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.

Shoulder Injuries Clinical Trial

— Dom Lat  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05150379
• Other study ID #: Not yet assigned
• Status: Not yet recruiting
• Start date: December 5, 2021
• Est. completion date: December 5, 2022

Study information

• Verified date: November 2021
• Source: Ramsay Générale de Santé
• Contact: Jean-François Oudet
• Phone: 0683346567
• Email: jf.oudet[@]ecten.eu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: December 5, 2022
• Est. primary completion date: June 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 45 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Shoulder Injuries

Intervention

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

Locations

Country	Name	City	State
France	Hopital privé Jean Mermoz	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	S-STARTS composite score for each participant	Score between 0 and 21: 0: total functional disability; 21: full functional ability	1 hour