OsteoporosisNCT02750839
Influence of Osteoporosis on Clinical Outcomes of Mini-invasive Surgical Treatment of Proximal Humerus Fractures
An observational study of Osteoporosis and Humerus Fracture, run by Azienda Ospedaliera Bolognini di Seriate Bergamo.
Trial summary
Aim of the study is to analyze results of treatment of proximal humerus fractures with mini-invasive technique and plate fixation. In all the patients a analysis of presence of osteoporosis will be done, clinical and x-ray results will be statistically analyzed to evidence any connection between clinical outcomes and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoporosis, Humerus Fracture
- What is being tested?
- proximal humerus fracture fixation
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Apr 2016
- 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, treated with a mini-invasive technique plate.
Who may be able to join
- Proximal humerus fracture
Who cannot join
- High risk to surgery (ASA 4 - 5)
About this study
Aim of the study is to analyze results of treatment of proximal humerus fractures with mini-invasive technique and plate fixation.
In all the patients a analysis of presence of osteoporosis will be done, clinical and x-ray results will be statistically analyzed to evidence any connection between clinical outcomes and osteoporosis.
- Conditions
- Osteoporosis, Humerus Fracture
- Being tested
- proximal humerus fracture fixation
- Medical subject headings
- Osteoporosis, Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proximal humerus fracture fixationProcedure or surgery
Mini-invasive proximal humerus fixation with plate, patient in beach chair position, general anesthesia, a small incision lateral to shoulder is made to insert the plate under scope control
| Study group | Role | What they receive |
|---|---|---|
| proximal humerus fracture | Patients with proximal humerus fracture treated with mini-invasive plate. Receives: Procedure: proximal humerus fracture fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlate osteoporosis (Cortical index) with clinical (Constant score) and radiological (X-ray) results of the procedure
Osteoporosis will be analyzed with the cortical Index, already described in previous articles about this topic. Clinical evaluation will consider the Constant score, the most used functional score for shoulder. X-ray evaluation will analyze the healing of the fracture, studied by a radiologist, and mobilization of the plate or screws. Data will be combined to analyze correlation between clinical results, plate and screws stability and osteoporosis.
Measured: 30 months average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2016
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Bolognini di Seriate Bergamo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riccardo Compagnoni, Azienda Ospedaliera Bolognini di Seriate Bergamo
- Investigators
- Carlo Trevisan, Chief, Study chair, Azienda Ospedaliera Bolognini di Seriate Bergamo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750839
- Sponsor's protocol ID
- Trevisan
- Status last verified
- Apr 2016
- First submitted
- 19 Apr 2016
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Osteoporosis on Clinical Outcomes of Mini-invasive Surgical Treatment of Proximal Humerus Fractures
- ClinicalTrials.gov ID
- NCT02750839
- Acronym / sponsor ID
- Trevisan
- Conditions
- Osteoporosis, Humerus Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Bolognini di Seriate BergamoUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (estimated)
- First posted
- 26 Apr 2016 (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.
Aim of the study is to analyze results of treatment of proximal humerus fractures with mini-invasive technique and plate fixation.
In all the patients a analysis of presence of osteoporosis will be done, clinical and x-ray results will be statistically analyzed to evidence any connection between clinical outcomes and osteoporosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| proximal humerus fracture | – | Procedure: proximal humerus fracture fixationPatients with proximal humerus fracture treated with mini-invasive plate. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with proximal humerus fracture, treated with a mini-invasive technique plate.
Key inclusion criteria (1 listed)
- Proximal humerus fracture
Key exclusion criteria (1 listed)
- High risk to surgery (ASA 4 - 5)
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 |
|---|---|---|
| proximal humerus fracture fixationMini-invasive proximal humerus fixation with plate, patient in beach chair position, general anesthesia, a small incision lateral to shoulder is made to insert the plate under scope control | Procedure or surgery | proximal humerus fracture |
Primary outcome
correlate osteoporosis (Cortical index) with clinical (Constant score) and radiological (X-ray) results of the procedure
Time frame: 30 months average
Osteoporosis will be analyzed with the cortical Index, already described in previous articles about this topic. Clinical evaluation will consider the Constant score, the most used functional score for shoulder. X-ray evaluation will analyze the healing of the fracture, studied by a radiologist, and mobilization of the plate or screws. Data will be combined to analyze correlation between clinical results, plate and screws stability and osteoporosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
- Individual participant dataSharing planned: Undecided
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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.
Carlo Trevisan, Chief study chair
Azienda Ospedaliera Bolognini di Seriate Bergamo
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Humerus Fracture, run by Azienda Ospedaliera Bolognini di Seriate Bergamo.
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 26 Apr 2016. 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?
Results are not available in the source record.
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?
correlate osteoporosis (Cortical index) with clinical (Constant score) and radiological (X-ray) results of the procedure (time frame: 30 months average). 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 26 Apr 2016.