Sheffield Multiple Rib Fractures Study:

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sheffield Multiple Rib Fractures Study: Evolution of Classification, Management and Outcomes

Conditions
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Rib Fractures

Intervention / Treatment
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* Other: rib fracture fixation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Multiple simple rib fractures Flail chest Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective rib fracture fixation<br>patients presenting since 2006 with multiple rib fractures or flail chest, managed operatively or non-operatively | Other: rib fracture fixation<br>* Use of MatrixRib, where indicated, according to departmental protocol<br>|
| Prospective rib fracture fixation<br>patients presenting from October 2015 to October 2017 with multiple rib fractures or flail chest, managed operatively or non-operatively | Other: rib fracture fixation<br>* Use of MatrixRib, where indicated, according to departmental protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Pain | Visual Analogue Score | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expired Volume in 1 second (FEV1) |  | up to 2 years | 
| Forced Vital Capacity (FVC) |  | up to 2 years | 
| Length of critical care unit stay |  | up to 1 year | 
| Complications during critical care unit stay | adverse events as assessed by CTCAE v4.0 | up to 1 year | 
| Length of hospital stay |  | up to 1 year | 
| Complications during hospital stay | adverse events as assessed by CTCAE v4.0 | up to 1 year | 
| Quality of Life - SF36 (Short Form 36) | SF-36 | up to 2 years | 
| Quality of Life - EQ5D | EuroQol Group EQ5D | 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 | up to 2 years | 
| Quality of Life - EORTC QLQ-LC13 (Lung Cancer13) | EORTC QLQ-LC13 | up to 2 years | 
| Healthcare cost | procedural costs plus hospital cost plus community healthcare costs | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Rib Fractures, Frail Chest