Clinical trial NCT02608541: Sheffield Multiple Rib Fractures Study:
Official title: Sheffield Multiple Rib Fractures Study: Evolution of Classification, Management and Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rib Fractures
Keywords: Multiple Rib Fractures, Frail Chest
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Sheffield
First posted: 2015-11-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with multiple rib fractures (+/- flail chest) presenting to Sheffield Major Trauma Centre or the surrounding Trauma Units

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

* Multiple simple rib fractures
* Flail chest

Exclusion Criteria:

-

Primary outcomes:
measure: Acute Pain
timeFrame: up to 2 years
Secondary outcomes:
measure: Forced Expired Volume in 1 second (FEV1)
timeFrame: up to 2 years
measure: Forced Vital Capacity (FVC)
timeFrame: up to 2 years
measure: Length of critical care unit stay
timeFrame: up to 1 year
measure: Complications during critical care unit stay
timeFrame: up to 1 year
measure: Length of hospital stay
timeFrame: up to 1 year
measure: Complications during hospital stay
timeFrame: up to 1 year
measure: Quality of Life - SF36 (Short Form 36)
timeFrame: up to 2 years
measure: Quality of Life - EQ5D
timeFrame: up to 2 years
measure: Quality of Life - EORTC (European Organisation for the Research and Treatment of Cancer) QLQ-C30 (Quality of Life Questionnaire - Cancer-30)
timeFrame: up to 2 years
measure: Quality of Life - EORTC QLQ-LC13 (Lung Cancer13)
timeFrame: up to 2 years
measure: Healthcare cost
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
state: South Yorkshire
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: John G Edwards, FRCS(C/Th)
role: STUDY_CHAIR
References: