Proximal Humeral FracturesNCT06354894
Percutaneous Pinning Versus Plate and Screws for Surgical Fixation of Proximal Humeral Fractures
An observational study of Proximal Humeral Fractures, run by University of Turin, Italy at 1 site in Italy.
Trial summary
The aim of this multicenter nonrandomised study is to prospectively compare the clinical and radiographic results of two different techniques of surgical fixation of proximal humeral fractures: percutaneous pinning versus plate and screws. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proximal Humeral Fractures
- What is being tested?
- Proximal humeral fracture fixation
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2020to 1 Nov 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by proximal humeral fractures who consent to participate the study and whose fracture was considered to be treated with surgical fixation either with percutaneous pinning or with plate and screws
Who may be able to join
- \> 18 year old
- proximal humeral fracture
- both X-rays and CT scan available
Who cannot join
- dementia
- psychiatric disease
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
San Luigi Gonzaga Hospital
Orbassano, Turin, 10043
Enrico Bellato, MD, +393406429207, enrico.bellato@unito.it
About this study
Official title: Riduzione e Sintesi Delle Fratture Del Terzo Prossimale d'Omero: Confronto Prospettico Tra Placca e Viti e Pinning Percutaneo
The aim of this multicenter nonrandomised study is to prospectively compare the clinical and radiographic results of two different techniques of surgical fixation of proximal humeral fractures: percutaneous pinning versus plate and screws.
- Conditions
- Proximal Humeral Fractures
- Being tested
- Proximal humeral fracture fixation
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal humeral fracture fixationDevice
percutaneous pinning VS plate and screws
| Study group | Role | What they receive |
|---|---|---|
| Patients affected by proximal humeral fracture | Not described Receives: Device: Proximal humeral fracture fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Shoulder Score (OSS)
Patient reported outcome. Score from 0 to 48 points (with the higher score being the better)
Measured: 1 year
Quick Disabilities of the arm, shoulder and hand (DASH) score
The questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms ranging from 0 (no disability) to 100 (most severe disability)
Measured: 1 year
Subjective Shoulder Value (SSV)
The subjective shoulder value is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder during ADLs (from 0% to 100%, with the higher score being the better)
Measured: 1 year
Radiographic outcomes
Shoulder x-rays will be reviewed by a panel of experts in shoulder traumatology who will be asked to define the result as:
- normal
- nonunion
- malunion
- avascular necrosis
- infection
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Nov 2020
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Humeral FracturesStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354894
- Sponsor's protocol ID
- MACOXS
- Other IDs
- 133/2020/U
- Status last verified
- Apr 2024
- First submitted
- 18 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Riduzione e Sintesi Delle Fratture Del Terzo Prossimale d'Omero: Confronto Prospettico Tra Placca e Viti e Pinning Percutaneo
- ClinicalTrials.gov ID
- NCT06354894
- Acronym / sponsor ID
- MACOXS
- Conditions
- Proximal Humeral Fractures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 9 Apr 2024 (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.
The aim of this multicenter nonrandomised study is to prospectively compare the clinical and radiographic results of two different techniques of surgical fixation of proximal humeral fractures: percutaneous pinning versus plate and screws.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients affected by proximal humeral fracture | – | Device: Proximal humeral fracture fixation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by proximal humeral fractures who consent to participate the study and whose fracture was considered to be treated with surgical fixation either with percutaneous pinning or with plate and screws
Key inclusion criteria (3 listed)
- \> 18 year old
- proximal humeral fracture
- both X-rays and CT scan available
Key exclusion criteria (2 listed)
- dementia
- psychiatric disease
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 humeral fracture fixationpercutaneous pinning VS plate and screws | Device | Patients affected by proximal humeral fracture |
Primary outcome
Oxford Shoulder Score (OSS)
Time frame: 1 year
Patient reported outcome. Score from 0 to 48 points (with the higher score being the better)
Quick Disabilities of the arm, shoulder and hand (DASH) score
Time frame: 1 year
The questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms ranging from 0 (no disability) to 100 (most severe disability)
Subjective Shoulder Value (SSV)
Time frame: 1 year
The subjective shoulder value is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder during ADLs (from 0% to 100%, with the higher score being the better)
Radiographic outcomes
Time frame: 1 year
Shoulder x-rays will be reviewed by a panel of experts in shoulder traumatology who will be asked to define the result as: * normal * nonunion * malunion * avascular necrosis * infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
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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.
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 Humeral Fractures, run by University of Turin, Italy at 1 site in Italy.
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 2 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 9 Apr 2024. 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 Italy. 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 Enrico Bellato, MD (+393406429207, enrico.bellato@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Shoulder Score (OSS) (time frame: 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?
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 9 Apr 2024.