Hanover Humerus Registry

Proximal Humerus Fracture Clinical Trial

— HHR  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03060876
• Other study ID #: TS-1MHH2016-HHR
• Status: Recruiting
• Phase: N/A
• First received: June 8, 2016
• Last updated: February 21, 2017
• Start date: June 2016
• Est. completion date: June 2025

Study information

• Verified date: June 2016
• Source: Hannover Medical School
• Contact: Bianca Kramer, B.Sc.
• Phone: +49 511 532 8427
• Email: kramer[@]traumastiftung.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 2025
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Proximal Humerus Fracture

Locations

Country	Name	City	State
Germany	Hanover medical school /trauma surgery	Hanover	Lower Saxony

Sponsors (2)

Lead Sponsor	Collaborator
Hannover Medical School	Traumastiftung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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