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

NCT ID: NCT05898243

Last Updated: 2024-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2028-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anterior Glenohumeral Dislocations

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Humeral anterior dislocation

Patients presenting a first episode of humeral anterior dislocation and who are over 40 years old.

Reduction

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Corporacion Parc Tauli

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mònica Salomó Domènech

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Parc Taulí

Sabadell, Barcelona, Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mònica Salomó

Role: CONTACT

+34 93 723 10 10 ext. 21611

Mireia Viñas

Role: CONTACT

+34 93 723 10 10 ext. 21660

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mireia

Role: primary

34 93 723 10 10 ext. 21652

References

Explore related publications, articles, or registry entries linked to this study.

Smartt AA, Wilbur RR, Song BM, Krych AJ, Okoroha K, Barlow JD, Camp CL. Natural History of First-Time Anterior Shoulder Dislocation in Patients Older Than 50 Years: A Study of 179 Patients With a Mean Follow-up of 11 Years. Orthop J Sports Med. 2022 Nov 2;10(11):23259671221129301. doi: 10.1177/23259671221129301. eCollection 2022 Nov.

Reference Type BACKGROUND
PMID: 36339796 (View on PubMed)

Rapariz JM, Martin-Martin S, Pareja-Bezares A, Ortega-Klein J. Shoulder dislocation in patients older than 60 years of age. Int J Shoulder Surg. 2010 Oct;4(4):88-92. doi: 10.4103/0973-6042.79792.

Reference Type BACKGROUND
PMID: 21655003 (View on PubMed)

Robinson CM, Shur N, Sharpe T, Ray A, Murray IR. Injuries associated with traumatic anterior glenohumeral dislocations. J Bone Joint Surg Am. 2012 Jan 4;94(1):18-26. doi: 10.2106/JBJS.J.01795.

Reference Type BACKGROUND
PMID: 22218378 (View on PubMed)

Maier M, Geiger EV, Ilius C, Frank J, Marzi I. Midterm results after operatively stabilised shoulder dislocations in elderly patients. Int Orthop. 2009 Jun;33(3):719-23. doi: 10.1007/s00264-008-0578-z. Epub 2008 May 24.

Reference Type BACKGROUND
PMID: 18500515 (View on PubMed)

Atef A, El-Tantawy A, Gad H, Hefeda M. Prevalence of associated injuries after anterior shoulder dislocation: a prospective study. Int Orthop. 2016 Mar;40(3):519-24. doi: 10.1007/s00264-015-2862-z. Epub 2015 Jul 2.

Reference Type BACKGROUND
PMID: 26133290 (View on PubMed)

Sonnabend DH. Treatment of primary anterior shoulder dislocation in patients older than 40 years of age. Conservative versus operative. Clin Orthop Relat Res. 1994 Jul;(304):74-7.

Reference Type BACKGROUND
PMID: 8020237 (View on PubMed)

Liavaag S, Stiris MG, Svenningsen S, Enger M, Pripp AH, Brox JI. Capsular lesions with glenohumeral ligament injuries in patients with primary shoulder dislocation: magnetic resonance imaging and magnetic resonance arthrography evaluation. Scand J Med Sci Sports. 2011 Dec;21(6):e291-7. doi: 10.1111/j.1600-0838.2010.01282.x. Epub 2011 Mar 15.

Reference Type BACKGROUND
PMID: 21401723 (View on PubMed)

Stayner LR, Cummings J, Andersen J, Jobe CM. Shoulder dislocations in patients older than 40 years of age. Orthop Clin North Am. 2000 Apr;31(2):231-9. doi: 10.1016/s0030-5898(05)70143-7.

Reference Type BACKGROUND
PMID: 10736392 (View on PubMed)

Shin SJ, Yun YH, Kim DJ, Yoo JD. Treatment of traumatic anterior shoulder dislocation in patients older than 60 years. Am J Sports Med. 2012 Apr;40(4):822-7. doi: 10.1177/0363546511434522. Epub 2012 Jan 27.

Reference Type BACKGROUND
PMID: 22287643 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Dislocation

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Anatomical Shoulder Domelock System Study
NCT03312465 ACTIVE_NOT_RECRUITING
Arthroscopic Subscapularis Augmentation
NCT07292740 NOT_YET_RECRUITING