Determinants of Function and Clinically Important Outcomes in Proximal Humerus Fractures

NCT ID: NCT02212600

Last Updated: 2021-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-10

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Humeral Fractures, Proximal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Observational

Intervention Type OTHER

observational cohort of proximal humerus fractures

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Observational

observational cohort of proximal humerus fractures

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

males and females age 50 years or older (no uper age limit) presenting with an acute displaced or undisplaced proximal humerus fracture

Exclusion Criteria

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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Unity Health Toronto

OTHER

Sponsor Role collaborator

London Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Emil Schemitsch

MD, FRCSC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Emil Schemitsch, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

London Health Scieneces Centre and St. Michael's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

London Health Sciences Centre

London, Ontario, Canada

Site Status RECRUITING

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Melanie MacNevin

Role: CONTACT

602-284-8105

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Melanie MacNevin

Role: primary

602-284-8105

Milena Vicente

Role: primary

416-864-6060 ext. 2608

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DECIPHER

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

LPHP-Philos-PHN Conservative Treatment
NCT00205959 COMPLETED PHASE4