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Completed

NCT Number: NCT02608541

Sheffield Multiple Rib Fractures Study:

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

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Key information

Conditions

Rib Fractures Fractures, Bone Thoracic Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S5 7AU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Multiple simple rib fractures
  • Flail chest

Exclusion criteria

-

Treatment and study plan

rib fracture fixation

Other

Use of MatrixRib, where indicated, according to departmental protocol

Primary outcomes

  1. Acute Pain

    Time frame: up to 2 years

    Visual Analogue Score

Secondary outcomes

  1. Forced Expired Volume in 1 second (FEV1)

    Time frame: up to 2 years

  2. Forced Vital Capacity (FVC)

    Time frame: up to 2 years

  3. Length of critical care unit stay

    Time frame: up to 1 year

  4. Complications during critical care unit stay

    Time frame: up to 1 year

    adverse events as assessed by CTCAE v4.0

  5. Length of hospital stay

    Time frame: up to 1 year

  6. Complications during hospital stay

    Time frame: up to 1 year

    adverse events as assessed by CTCAE v4.0

  7. Quality of Life - SF36 (Short Form 36)

    Time frame: up to 2 years

    SF-36

  8. Quality of Life - EQ5D

    Time frame: up to 2 years

    EuroQol Group EQ5D

  9. 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

  10. Quality of Life - EORTC QLQ-LC13 (Lung Cancer13)

    Time frame: up to 2 years

    EORTC QLQ-LC13

  11. Healthcare cost

    Time frame: up to 2 years

    procedural costs plus hospital cost plus community healthcare costs

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Collaborators

  • University of Sheffield

Registry information

Official study title

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

Acronym: SMuRFS

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 18, 2015
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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