Sheffield Multiple Rib Fractures Study:

Completed

• Conditions: Rib Fractures
• Interventions: Other: rib fracture fixation

• Registration Number: NCT02608541
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

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.

Study Timeline

• Study Start: 2015-10-12
• Study First Submitted: 2015-10-12
• Study First Submitted QC: 2015-11-16
• Study First Posted: 2015-11-18
• Status Verified: 2017-12
• Primary Completion: 2018-10-16
• Study Completion: 2018-10-16
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Multiple simple rib fractures
• Flail chest

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective rib fracture fixation	rib fracture fixation	patients presenting since 2006 with multiple rib fractures or flail chest, managed operatively or non-operatively
Prospective rib fracture fixation	rib fracture fixation	patients presenting from October 2015 to October 2017 with multiple rib fractures or flail chest, managed operatively or non-operatively

Primary Outcome Measures

Name	Time	Method
Acute Pain	up to 2 years	Visual Analogue Score

Secondary Outcome Measures

Name	Time	Method
Length of critical care unit stay	up to 1 year
Length of hospital stay	up to 1 year
Quality of Life - SF36 (Short Form 36)	up to 2 years	SF-36
Forced Expired Volume in 1 second (FEV1)	up to 2 years
Forced Vital Capacity (FVC)	up to 2 years
Complications during critical care unit stay	up to 1 year	adverse events as assessed by CTCAE v4.0
Complications during hospital stay	up to 1 year	adverse events as assessed by CTCAE v4.0
Quality of Life - EQ5D	up to 2 years	EuroQol Group EQ5D
Quality of Life - EORTC (European Organisation for the Research and Treatment of Cancer) QLQ-C30 (Quality of Life Questionnaire - Cancer-30)	up to 2 years	EORTC QLQ-C30
Quality of Life - EORTC QLQ-LC13 (Lung Cancer13)	up to 2 years	EORTC QLQ-LC13
Healthcare cost	up to 2 years	procedural costs plus hospital cost plus community healthcare costs

Trial Locations

Locations (1)

Sheffield Teaching Hospitals NHS Foundation Trust; 🇬🇧 Sheffield, South Yorkshire, United Kingdom