Influence of the Dominance of the Shoulder Stabilized by the Open Latarjet Procedure on the Functional Recovery of the Shoulder at 4.5 Months Postoperatively. (Dom Lat)

Influence of the Dominance of the Shoulder Stabilized by the Open Latarjet Procedure on the Functional Recovery of the Shoulder at 4.5 Months Postoperatively: Patients Operated on the Dominant Side vs. Patients Operated on the Non-dominant Side vs. Healthy Controls

The aim of this study is to quantify the functional deficits as a function of the dominance of the shoulder stabilized by the open procedure of Latarjet at 4.5 months postoperatively compared to healthy controls.

Study Overview

• Status: Not yet recruiting
• Conditions: Shoulder Injuries; Latarjet
• Intervention / Treatment: Other: Different exercises with their shoulders; Behavioral: SI-RSI questionnaire

• Study Type: Observational
• Enrollment (Anticipated): 162

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69008
    • Hôpital Privé Jean Mermoz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient and healthy volunteers between 15 and 45 years old. Patients have an operated shoulder following an injury during a sport activity.

Description

• Patients from two studies : "Reproducibility of functional tests of the shoulder for the return to sport of patients operated on anterior instability of the shoulder "CPP n ° 2018-A03013-52 and "Validation of the S-STARTS composite score to assess the functions of the shoulder and the patient's ability to return to sport after stabilization of the shoulder by the Latarjet procedure (VAL-S-STARTS)" MR3016020520
• healthy volunteers from two studies : "Reproducibility of functional tests of the shoulder for the return to sport of patients operated on anterior instability of the shoulder "CPP n ° 2018-A03013-52" and "Risk factors for shoulder dislocation in rugby players. Predictive validity of the S-STARTS composite score "MR4612110620

Inclusion criteria:

Patients: o patient between 15 and 45 years old

• Occurrence of the injury requiring surgery during a sports activity
• Reduced shoulder instability by the open Latarjet procedure
• Surgery performed by surgeons from the Santy Orthopedic Center (Lyon)
• Inclusion by decision of the surgeon during the visit 4 months postoperatively

Healthy volunteers :

• volunteer between 15 and 45 years old
• Practice a regular sporting activity

Both groups:

• Patient having signed an informed consent
• Subject affiliated or beneficiary of a social security scheme

Exclusion Criteria:

Patient group:

• Contraindication of the surgeon
• Have another pathology in the upper limbs
• Present a constitutional hyperlaxity
• Have stiffness or recurrence of dislocation of the shoulder post-surgery

Healthy volunteers :

• Medical history of upper limb pain / injury within the past 12 months
• Medical history of orthopedic surgery on the upper limbs

Both groups:

• Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy volunteers	Other: Different exercises with their shoulders; Y Balance Test; Shoulder rotator muscle isometric maximum strength; One handed medicine ball throw; Modified Closed Kinetic Chain Upper Extremity Stability Test; Behavioral: SI-RSI questionnaire; French version of Shoulder Instability Return-to-Sport after Injury
Dominant side shoulder surgery patients	Other: Different exercises with their shoulders; Y Balance Test; Shoulder rotator muscle isometric maximum strength; One handed medicine ball throw; Modified Closed Kinetic Chain Upper Extremity Stability Test; Behavioral: SI-RSI questionnaire; French version of Shoulder Instability Return-to-Sport after Injury
Patients operated on the shoulder on the non-dominant side	Other: Different exercises with their shoulders; Y Balance Test; Shoulder rotator muscle isometric maximum strength; One handed medicine ball throw; Modified Closed Kinetic Chain Upper Extremity Stability Test; Behavioral: SI-RSI questionnaire; French version of Shoulder Instability Return-to-Sport after Injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
S-STARTS composite score for each participant	Score between 0 and 21: 0: total functional disability; 21: full functional ability	1 hour

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: European Clinical Trial Experts Network

Study record dates

Study Major Dates

• Study Start (Anticipated): December 5, 2021
• Primary Completion (Anticipated): June 5, 2022
• Study Completion (Anticipated): December 5, 2022

Study Registration Dates

• First Submitted: November 25, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): December 9, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries
• Other Study ID Numbers: not yet assigned (Other Identifier: Istanbul Education and Research Hospital)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No