Proximal Humerus FractureHHRNCT03060876
Hanover Humerus Registry
An observational study of Proximal Humerus Fracture, run by Hannover Medical School at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Proximal Humerus Fracture
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2016to Jun 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with proximal humerus fracture
Who may be able to join
- patients with trauma-related proximal humerus and humerus shaft fracture
- cognitively able to fill out a questionaire
- signed informed consent
Who cannot join
- patients with oncological-related proximal humerus and humerus shaft fracture
- cognitively not able to fill out a questionaire
- no informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Hanover medical school /trauma surgery
Hanover, Lower Saxony
Bianca Kramer, B.Sc., +49 511 532 8427, kramer@traumastiftung.de
About this study
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)
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).
Read the 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.
- Conditions
- Proximal Humerus Fracture
- Keywords
- shoulder fractures, humeral fractures, operative therapy, conservative therapy, range of motion, articular, quality of life, proximal
- Medical subject headings
- Shoulder Fractures, Humeral Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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).
Measured: 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)
The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.
Measured: 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 outcomes (2)
healing process (change over time)
Analyzing the radiological imaging for possible dislocation of fracture fragments or other complications
Measured: 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
Prior disorders of the affected shoulder and secondary diagnosis which are relevant for healing process of the proximal humerus fracture.
Measured: Baseline week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startJun 2016
- Primary completionJun 2021 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Proximal Humerus FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Traumastiftung
- Responsible party
- Sponsor
- Investigators
- Christian Krettek, Prof. Doc., Principal investigator, Hanover medical school trauma surgery// trauma foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060876
- Sponsor's protocol ID
- TS-1MHH2016-HHR
- Acronym
- HHR
- Status last verified
- Jun 2016
- First submitted
- 8 Jun 2016
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Razaeian S, Hawi N, Zhang D, Liodakis E, Krettek C. Conservative treatment of displaced isolated proximal humerus greater tuberosity fractures: preliminary results of a prospective, CT-based registry study. Eur J Trauma Emerg Surg. 2022 Dec;48(6):4531-4543. doi: 10.1007/s00068-020-01453-7. Epub 2020 Sep 15.
PubMed 32930807
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03060876
- Acronym / sponsor ID
- HHR / TS-1MHH2016-HHR
- Conditions
- Proximal Humerus Fracture
- Keywords
- shoulder fractures, humeral fractures, operative therapy, conservative therapy, range of motion, articular, quality of life, proximal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Traumastiftung
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with proximal humerus fracture
Key inclusion criteria (3 listed)
- patients with trauma-related proximal humerus and humerus shaft fracture
- cognitively able to fill out a questionaire
- signed informed consent
Key exclusion criteria (3 listed)
- patients with oncological-related proximal humerus and humerus shaft fracture
- cognitively not able to fill out a questionaire
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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%.
2 secondary outcomes
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
general health conditions
Time frame: Baseline week 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Derived from this study: PubMed 32930807Razaeian S, Hawi N, Zhang D, Liodakis E, Krettek C. Conservative treatment of displaced isolated proximal humerus greater tuberosity fractures: preliminary results of a prospective, CT-based registry study. Eur J Trauma Emerg Surg. 2022 Dec;48(6):4531-4543. doi: 10.1007/s00068-020-01453-7. Epub 2020 Sep 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Krettek, Prof. Doc. principal investigator
Hanover medical school trauma surgery// trauma foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proximal Humerus Fracture, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bianca Kramer, B.Sc. (+49 511 532 8427, kramer@traumastiftung.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03060876, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.