Humeral Fractures, ProximalNCT02212600
Determinants of Function and Clinically Important Outcomes in Proximal Humerus Fractures
An observational study of Humeral Fractures, Proximal, run by London Health Sciences Centre at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Humeral Fractures, Proximal
- What is being tested?
- Observational
- How many people
- 500 participants
- Where
- 2 sitesCanada
- Study dates
- 10 Sep 2018to Dec 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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 and who provide written informed consent.
Who may be able to join
- males and females age 50 years or older (no uper age limit) presenting with an acute displaced or undisplaced proximal humerus fracture
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario, N6A 5A5
Melanie MacNevin, 602-284-8105, mealnie.macnevin@lhsc.on.ca
Emil Schemitsch, MD. FRCSC
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5C 1R6
Milena Vicente, 416-864-6060 ext. 2608, milena.vicente@unityhealth.to
Jeremy Hall, MD, FRCSC
About this study
Official title: The DECIPHER Study: Determinants of Function and Clinically Important Outcomes in Proximal Humerus Fractures in the Elder Population: A National Cohort
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.
- Conditions
- Humeral Fractures, Proximal
- Being tested
- Observational
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
observational cohort of proximal humerus fractures
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
Rate of complications
Clinical outcomes will include range of motion measurements, standardized radiographic evaluation, assessment of complications, rate of re-operation, infections, osteonecrosis.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study start10 Sep 2018
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humeral Fractures, ProximalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto
- Responsible party
- Principal investigator, Emil Schemitsch, London Health Sciences Centre
- Investigators
- Emil Schemitsch, MD, FRCSC, Principal investigator, London Health Scieneces Centre and St. Michael's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212600
- Sponsor's protocol ID
- DECIPHER
- Status last verified
- Feb 2021
- First submitted
- 6 Aug 2014
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DECIPHER Study: Determinants of Function and Clinically Important Outcomes in Proximal Humerus Fractures in the Elder Population: A National Cohort
- ClinicalTrials.gov ID
- NCT02212600
- Acronym / sponsor ID
- DECIPHER
- Conditions
- Humeral Fractures, Proximal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- London Health Sciences CentreUniversity, hospital or other
- Collaborators
- Unity Health Toronto
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 8 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Population | – | Other: ObservationalWe 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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 and who provide written informed consent.
Key inclusion criteria (1 listed)
- males and females age 50 years or older (no uper age limit) presenting with an acute displaced or undisplaced proximal humerus fracture
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observationalobservational cohort of proximal humerus fractures | Other | Population |
Primary outcome
Disabilities of the Arm, Shoulder, and Hand (DASH)
Time frame: 2 years
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.
1 secondary outcome
Rate of complications
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emil Schemitsch, MD, FRCSC principal investigator
London Health Scieneces Centre and St. Michael's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Humeral Fractures, Proximal, run by London Health Sciences Centre at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melanie MacNevin (602-284-8105, melanie.macnevin@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of the Arm, Shoulder, and Hand (DASH) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.