Sheffield Multiple Rib Fractures Study:

NCT ID: NCT02608541

Last Updated: 2019-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-12

Study Completion Date

2018-10-16

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.

Conditions

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Rib Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Retrospective rib fracture fixation

patients presenting since 2006 with multiple rib fractures or flail chest, managed operatively or non-operatively

rib fracture fixation

Intervention Type OTHER

Use of MatrixRib, where indicated, according to departmental protocol

Prospective rib fracture fixation

patients presenting from October 2015 to October 2017 with multiple rib fractures or flail chest, managed operatively or non-operatively

rib fracture fixation

Intervention Type OTHER

Use of MatrixRib, where indicated, according to departmental protocol

Interventions

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rib fracture fixation

Use of MatrixRib, where indicated, according to departmental protocol

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Multiple simple rib fractures
* Flail chest

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sheffield

OTHER

Sponsor Role collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John G Edwards, FRCS(C/Th)

Role: STUDY_CHAIR

Sheffield Teaching Hospitals NHS Foundation Trust

Locations

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Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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183712

Identifier Type: OTHER

Identifier Source: secondary_id

STH19022

Identifier Type: -

Identifier Source: org_study_id

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