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Sheffield Multiple Rib Fractures Study: (SMuRFS)

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ClinicalTrials.gov Identifier: NCT02608541
Recruitment Status : Recruiting
First Posted : November 18, 2015
Last Update Posted : December 22, 2017
Sponsor:
Collaborator:
University of Sheffield
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Rib Fractures 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
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Sheffield Multiple Rib Fractures Study: Evolution of Classification, Management and Outcomes
Actual Study Start Date : October 12, 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Acute Pain [ Time Frame: up to 2 years ]
    Visual Analogue Score


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • Multiple simple rib fractures
  • Flail chest

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608541


Contacts
Contact: John G Edwards, FRCS(C/Th) +44 (0)1142269279 john.edwards@sth.nhs.uk
Contact: Charlotte Culver +44 (0) 114 22 69047 charlotte.culver@sth.nhs.uk

Locations
United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust Recruiting
Sheffield, South Yorkshire, United Kingdom, S5 7AU
Contact: John G Edwards, FRCS(C/Th)    +44 (0)1142269279    john.edwards@sth.nhs.uk   
Contact: Charlotte Culver    +44 (0) 114 22 69047    charlotte.culver@sth.nhs.uk   
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
University of Sheffield
Investigators
Study Chair: John G Edwards, FRCS(C/Th) Sheffield Teaching Hospitals NHS Foundation Trust

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02608541     History of Changes
Other Study ID Numbers: STH19022
183712 ( Other Identifier: IRAS )
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
Multiple Rib Fractures, Frail Chest

Additional relevant MeSH terms:
Fractures, Bone
Rib Fractures
Wounds and Injuries
Thoracic Injuries