Hanover Humerus Registry

Recruiting

• Conditions: Proximal Humerus Fracture

• Registration Number: NCT03060876
• Lead Sponsor: Hannover Medical School

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.

Study Timeline

• Status Verified: 2016-06
• Study Start: 2016-06
• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2017-02-21
• Last Update Submitted: 2017-02-21
• Study First Posted: 2017-02-23
• Last Update Posted: 2017-02-23
• Primary Completion: 2021-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Constant Shoulder Score (CS) (change over time)	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)	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)	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)	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 Outcome Measures

Name	Time	Method
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	Analyzing the radiological imaging for possible dislocation of fracture fragments or other complications
general health conditions	Baseline week 1	Prior disorders of the affected shoulder and secondary diagnosis which are relevant for healing process of the proximal humerus fracture.

Trial Locations

Locations (1)

Hanover medical school /trauma surgery; 🇩🇪 Hanover, Lower Saxony, Germany