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Sheffield Multiple Rib Fractures Study: (SMuRFS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02608541
Recruitment Status : Completed
First Posted : November 18, 2015
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
University of Sheffield
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Tracking Information
First Submitted Date October 12, 2015
First Posted Date November 18, 2015
Last Update Posted Date February 26, 2019
Actual Study Start Date October 12, 2015
Actual Primary Completion Date October 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 16, 2015)
Acute Pain [ Time Frame: up to 2 years ]
Visual Analogue Score
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 18, 2015)
  • 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
Original Secondary Outcome Measures
 (submitted: November 16, 2015)
  • 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 ]
    in days
  • 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 ]
    in days
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sheffield Multiple Rib Fractures Study:
Official Title Sheffield Multiple Rib Fractures Study: Evolution of Classification, Management and Outcomes
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
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
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Rib Fractures
Intervention Other: rib fracture fixation
Use of MatrixRib, where indicated, according to departmental protocol
Study Groups/Cohorts
  • Retrospective rib fracture fixation
    patients presenting since 2006 with multiple rib fractures or flail chest, managed operatively or non-operatively
    Intervention: Other: rib fracture fixation
  • Prospective rib fracture fixation
    patients presenting from October 2015 to October 2017 with multiple rib fractures or flail chest, managed operatively or non-operatively
    Intervention: Other: rib fracture fixation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 25, 2019)
21
Original Estimated Enrollment
 (submitted: November 16, 2015)
300
Actual Study Completion Date October 16, 2018
Actual Primary Completion Date October 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Multiple simple rib fractures
  • Flail chest

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02608541
Other Study ID Numbers STH19022
183712 ( Other Identifier: IRAS )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sheffield Teaching Hospitals NHS Foundation Trust
Study 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
PRS Account Sheffield Teaching Hospitals NHS Foundation Trust
Verification Date December 2017