Hanover Humerus Registry (HHR)

February 21, 2017 updated by: Hannover Medical School

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)

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
    • Lower Saxony
      • Hanover, Lower Saxony, Germany
        • Recruiting
        • Hanover medical school /trauma surgery
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with proximal humerus fracture

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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)
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).
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)
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%.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
healing process (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
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
Time Frame: Baseline week 1
Prior disorders of the affected shoulder and secondary diagnosis which are relevant for healing process of the proximal humerus fracture.
Baseline week 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hannover Medical School

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Traumastiftung

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christian Krettek, Prof. Doc., Hanover medical school trauma surgery// trauma foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TS-1MHH2016-HHR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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