Treatment Options for Proximal Humerus Fractures in the Elderly and Their Implication on Personal Independence

University Hospital, Basel, Switzerland1 site in 1 country160 target enrollmentMay 1, 2015

ConditionsHumeral Fractures

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Humeral Fractures
Sponsor: University Hospital, Basel, Switzerland
Enrollment: 160
Locations: 1
Primary Endpoint: personal dependency status
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is set to evaluate a proposed standard for the treatment of proximal humerus fractures

Detailed Description

This study investigates the effect of routine treatment algorithm for proximal humerus fractures. All applied treatments are approved and reflect routine practice. The follow-up investigation as planned for this study is associated with only minimal risk for the concerned patients.

Registry

clinicaltrials.gov

Start Date

May 1, 2015

End Date

December 31, 2019

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

University Hospital, Basel, Switzerland

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age of 65 years or above
•Proximal humerus fracture
•Informed consent by the patient or legal representatives to participate in the study

Exclusion Criteria

•More than one fracture, polytrauma
•Suspicion of a pathological fracture in the context of known or unknown malignancy
•Previous surgery of the proximal humerus on the same side
•High energy trauma
•Open Fracture
•Insufficient German language skills

Outcomes

Primary Outcomes

personal dependency status

Time Frame: 6 months

A simple four point rating is used at the time of injury (for the premorbid state) and at 6 months to demonstrate the impact of the injury (including its treatment) on the ability to return to the former social environment and degree of self-dependency.

Secondary Outcomes

General health using EuroQuality of life (EQ)-5D-5L visual analogue scale (VAS)(6 months)
Shoulder pain and disability index (SPADI)(6 months)
SSV(6 months)
Quality of life (utilities) derived using EQ-5D-5L(6 months)
range of motion(6 months)