Recruiting

Observational Study

Sponsor:

London Health Sciences Centre

Code:

NCT02212600

Conditions

Humeral Fractures, Proximal

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Observational

Study Details

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.

Conditions

Humeral Fractures, Proximal

Study ID

NCT02212600

Start date

Sep 10, 2018

Status verified date

Feb, 2021

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not 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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Observational

observational cohort of proximal humerus fractures

Primary outcome measure

  • Disabilities of the Arm, Shoulder, and Hand (DASH) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Melanie MacNevin

602-284-8105melanie.macnevin@lhsc.on.ca

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Melanie MacNevin

602-284-8105mealnie.macnevin@lhsc.on.ca

Principal Investigator:

Emil Schemitsch, MD. FRCSC

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5C 1R6

Contacts

Milena Vicente

416-864-6060milena.vicente@unityhealth.to

Principal Investigator:

Jeremy Hall, MD, FRCSC

More Information

Sponsor

London Health Sciences Centre

Last update posted

Feb 21, 2021

Last verified

Feb, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre on 2021-02-21.