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

Sponsor
Corporacion Parc Tauli (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05898243
Collaborator
(none)
120
59.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Reduction

Study Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Descriptive Study of Injuries Associated to Anterior Shoulder Dislocations in Patients Over 40 Years
Anticipated Study Start Date :
Jun 15, 2023
Anticipated Primary Completion Date :
May 31, 2028
Anticipated Study Completion Date :
May 31, 2028

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Characterization of associated lesions [At the three months visit including assessment of NMR/EMG/TAC/Bilateral Ultrasound]

Secondary Outcome Measures

  1. Constant Functional Test [3, 6, 12 and 24 months]

  2. WOSI test [3, 6, 12 and 24 months]

  3. SST [3, 6, 12 and 24 months]

  4. Redislocations [3, 6, 12 and 24 months]

  5. Type of treatment [3, 6, 12 and 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Corporacion Parc Tauli

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mònica Salomó Domènech, Doctor, Corporacion Parc Tauli
ClinicalTrials.gov Identifier:
NCT05898243
Other Study ID Numbers:
  • Dislocation
First Posted:
Jun 12, 2023
Last Update Posted:
Jun 16, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 16, 2023