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

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Locations

      • Barcelona, Spain, 08003
        • Recruiting
        • Parc de Salut Mar
        • Contact:

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.

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

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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