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)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Proximal Humerus Fracture
- Sponsor
- Hannover Medical School
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Constant Shoulder Score (CS) (change over time)
- Status
- Recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Constant Shoulder Score (CS) (change over time)
Time Frame: 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
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.
DASH (change over time)
Time Frame: 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
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.
Health related quality of life: EuroQoL (EQ-5D-3L+5L) (change over time)
Time Frame: 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
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).
Subjective Shoulder Value (SSV) (change over time)
Time Frame: 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
The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.
Secondary Outcomes
- healing process (change over time)(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(Baseline week 1)