Treatment of Proximal Humerus Fractures in the Elderly

University Hospital, Basel, Switzerland160 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

160

Conditions

Humeral Fractures

Interventions

treatment/medical devicePROCEDURE

The new treatment algorithm was applied to all patients with proximal humerus fracture as from May 2013 onwards

standardPROCEDURE

The old treatment algorithm was applied to all patients with proximal humerus fracture up to May 2013.

Eligibility

Sex: ALLMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Outcomes

Primary Outcomes

personal dependency status

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.

Time frame: 6 months

Secondary Outcomes

range of motion

Time frame: 6 months

Shoulder pain and disability index (SPADI)

The SPADI is a patient-based questionnaire containing 15 questions about pain and activities of daily living that must be answered by the patient on a scale of 0-10 (0 = no pain / no difficulties to 10 = Worst pain / activity). Five questions relate to the pain and 8 questions relate to the function in daily activities, both subscores are combined and converted to the total score to 0 (= lowest score) to 100 (= best result). A validated German version is available

Time frame: 6 months

SSV

The Subjective Shoulder Value (SSV) is based on a single question that is answered subjectively by the patients. The English formulation of this question is: "What is the overall percent value of your shoulder if a completely normal shoulder represents 100%?" 12 It is an easily administered measure of shoulder function.

Time frame: 6 months

General health using EuroQuality of life (EQ)-5D-5L visual analogue scale (VAS)

The gain in quality of life within two years after surgery is assessed using the generic Quality of Life (QoL) EuroQoL EQ-5D-5L instrument.

Time frame: 6 months

Quality of life (utilities) derived using EQ-5D-5L

Using the EQ-5D-5L instrument patients are asked to report on their general health status on a VAS scale from 0 (worst possible health) to 100 (best possible health).

Data from ClinicalTrials.gov

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