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.

NCT05150379 | Unknown

• 1 other identifier: Not yet assigned
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Latarjet; Shoulder Injuries

Outcome Measures

Primary Outcomes (1)

• S-STARTS composite score for each participant

  Score between 0 and 21: * 0: total functional disability * 21: full functional ability

  1 hour

Study Arms (3)

Dominant side shoulder surgery patients

Other: Different exercises with their shoulders; Behavioral: SI-RSI questionnaire

Patients operated on the shoulder on the non-dominant side

Other: Different exercises with their shoulders; Behavioral: SI-RSI questionnaire

Healthy volunteers

Other: Different exercises with their shoulders; Behavioral: SI-RSI questionnaire

Interventions

Different exercises with their shoulders OTHER

* Y Balance Test * Shoulder rotator muscle isometric maximum strength * One handed medicine ball throw * Modified Closed Kinetic Chain Upper Extremity Stability Test

Dominant side shoulder surgery patients; Healthy volunteers; Patients operated on the shoulder on the non-dominant side

SI-RSI questionnaire BEHAVIORAL

French version of Shoulder Instability Return-to-Sport after Injury

Dominant side shoulder surgery patients; Healthy volunteers; Patients operated on the shoulder on the non-dominant side

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• European Clinical Trial Experts Network: collaborator

Study Sites (1)

Hopital privé Jean Mermoz

Lyon, 69008, France

Location

Related Publications (1)

• Rogowski I, Nove-Josserand L, Godeneche A, Colotte P, Franger G, Vigne G, Vieira TD, Blache Y, Neyton L. Functional Deficits After Open Latarjet Procedure and Dominance of the Operated Shoulder: An Analysis of 133 Patients. Am J Sports Med. 2023 Apr;51(5):1277-1285. doi: 10.1177/03635465231156181. Epub 2023 Feb 27.

  PMID: 36847281 DERIVED

MeSH Terms

Conditions

Shoulder Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Jean-François Oudet

CONTACT

0683346567; jf.oudet@ecten.eu

Marie-Hélène Barba

CONTACT

mh.barba@ecten.eu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 9, 2021
• Study Start: December 5, 2021
• Primary Completion: June 5, 2022
• Study Completion: December 5, 2022
• Last Updated: December 9, 2021

Record last verified: 2021-11

Locations

FR (1)