Shoulder FracturesNCT04651543
X-Ray Follow-up in Proximal Humeral Fractures Conservatively Treated
An observational study of Shoulder Fractures, run by Hospital del Mar at 1 site in Spain.
Trial summary
Randomly assign patients with fractures of the proximal humerus to conservative treatment to a group in which a control radiological study will be carried out after a week of evolution of the fracture and to another group in which this control radiology will not be carried out. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Shoulder Fractures
- What is being tested?
- X-Ray
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2020to 1 Dec 2022
- How long will I take part?
- 2 Years
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with proximal humeral fractures
Who may be able to join
- patients> 18 yo and < 85 yo
- Fractures of the proximal humerus <3 weeks of evolution.
- fractures treated conservatively.
- No previous pathology of the affected shoulder.
Who cannot join
- dementia
- impossibility of carrying out a rehabilitation guideline.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Parc de Salut Mar
Barcelona, 08003
Carlos Torrens, MD, +00609753620, CTorrens@psmar.cat
About this study
Official title: Is a Follow-up Radiological Study at One Week Necessary in Conservatively Treated Fractures of the Proximal Humerus? Randomized Prospective Study
Randomly assign patients with fractures of the proximal humerus to conservative treatment to a group in which a control radiological study will be carried out after a week of evolution of the fracture and to another group in which this control radiology will not be carried out. In the evolutionary controls, it will be determined whether there are differences between the two groups in the final functional result, in the perception of quality of life, and in the number of complications derived from the fracture.
- Conditions
- Shoulder Fractures
- Being tested
- X-Ray
- Keywords
- proximal humeral fractures, conservative treatment, outcomes
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-RayOther
X-ray obtained at one-week of the fracture
| Study group | Role | What they receive |
|---|---|---|
| no control X-Ray | patients with a proximal humeral fracture without one-week X-Ray control Receives: Other: X-Ray | |
| one-week X-Ray control | patients with a proximal humeral fracture with one-week X-Ray control Receives: Other: X-Ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant Score (0-100 were 100 is the higher outcomes mean better outcomes)
shoulder functional outcome score
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Dec 2020
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hospital del Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Torrens, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651543
- Sponsor's protocol ID
- 102020
- Status last verified
- Mar 2022
- First submitted
- 26 Nov 2020
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is a Follow-up Radiological Study at One Week Necessary in Conservatively Treated Fractures of the Proximal Humerus? Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT04651543
- Acronym / sponsor ID
- 102020
- Conditions
- Shoulder Fractures
- Keywords
- proximal humeral fractures, conservative treatment, outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital del MarUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 3 Dec 2020 (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.
Randomly assign patients with fractures of the proximal humerus to conservative treatment to a group in which a control radiological study will be carried out after a week of evolution of the fracture and to another group in which this control radiology will not be carried out. In the evolutionary controls, it will be determined whether there are differences between the two groups in the final functional result, in the perception of quality of life, and in the number of complications derived from the fracture.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no control X-Ray | – | Other: X-Raypatients with a proximal humeral fracture without one-week X-Ray control |
| one-week X-Ray control | – | Other: X-Raypatients with a proximal humeral fracture with one-week X-Ray control |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with proximal humeral fractures
Key inclusion criteria (4 listed)
- patients> 18 yo and < 85 yo
- Fractures of the proximal humerus <3 weeks of evolution.
- fractures treated conservatively.
- No previous pathology of the affected shoulder.
Key exclusion criteria (2 listed)
- dementia
- impossibility of carrying out a rehabilitation guideline.
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 |
|---|---|---|
| X-RayX-ray obtained at one-week of the fracture | Other | no control X-Ray, one-week X-Ray control |
Primary outcome
Constant Score (0-100 were 100 is the higher outcomes mean better outcomes)
Time frame: 2 years
shoulder functional outcome score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
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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 Shoulder Fractures, run by Hospital del Mar at 1 site in Spain.
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 4 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 8 Apr 2022. 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 Spain. 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 Carlos Torrens, PhD (0034932483136 ext. 3136, 86925@parcdesalutmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant Score (0-100 were 100 is the higher outcomes mean better outcomes) (time frame: 2 years). 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 8 Apr 2022.