Humeral Fracture, ProximalNCT03023956
Outcome of Proximal Humerus Fractures :Anatomic Neck Fractures vs Surgical Neck Fractures
An observational study of Humeral Fracture, Proximal and Internal Fixation; Complications, Mechanical, Bones of Limb, run by Xiaoxiao Zhou.
Trial summary
From April ,2014 to April 2015,31 patients with fractures of the proximal humerus were treated in our hospital. According to anatomic neck fractures (ANF) and surgical neck fractures (SNF), we divided the patients into two groups. All the patients were followed at least 1 year. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Humeral Fracture, Proximal, Internal Fixation; Complications, Mechanical, Bones of Limb
- What is being tested?
- Locking plates were used for proximal humeral fractures.
- Type of treatment
- Surgery or procedure
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to 3 Jan 2017
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From May ,2013 to April 2015, patients with fractures of the proximal humerus who were treated with locking plate.
Who may be able to join
- -From May ,2013 to April 2015, patients with fractures of the proximal humerus who were treated with locking plate.
Who cannot join
- Patients had pathologic fractures,
- Patients had previous surgery on the affected shoulder,
- Patients were treated with shoulder arthroplasty.
- Patients were treated with intramedullary nail.
About this study
From April ,2014 to April 2015,31 patients with fractures of the proximal humerus were treated in our hospital. According to anatomic neck fractures (ANF) and surgical neck fractures (SNF), we divided the patients into two groups. All the patients were followed at least 1 year.
- Being tested
- Locking plates were used for proximal humeral fractures.
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locking plates were used for proximal humeral fractures.Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| ANF | anatomic neck fractures of proximal humerus Receives: Procedure: Locking plates were used for proximal humeral fractures. | |
| SNF | surgical neck fractures of proximal humerus Receives: Procedure: Locking plates were used for proximal humeral fractures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of head-shaft angle at 12months from 6months in two groups
Measured: 12months
Secondary outcomes (3)
change of Offset at 12months from 6months in two groups
Measured: 12 months
Constant-Murly scores at 3 months, 12 months and last follow-up
Measured: 3 months,12 months,last follow-up (last follow-up means recent evaluation before database lock, it is more than 12months )
change of the distance between the screw tip and the subchondral surface(TSD) at 12months from 6months in two groups
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startJul 2016
- Primary completionDec 2016
- Study completion3 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humeral Fracture, ProximalStudies 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
- Retrospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiaoxiao Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaoxiao Zhou, Zhoupu Hospital, Pudong New Area, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023956
- Sponsor's protocol ID
- ZhouXuANFSNF
- Status last verified
- Jan 2017
- First submitted
- 12 Jan 2017
- Last updated
- 24 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Proximal Humerus Fractures :Anatomic Neck Fractures vs Surgical Neck Fractures
- ClinicalTrials.gov ID
- NCT03023956
- Acronym / sponsor ID
- ZhouXuANFSNF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Xiaoxiao ZhouUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- 3 Jan 2017 (actual)
- First posted
- 18 Jan 2017 (estimated)
- 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.
From April ,2014 to April 2015,31 patients with fractures of the proximal humerus were treated in our hospital. According to anatomic neck fractures (ANF) and surgical neck fractures (SNF), we divided the patients into two groups. All the patients were followed at least 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANF | – | Procedure: Locking plates were used for proximal humeral fractures.anatomic neck fractures of proximal humerus |
| SNF | – | Procedure: Locking plates were used for proximal humeral fractures.surgical neck fractures of proximal humerus |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From May ,2013 to April 2015, patients with fractures of the proximal humerus who were treated with locking plate.
Key inclusion criteria (1 listed)
- -From May ,2013 to April 2015, patients with fractures of the proximal humerus who were treated with locking plate.
Key exclusion criteria (4 listed)
- Patients had pathologic fractures,
- Patients had previous surgery on the affected shoulder,
- Patients were treated with shoulder arthroplasty.
- Patients were treated with intramedullary nail.
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 |
|---|---|---|
| Locking plates were used for proximal humeral fractures. | Procedure or surgery | ANF, SNF |
Primary outcome
change of head-shaft angle at 12months from 6months in two groups
Time frame: 12months
3 secondary outcomes
change of Offset at 12months from 6months in two groups
Time frame: 12 months
Constant-Murly scores at 3 months, 12 months and last follow-up
Time frame: 3 months,12 months,last follow-up (last follow-up means recent evaluation before database lock, it is more than 12months )
change of the distance between the screw tip and the subchondral surface(TSD) at 12months from 6months in two groups
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Humeral Fracture, Proximal and Internal Fixation; Complications, Mechanical, Bones of Limb, run by Xiaoxiao Zhou.
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 4 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: finished, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of head-shaft angle at 12months from 6months in two groups (time frame: 12months). 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 24 Jan 2017.