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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Luxation
• Intervention / Treatment: Procedure: Latarjet

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

• Study Type: Observational
• Enrollment (Actual): 118

Contacts and Locations

Study Locations

• France
  • Paris, France, 75005
    • Clinique du Sport

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients followed up 6 months after a Latarjet procedure.

Description

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:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Latarjet; Patients followed up 6 months after a Latarjet procedure	Procedure: Latarjet; Patients followed up 6 months after a Latarjet procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walch-Duplay Score for Instability of the Shoulder	Walch-Duplay Score for Instability of the Shoulder	6 months
Isokinetic test: peak force	peak force (in newton-metre)	6 months
Isokinetic test: relative peak force	relative peak force: peak force/body weight (in newton/kilogram)	6 months
Isokinetic test: eccentric peak force	eccentric peak force achieved in external stroke	6 months
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.	6 months

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Investigators: Principal Investigator: Alexandre Hardy, MD, Clinique du Sport

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation
• Other Study ID Numbers: COS-RGDS-2020-06-024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No