Sheffield Multiple Rib Fractures Study: (SMuRFS)

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

Study Overview

• Status: Completed
• Conditions: Rib Fractures
• Intervention / Treatment: Other: rib fracture fixation

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 Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S5 7AU
      • Sheffield Teaching Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

• Multiple simple rib fractures
• Flail chest

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retrospective rib fracture fixation; patients presenting since 2006 with multiple rib fractures or flail chest, managed operatively or non-operatively	Other: rib fracture fixation; 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	Other: rib fracture fixation; Use of MatrixRib, where indicated, according to departmental protocol

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Collaborators: University of Sheffield
• Investigators: Study Chair: John G Edwards, FRCS(C/Th), Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2015
• Primary Completion (Actual): October 16, 2018
• Study Completion (Actual): October 16, 2018

Study Registration Dates

• First Submitted: October 12, 2015
• First Submitted That Met QC Criteria: November 16, 2015
• First Posted (Estimate): November 18, 2015

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Multiple Rib Fractures, Frail Chest
• Additional Relevant MeSH Terms: Wounds and Injuries; Thoracic Injuries; Fractures, Bone; Rib Fractures
• Other Study ID Numbers: STH19022; 183712 (Other Identifier: IRAS)