatrixRib, where indicated, according to departmental protocol | Other | Prospective rib fracture fixation, Retrospective rib fracture fixation |
Primary outcome
Acute Pain
Time frame: up to 2 years
Visual Analogue Score
11 secondary outcomes
Forced Expired Volume in 1 second (FEV1)
Time frame: up to 2 years
Forced Vital Capacity (FVC)
Time frame: up to 2 years
Length of critical care unit stay
Time frame: up to 1 year
Complications during critical care unit stay
Time frame: up to 1 year
Length of hospital stay
Time frame: up to 1 year
Complications during hospital stay
Time frame: up to 1 year
Quality of Life - SF36 (Short Form 36)
Time frame: up to 2 years
Quality of Life - EQ5D
Time frame: up to 2 years
Quality of Life - EORTC (European Organisation for the Research and Treatment of Cancer) QLQ-C30 (Quality of Life Questionnaire - Cancer-30)
Time frame: up to 2 years
Quality of Life - EORTC QLQ-LC13 (Lung Cancer13)
Time frame: up to 2 years
Healthcare cost
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John G Edwards, FRCS(C/Th) study chair
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rib Fractures, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Pain (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.