Prospective Descriptive Study of Injuries Associated to Anterior Shoulder Dislocations in Patients Over 40 Years

February 6, 2024 updated by: Mònica Salomó Domènech, Corporacion Parc Tauli
The glenohumeral joint has the highest rate of dislocation of the whole body, due to its high mobility and the special characteristics of its anatomy. It is estimated that every year between 1-2% of the population will suffer from glenohumeral dislocation. The vast majority of studies are based on young patients under the age of 40, given that at this age they have the higher incidence and at the same time, they have higher redislocation index. However, the investigators are in front of a more active population with a longer life expectancy. That is why the cases of anterior glenohumeral dislocations are increasing in people older than 40 years. Given that most studies focus on younger patients, the investigators lack knowledge about which injuries are associated with dislocation at this age and whether these influence its clinical evolution.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

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: Mònica Salomó
  • Phone Number: 21611 +34 93 723 10 10
  • Email: msalomo@tauli.cat

Study Contact Backup

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Hospital Parc Tauli
        • Contact:
          • Mireia
          • Phone Number: 21652 34 93 723 10 10

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All consecutive patients with an anterior glenohumeral dislocation and over 40 years old who came to the Emergency Room in the Hospital between June 2023 and June 2025

Description

Inclusion Criteria:

  • More than 40 years old
  • First episode of traumatic anterior gelnohumeral dislocation seen in Rx
  • Acceptance to be checked over 2 years
  • Acceptance to be submitted to TAC, NMR, EMG and Bilateral Ultrasound

Exclusion Criteria:

  • Previous fractures in this extremity
  • Previous neurovascular lesions in this extremity
  • Other associated lesions
  • Cognitive alterations or dementia which prevent completing the protocols. Patients with <14 points in Mini-mental test.

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
Humeral anterior dislocation
Patients presenting a first episode of humeral anterior dislocation and who are over 40 years old.
Procedure: Reduction
An Rx will be performed before and after the reduction of the dislocation. After that, the neurovascular state will be checked and also if there is some associated injury.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Characterization of associated lesions
Time Frame: At the three months visit including assessment of NMR/EMG/TAC/Bilateral Ultrasound
At the three months visit including assessment of NMR/EMG/TAC/Bilateral Ultrasound

Secondary Outcome Measures

Outcome Measure
Time Frame
Constant Functional Test
Time Frame: 3, 6, 12 and 24 months
3, 6, 12 and 24 months
WOSI test
Time Frame: 3, 6, 12 and 24 months
3, 6, 12 and 24 months
SST
Time Frame: 3, 6, 12 and 24 months
3, 6, 12 and 24 months
Redislocations
Time Frame: 3, 6, 12 and 24 months
3, 6, 12 and 24 months
Type of treatment
Time Frame: 3, 6, 12 and 24 months
3, 6, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2023

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

June 1, 2023

First Submitted That Met QC Criteria

June 1, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dislocation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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