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NCT Number: NCT05898243

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location status: Recruiting

Location contact

Mireia

CONTACT

34 93 723 10 10 ext. 21652

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reduction

Procedure

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.

Primary outcomes

  1. Characterization of associated lesions

    Time frame: At the three months visit including assessment of NMR/EMG/TAC/Bilateral Ultrasound

Secondary outcomes

  1. Constant Functional Test

    Time frame: 3, 6, 12 and 24 months

  2. WOSI test

    Time frame: 3, 6, 12 and 24 months

  3. SST

    Time frame: 3, 6, 12 and 24 months

  4. Redislocations

    Time frame: 3, 6, 12 and 24 months

  5. Type of treatment

    Time frame: 3, 6, 12 and 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Mireia Viñas

CONTACT

[email protected]

+34 93 723 10 10 ext. 21660

Mònica Salomó

CONTACT

[email protected]

+34 93 723 10 10 ext. 21611

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jun 12, 2023
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.