Sheffield Multiple Rib Fractures Study:

Rib Fractures Clinical Trial

— SMuRFS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608541
• Other study ID #: STH19022
• Secondary ID: 183712
• Status: Completed
• Start date: October 12, 2015
• Est. completion date: October 16, 2018

Study information

• Verified date: December 2017
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 16, 2018
• Est. primary completion date: October 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Multiple simple rib fractures

• Flail chest

Exclusion Criteria:

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fractures

Intervention

Other:
• rib fracture fixation
Use of MatrixRib, where indicated, according to departmental protocol

Locations

Country	Name	City	State
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield	South Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust	University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

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