Sheffield Multiple Rib Fractures Study:

Overview

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

Full Title of Study: “Sheffield Multiple Rib Fractures Study: Evolution of Classification, Management and Outcomes”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: October 16, 2018

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.

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Acute Pain
    • Time Frame: up to 2 years
    • Visual Analogue Score

Secondary Measures

  • Forced Expired Volume in 1 second (FEV1)
    • Time Frame: up to 2 years
  • Forced Vital Capacity (FVC)
    • Time Frame: up to 2 years
  • Length of critical care unit stay
    • Time Frame: up to 1 year
  • Complications during critical care unit stay
    • Time Frame: up to 1 year
    • adverse events as assessed by CTCAE v4.0
  • Length of hospital stay
    • Time Frame: up to 1 year
  • Complications during hospital stay
    • Time Frame: up to 1 year
    • adverse events as assessed by CTCAE v4.0
  • Quality of Life – SF36 (Short Form 36)
    • Time Frame: up to 2 years
    • SF-36
  • Quality of Life – EQ5D
    • Time Frame: 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)
    • Time Frame: up to 2 years
    • EORTC QLQ-C30
  • Quality of Life – EORTC QLQ-LC13 (Lung Cancer13)
    • Time Frame: up to 2 years
    • EORTC QLQ-LC13
  • Healthcare cost
    • Time Frame: up to 2 years
    • procedural costs plus hospital cost plus community healthcare costs

Participating in This Clinical Trial

Inclusion Criteria

  • Multiple simple rib fractures – Flail chest Exclusion Criteria:

-

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sheffield Teaching Hospitals NHS Foundation Trust
  • Collaborator
    • University of Sheffield
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • John G Edwards, FRCS(C/Th), Study Chair, Sheffield Teaching Hospitals NHS Foundation Trust

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.