NCT05898243

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
25mo left

Started Jun 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Jun 2023May 2028

First Submitted

Initial submission to the registry

June 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

5 years

First QC Date

June 1, 2023

Last Update Submit

February 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Characterization of associated lesions

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

Secondary Outcomes (5)

  • Constant Functional Test

    3, 6, 12 and 24 months

  • WOSI test

    3, 6, 12 and 24 months

  • SST

    3, 6, 12 and 24 months

  • Redislocations

    3, 6, 12 and 24 months

  • Type of treatment

    3, 6, 12 and 24 months

Study Arms (1)

Humeral anterior dislocation

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

Procedure: Reduction

Interventions

ReductionPROCEDURE

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.

Humeral anterior dislocation

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Parc Taulí

Sabadell, Barcelona, 08208, Spain

RECRUITING

Related Publications (9)

  • 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.

    PMID: 36339796BACKGROUND
  • 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.

    PMID: 21655003BACKGROUND
  • 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.

    PMID: 22218378BACKGROUND
  • 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.

    PMID: 18500515BACKGROUND
  • 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.

    PMID: 26133290BACKGROUND
  • 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.

    PMID: 8020237BACKGROUND
  • 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.

    PMID: 21401723BACKGROUND
  • 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.

    PMID: 10736392BACKGROUND
  • 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.

    PMID: 22287643BACKGROUND

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 1, 2023

First Posted

June 12, 2023

Study Start

June 1, 2023

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2028

Last Updated

February 7, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations