Determinants of Function and Clinically Important Outcomes in Proximal Humerus Fractures
The DECIPHER Study: Determinants of Function and Clinically Important Outcomes in Proximal Humerus Fractures in the Elder Population: A National Cohort
1 other identifier
observational
500
1 country
2
Brief Summary
The proposed project will be a multi-centre, prospective observational study to determine the prognosis and determinants of functional outcomes of patients with proximal humerus fractures. Approximately 10 centres will participate in this observational cohort, each enrolling at least 50 patients over the course of 2 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2018
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2014
CompletedFirst Posted
Study publicly available on registry
August 8, 2014
CompletedStudy Start
First participant enrolled
September 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedFebruary 21, 2021
February 1, 2021
5.2 years
August 6, 2014
February 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Disabilities of the Arm, Shoulder, and Hand (DASH)
The DASH is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with musculoskeletal disorders of the upper limb.
2 years
Secondary Outcomes (1)
Rate of complications
2 years
Study Arms (1)
Population
We will include male and female patients who are over 50 years of age and who have an acute, displaced or undisplaced proximal humerus fracture caused by low energy trauma
Interventions
Eligibility Criteria
We will include male and female patients who are over 50 years of age and who have an acute, displaced or undisplaced proximal humerus fracture caused by low energy trauma and who provide written informed consent.
You may qualify if:
- males and females age 50 years or older (no uper age limit) presenting with an acute displaced or undisplaced proximal humerus fracture
You may not qualify if:
- pathologic fractures patients likely to be lost before completing follow-up patients who do not provide consent patients who do not speak English and who do not have a translator that will be available during consent discussion and at each follow-up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- London Health Sciences Centrelead
- Unity Health Torontocollaborator
Study Sites (2)
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
St. Michael's Hospital
Toronto, Ontario, M5C 1R6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emil Schemitsch, MD, FRCSC
London Health Scieneces Centre and St. Michael's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, FRCSC
Study Record Dates
First Submitted
August 6, 2014
First Posted
August 8, 2014
Study Start
September 10, 2018
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
February 21, 2021
Record last verified: 2021-02