Hanover Humerus Registry

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)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03060876

Acronym

HHR

Enrollment

1000

Registered

2017-02-23

Start date

2016-06-30

Completion date

2025-06-30

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal Humerus Fracture

Keywords

shoulder fractures, humeral fractures, operative therapy, conservative therapy, range of motion, articular, quality of life, proximal

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Germany

Contacts

Primary ContactBianca Kramer, B.Sc.

kramer@traumastiftung.de+49 511 532 8427

Outcome results