Humeral Fractures
Conditions
Keywords
elderly
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.
Interventions
PROCEDUREtreatment/medical device
The new treatment algorithm was applied to all patients with proximal humerus fracture as from May 2013 onwards
PROCEDUREstandard
The old treatment algorithm was applied to all patients with proximal humerus fracture up to May 2013.
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| personal dependency status | 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
| Measure | Time frame | Description |
|---|---|---|
| range of motion | 6 months | — |
| Shoulder pain and disability index (SPADI) | 6 months | 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 |
| SSV | 6 months | 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. |
| General health using EuroQuality of life (EQ)-5D-5L visual analogue scale (VAS) | 6 months | 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. |
| Quality of life (utilities) derived using EQ-5D-5L | 6 months | 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). |
Countries
Switzerland
Outcome results
None listed