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CompletedNCT05010278ERASMEUpdated Jul 1, 2024

Evaluation of Factors Associated With Return to Sports Activity Six Months After Anterior Shoulder Stabilisation With Latarjet.

An observational study in Shoulder Luxation, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-01.

Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
118
Ages
18 Years and older
Sex
All
01

Study summary

On a population of sports patients who had undergone a Latarjet operation for post-traumatic anterior shoulder instability, reviewed in consultation 6 months after the operation as part of an ordinary follow-up and divided into two groups according to their current sports practice.

Group 1: "SUCCESS": return to the same level in the same sport. Group 2: "FAILURE": return to the same sport with a reduced level or change of sport or significant reduction or cessation of sporting activity.

Read the detailed description

Primary objective:

to assess the impact of patients' psychological state on failure to return to sport.

Secondary objectives:

  • To compare the functional assessment of the shoulder of patients for whom return to sport is successful or unsuccessful (Walch score, isokinetic tests and CKCUES Test score)
  • To describe the factors associated with failure to return to sport
02

Conditions studied

  • Shoulder Luxation

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03

In context

Shoulder Dislocation

104 studies on the registry are indexed under Shoulder Dislocation; 21 are open to participants now.

This study's enrollment of 118 is above the median of 86 across 28 observational studies indexed under Shoulder Dislocation.

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Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 204 studies on the registry; 97 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients followed up 6 months after a Latarjet procedure.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient aged 18 years or older, having been informed of the research
  • Sports patients who have expressed their desire to resume their sporting activity
  • Patient who has undergone a first intention Latarjet operation
  • Patient regularly monitored since the operation and for whom all the data collected during the six-month follow-up visit are available

Exclusion criteria

Exclusion Criteria:

  • Patient operated for revision surgery
  • Patient with an associated rotator cuff or biceps injury
  • Patient under court protection, guardianship or curatorship
  • Patient who has indicated his opposition to the use of his medical data (by completing and returning the non-opposition form which will be sent to him)
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
118 participants (actual)
Patient registry
No

Groups and cohorts

  • Latarjet

    Patients followed up 6 months after a Latarjet procedure

    Procedure: Latarjet

Interventions

  • ProcedureLatarjet

    Patients followed up 6 months after a Latarjet procedure

06

What researchers measure

Primary outcomes

  1. SISRI score

    The Shoulder Instability-Return to Sport after Injury (SIRSI) score will be compared between groups by a Student's t test or by a non-parametric Mann-Whitney test.

    Time frame: 6 months

Secondary outcomes

  1. Walch-Duplay Score for Instability of the Shoulder

    Walch-Duplay Score for Instability of the Shoulder

    Time frame: 6 months

  2. Isokinetic test: peak force

    peak force (in newton-metre)

    Time frame: 6 months

  3. Isokinetic test: relative peak force

    relative peak force: peak force/body weight (in newton/kilogram)

    Time frame: 6 months

  4. Isokinetic test: eccentric peak force

    eccentric peak force achieved in external stroke

    Time frame: 6 months

  5. Closed kinetic chain upper extremity stability (CKCUES) test

    The Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST) is a tool developed and used in the clinic to evaluate progress during upper extremity rehabilitation. A need exists for reference values of CKCUEST for use in a clinical setting.

    Time frame: 6 months

07

Study locations

1 site
  • Clinique du Sport
    Paris, 75005, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05010278
Responsible party
Sponsor
First posted
Aug 18, 2021
Start date
Sep 30, 2021
Primary completion
Jan 31, 2022
Completion
Jan 31, 2022
Last update
Jul 1, 2024

Study contacts

Alexandre HARDY, MD
principal investigator · Clinique du sport

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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