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

Shoulder Luxation Clinical Trial

— ERASME  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05010278
• Other study ID #: COS-RGDS-2020-06-024
• Status: Not yet recruiting
• Start date: September 2021
• Est. completion date: January 2022

Study information

• Verified date: August 2021
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Alexandre HARDY, MD
• Phone: 01 86 86 75 05
• Email: alexandre.hardy[@]me.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 118
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Shoulder Dislocation
• Shoulder Luxation

Intervention

Procedure:
• Latarjet
Patients followed up 6 months after a Latarjet procedure

Locations

Country	Name	City	State
France	Clinique du Sport	Paris

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Walch-Duplay Score for Instability of the Shoulder	Walch-Duplay Score for Instability of the Shoulder	6 months
Secondary	Isokinetic test: peak force	peak force (in newton-metre)	6 months
Secondary	Isokinetic test: relative peak force	relative peak force: peak force/body weight (in newton/kilogram)	6 months
Secondary	Isokinetic test: eccentric peak force	eccentric peak force achieved in external stroke	6 months
Secondary	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