NCT02608541

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

October 12, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2018

Completed
Last Updated

February 26, 2019

Status Verified

December 1, 2017

Enrollment Period

3 years

First QC Date

October 12, 2015

Last Update Submit

February 25, 2019

Conditions

Rib Fractures

Keywords

Multiple Rib Fractures, Frail Chest

Outcome Measures

Primary Outcomes (1)

  • Acute Pain

    Visual Analogue Score

    up to 2 years

Secondary Outcomes (11)

  • Forced Expired Volume in 1 second (FEV1)

    up to 2 years

  • Forced Vital Capacity (FVC)

    up to 2 years

  • Length of critical care unit stay

    up to 1 year

  • Complications during critical care unit stay

    up to 1 year

  • Length of hospital stay

    up to 1 year

  • +6 more secondary outcomes

Study Arms (2)

Retrospective rib fracture fixation

patients presenting since 2006 with multiple rib fractures or flail chest, managed operatively or non-operatively

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

Other: rib fracture fixation

Interventions

rib fracture fixationOTHER

Use of MatrixRib, where indicated, according to departmental protocol

Prospective rib fracture fixationRetrospective rib fracture fixation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with multiple rib fractures (+/- flail chest) presenting to Sheffield Major Trauma Centre or the surrounding Trauma Units

You may qualify if:

  • Multiple simple rib fractures
  • Flail chest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Location

MeSH Terms

Conditions

Rib Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesThoracic Injuries

Study Officials

  • John G Edwards, FRCS(C/Th)

    Sheffield Teaching Hospitals NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2015

First Posted

November 18, 2015

Study Start

October 12, 2015

Primary Completion

October 16, 2018

Study Completion

October 16, 2018

Last Updated

February 26, 2019

Record last verified: 2017-12

Locations

GB(1)