Hanover Humerus Registry

Study Overview
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Brief Summary
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This register study collects data of patients with proximal humerus and humerus shaft fractures to monitor the healing process by assessing shoulder function and quality of life according to the treatment method (operative or conservative management).

Detailed Description
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This prospective data collection of patients with proximal humerus and humerus shaft fractures in a lifelong aftercare treatment plan is for analyzing the healing process in one patient and compared in the whole cohort. According to actual scientific and clinical issues can this data collection be a basis in optimizing the treatment method.

Official Title
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Prospective Register Study of Patients After Proximal Humerus and Humerus Shaft Fracture for Data Collection of Healing Process, Quality of Life and Shoulder Function According to the Treatment Method - Hanover Humerus Register (HHR)

Conditions
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Proximal Humerus Fracture

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with trauma-related proximal humerus and humerus shaft fracture cognitively able to fill out a questionaire signed informed consent Exclusion Criteria: patients with oncological-related proximal humerus and humerus shaft fracture cognitively not able to fill out a questionaire no informed consent
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant Shoulder Score (CS) (change over time) | The CS is a commonly used outcome measure for assessing the outcomes of the treatment of shoulder disorders including the pain score, functional assessment, range of motion and strength measures. In week 6, 52 and in the yearly follow ups for comparison reasons the investigators also assess the CS of the not affected shoulder. Reported value is the impaired shoulder-functionality in percent. 100% are equivalent to an unimpaired shoulder function. | following a aftercare treatment plan with follow ups after 6,12, 24, 52 weeks in the first year; then through study completion, an average of 1 year | 
| DASH (change over time) | The Disabilities of the Arm, Shoulder and Hand (DASH) scoring system was developed to assess the level of disability for any patient with any condition affecting the upper limb by covering domains including symptoms, physical function, social function and psychological function. | following a aftercare treatment plan with follow ups after 1,3,6,12, 24, 52 weeks in the first year; then through study completion, an average of 1 year | 
| Health related quality of life: EuroQoL (EQ-5D-3L+5L) (change over time) | The EQ-5D-3L/5L is a standardized instrument for use as a measure of health outcome. It was designed for self-completion covering mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Furthermore, health state is indicated by a Visual Analog Scale (VAS). EQ-5D assesses the health status of the patients in an one-dimensional number (1-3/1-5). | following a aftercare treatment plan with follow ups after 1,3,6,12, 24, 52 weeks in the first year; then through study completion, an average of 1 year | 
| Subjective Shoulder Value (SSV) (change over time) | The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. | following a aftercare treatment plan with follow ups after 1,3,6,12, 24, 52 weeks in the first year; then through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| healing process (change over time) | Analyzing the radiological imaging for possible dislocation of fracture fragments or other complications | following a aftercare treatment plan with follow ups after 1, 3, 6,12, 24, 52 weeks in the first year; then through study completion, an average of 1 year | 
| general health conditions | Prior disorders of the affected shoulder and secondary diagnosis which are relevant for healing process of the proximal humerus fracture. | Baseline week 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shoulder fractures, humeral fractures, operative therapy, conservative therapy, range of motion, articular, quality of life, proximal