Humeral Greater TuberosityNCT03481478
Detecting Occult Proximal Humeral Neck Fractures Through CT and MRI Tests of Patients With Greater Tuberosity Fractures
An observational study of Humeral Greater Tuberosity and Humeral Fractures/ Proximal, run by Hebei Medical University Third Hospital at 1 site in China.
Trial summary
Patients with greater tuberosity fractures is becoming increasingly common, as is the number of cases of humeral surgical neck fractures. This study investigated the relationship between size of greater tuberosity fragment and occurrence of humeral surgical neck fractures by using CT or MRI tests. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Humeral Greater Tuberosity, Humeral Fractures/ Proximal, Fractures/ Occult
- What is being tested?
- CT and MRI
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2018to 31 Dec 2018
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient demographics, comorbidities, injury mechanisms and other variables were recorded and calculated for each case.
Who may be able to join
- Patients 18 years or older with greater tuberosity fractures and shoulder dislocation/ or not who were acute injured were included
Who cannot join
- Patients with ipsilateral previous proximal humeral fractures and obviously proximal humeral fractures were excluded。
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, 050051
Zhiyong Hou, M.D, +8618533112800, houzhiyong1234@126.com
Ruipeng Zhang, M.D
About this study
Official title: Third Hospital of Hebei Medical University
Patients with greater tuberosity fractures is becoming increasingly common, as is the number of cases of humeral surgical neck fractures. This study investigated the relationship between size of greater tuberosity fragment and occurrence of humeral surgical neck fractures by using CT or MRI tests.
Read the detailed description
Some humeral surgical neck fractures can be detected through X-ray of shoulder in patients with greater tuberosity fractures. However, some fractures can not be find through conventional X-ray in such patients unless broader CT or MRI tests are required to confirm diagnoses of humeral surgical neck fractures.
- Being tested
- CT and MRI
- Keywords
- occult, proximal humeral neck fractures, greater tuberosity, shoulder dislocation
- Medical subject headings
- Shoulder Fractures, Fractures, Closed, Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT and MRIDiagnostic test
For such patients, using CT and/or MRI to find if existing humeral surgical neck fractures.
| Study group | Role | What they receive |
|---|---|---|
| Patients with greater tuberosity fractures | If humeral surgical neck fractures can be detected through CT or MRI in such groups. Receives: Diagnostic Test: CT and MRI | |
| Dislocation patients with greater tuberosity fractures | If humeral surgical neck fractures can be detected through CT or MRI in such groups. Receives: Diagnostic Test: CT and MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Humeral surgical neck fractures can be detected through CT/MRI.
Some greater tuberosity fractures with/or not shoulder dislocation can combined with humeral surgical neck fractures,which can be detected through CT/MRI
Measured: 31/12/2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start24 Mar 2018
- Primary completion31 Oct 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humeral Greater TuberosityStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guo Junfei, MD, Study director, Hebei Medical University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481478
- Sponsor's protocol ID
- HZY2018
- Status last verified
- Mar 2018
- First submitted
- 22 Feb 2018
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Third Hospital of Hebei Medical University
- ClinicalTrials.gov ID
- NCT03481478
- Acronym / sponsor ID
- HZY2018
- Keywords
- occult, proximal humeral neck fractures, greater tuberosity, shoulder dislocation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hebei Medical University Third HospitalUniversity, hospital or other
- Study start
- 24 Mar 2018 (actual)
- Primary completion
- 31 Oct 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 29 Mar 2018 (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.
Patients with greater tuberosity fractures is becoming increasingly common, as is the number of cases of humeral surgical neck fractures. This study investigated the relationship between size of greater tuberosity fragment and occurrence of humeral surgical neck fractures by using CT or MRI tests.
Detailed description
Some humeral surgical neck fractures can be detected through X-ray of shoulder in patients with greater tuberosity fractures. However, some fractures can not be find through conventional X-ray in such patients unless broader CT or MRI tests are required to confirm diagnoses of humeral surgical neck fractures.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with greater tuberosity fractures | – | Diagnostic Test: CT and MRIIf humeral surgical neck fractures can be detected through CT or MRI in such groups. |
| Dislocation patients with greater tuberosity fractures | – | Diagnostic Test: CT and MRIIf humeral surgical neck fractures can be detected through CT or MRI in such groups. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient demographics, comorbidities, injury mechanisms and other variables were recorded and calculated for each case.
Key inclusion criteria (1 listed)
- Patients 18 years or older with greater tuberosity fractures and shoulder dislocation/ or not who were acute injured were included
Key exclusion criteria (1 listed)
- Patients with ipsilateral previous proximal humeral fractures and obviously proximal humeral fractures were excluded。
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT and MRIFor such patients, using CT and/or MRI to find if existing humeral surgical neck fractures. | Diagnostic test | Dislocation patients with greater tuberosity fractures, Patients with greater tuberosity fractures |
Primary outcome
Humeral surgical neck fractures can be detected through CT/MRI.
Time frame: 31/12/2018
Some greater tuberosity fractures with/or not shoulder dislocation can combined with humeral surgical neck fractures,which can be detected through CT/MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Individual participant dataSharing planned: Undecided
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.
Guo Junfei, MD study director
Hebei Medical University Third Hospital
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 Humeral Greater Tuberosity and Humeral Fractures/ Proximal, run by Hebei Medical University Third Hospital at 1 site in China.
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 1 inclusion and 1 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 29 Mar 2018. 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 China. 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 Hou Zhiyong, MD (+86 18533112800, drzyhou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Humeral surgical neck fractures can be detected through CT/MRI. (time frame: 31/12/2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2018.