Humeral Fracture, ProximalNCT04821180
Psychological Health Influences the Choice of Device in Proximal Humeral Fractures
An observational study of Humeral Fracture, Proximal, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari.
Trial summary
It was conducted a prospective study with a series of 63 patients treated with O.R.I.F. (Open Reduction and Internal Fixation) (group A) and with RSA (Reverse Shoulder Arthroplasty) (group B) for three and four-part proximal humeral fractures according to Neer classification system. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Humeral Fracture, Proximal
- What is being tested?
- Three and four-part proximal humeral fractures' treatment
- Type of treatment
- Surgery or procedure
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Mar 2021
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Subjects affected by proximal humeral fractures
Who may be able to join
- Three and four-part proximal humeral fractures according to Neer classification system;
- Patients seventy years or older;
- Shoulder surgery within one week after trauma
Who cannot join
- Exposed fractures;
- Pathological fractures;
- Proximal humerus fractures with metaphyseal or diaphyseal extension;
- Contraindications to surgery associated with organ dysfunctions or with coagulopathy;
- Allergy or hypersensitivity to the orthopedic implants;
- Patients who were unable to attend the different follow-ups;
- Patients with psychiatric disorders
About this study
Official title: Angle Stable Plate Versus Reverse Shoulder Treatment for Proximal Humeral Fractures: Should the Psychological Health Influence the Choice of Device
It was conducted a prospective study with a series of 63 patients treated with O.R.I.F. (Open Reduction and Internal Fixation) (group A) and with RSA (Reverse Shoulder Arthroplasty) (group B) for three and four-part proximal humeral fractures according to Neer classification system. One independent observer performed clinical and a psychological evaluation at one(T0), six(T1) and twelve months(T2) postoperatively.
The Constant's score and The Disabilities of the Arm, Shoulder and Hand (DASH score) were used for clinical evaluation, while General Anxiety Disorder-7 (GAD-7) and Caregiver Strain Scale (CSS) were used for psychological evaluation.
- Conditions
- Humeral Fracture, Proximal
- Being tested
- Three and four-part proximal humeral fractures' treatment
- Keywords
- Open reduction and fixation, Reverse shoulder arthroplasty
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three and four-part proximal humeral fractures' treatmentProcedure or surgery
Open Reduction and Internal Fixation with angle stable plate PHILOS versus RSA (Reverse Shoulder Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| patients treated by angle stable plate PHILOS | Not described Receives: Procedure: Three and four-part proximal humeral fractures' treatment | |
| patients treated by reverse total shoulder arthroplasty SMR | Not described Receives: Procedure: Three and four-part proximal humeral fractures' treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Constant's score
The shoulder functionality was quantified using the Constant's score ranging between 0 (most disability) and 100 points (least disability).
Measured: T0 (one-month), T1 (six months), T2 (one year) post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study startJan 2016
- Primary completionJan 2019
- Study completionMar 2021
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
- Other
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821180
- Sponsor's protocol ID
- HUMERUS-PSY
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 29 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angle Stable Plate Versus Reverse Shoulder Treatment for Proximal Humeral Fractures: Should the Psychological Health Influence the Choice of Device
- ClinicalTrials.gov ID
- NCT04821180
- Acronym / sponsor ID
- HUMERUS-PSY
- Conditions
- Humeral Fracture, Proximal
- Keywords
- Open reduction and fixation, Reverse shoulder arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 29 Mar 2021 (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.
It was conducted a prospective study with a series of 63 patients treated with O.R.I.F. (Open Reduction and Internal Fixation) (group A) and with RSA (Reverse Shoulder Arthroplasty) (group B) for three and four-part proximal humeral fractures according to Neer classification system. One independent observer performed clinical and a psychological evaluation at one(T0), six(T1) and twelve months(T2) postoperatively.
The Constant's score and The Disabilities of the Arm, Shoulder and Hand (DASH score) were used for clinical evaluation, while General Anxiety Disorder-7 (GAD-7) and Caregiver Strain Scale (CSS) were used for psychological evaluation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients treated by angle stable plate PHILOS | – | Procedure: Three and four-part proximal humeral fractures' treatment |
| patients treated by reverse total shoulder arthroplasty SMR | – | Procedure: Three and four-part proximal humeral fractures' treatment |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Subjects affected by proximal humeral fractures
Key inclusion criteria (3 listed)
- Three and four-part proximal humeral fractures according to Neer classification system;
- Patients seventy years or older;
- Shoulder surgery within one week after trauma
Key exclusion criteria (7 listed)
- Exposed fractures;
- Pathological fractures;
- Proximal humerus fractures with metaphyseal or diaphyseal extension;
- Contraindications to surgery associated with organ dysfunctions or with coagulopathy;
- Allergy or hypersensitivity to the orthopedic implants;
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 |
|---|---|---|
| Three and four-part proximal humeral fractures' treatmentOpen Reduction and Internal Fixation with angle stable plate PHILOS versus RSA (Reverse Shoulder Arthroplasty | Procedure or surgery | patients treated by angle stable plate PHILOS, patients treated by reverse total shoulder arthroplasty SMR |
Primary outcome
Change in Constant's score
Time frame: T0 (one-month), T1 (six months), T2 (one year) post operatively
The shoulder functionality was quantified using the Constant's score ranging between 0 (most disability) and 100 points (least disability).
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 29 Mar 2021.
- Individual participant dataSharing planned: No. No sharing
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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, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari.
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 7 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 29 Mar 2021. 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 in Constant's score (time frame: T0 (one-month), T1 (six months), T2 (one year) post operatively). 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 2021.