Determinants of Function and Clinically Important Outcomes in Proximal Humerus Fractures

Humeral Fractures, Proximal Clinical Trial

Official title:

The DECIPHER Study: Determinants of Function and Clinically Important Outcomes in Proximal Humerus Fractures in the Elder Population: A National Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02212600
• Other study ID #: DECIPHER
• Status: Recruiting
• Start date: September 10, 2018
• Est. completion date: December 2023

Study information

• Verified date: February 2021
• Source: London Health Sciences Centre
• Contact: Melanie MacNevin
• Phone: 602-284-8105
• Email: melanie.macnevin[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. Approximately 10 centres will participate in this observational cohort, each enrolling at least 50 patients over the course of 2 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Humeral Fractures, Proximal
• Shoulder Fractures

Intervention

Other:
• Observational
observational cohort of proximal humerus fractures

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
London Health Sciences Centre	Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of complications	Clinical outcomes will include range of motion measurements, standardized radiographic evaluation, assessment of complications, rate of re-operation, infections, osteonecrosis.	2 years