Determinants of Function and Clinically Important Outcomes in Proximal Humerus Fractures

• Conditions: Humeral Fractures, Proximal
• Interventions: Other: Observational

• Registration Number: NCT02212600
• Lead Sponsor: London Health Sciences Centre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-06
• Study First Submitted QC: 2014-08-06
• Study First Posted: 2014-08-08
• Study Start: 2018-09-10
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Population	Observational	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

Primary Outcome Measures

Name	Time	Method
Disabilities of the Arm, Shoulder, and Hand (DASH)	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.

Secondary Outcome Measures

Name	Time	Method
Rate of complications	2 years	Clinical outcomes will include range of motion measurements, standardized radiographic evaluation, assessment of complications, rate of re-operation, infections, osteonecrosis.

Trial Locations

Locations (2)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada