- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04651543
X-Ray Follow-up in Proximal Humeral Fractures Conservatively Treated
March 30, 2022 updated by: Carlos Torrens, Hospital del Mar
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.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Carlos Torrens, PhD
- Phone Number: 3136 0034932483136
- Email: 86925@parcdesalutmar.cat
Study Locations
-
-
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Barcelona, Spain, 08003
- Recruiting
- Parc de Salut Mar
-
Contact:
- Carlos Torrens, MD
- Phone Number: +00609753620
- Email: CTorrens@psmar.cat
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with proximal humeral fractures
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- dementia
- impossibility of carrying out a rehabilitation guideline.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
no control X-Ray
patients with a proximal humeral fracture without one-week X-Ray control
|
X-ray obtained at one-week of the fracture
|
one-week X-Ray control
patients with a proximal humeral fracture with one-week X-Ray control
|
X-ray obtained at one-week of the fracture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Constant Score (0-100 were 100 is the higher outcomes mean better outcomes)
Time Frame: 2 years
|
shoulder functional outcome score
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2020
Primary Completion (Anticipated)
November 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
November 26, 2020
First Submitted That Met QC Criteria
December 2, 2020
First Posted (Actual)
December 3, 2020
Study Record Updates
Last Update Posted (Actual)
April 8, 2022
Last Update Submitted That Met QC Criteria
March 30, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 102020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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