Reproducibility of Functional Shoulder Tests for the Return to Sport of Patients Operated on Previous Shoulder Instability

The aim of this study is to assess whether the indicators outcome of these tests discriminate between different populations. In particular to compare populations with shoulders without any history of injury with a population that had undergone a reduction in glenohumeral instability by the Latarjet technique.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Injuries; Latarjet
• Intervention / Treatment: Other: Functional tests

Detailed Description

The different objectives of this study are :

• To assess the intra- and intersessional reproducibility of functional shoulder tests
• To evaluate the influence of an anterior front stop using the Latarjet method on the functional profile of the shoulder compared to a healthy population.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69008
    • Recruiting
    • Hopital Prive Jean Mermoz
    • Contact: Lionel Neyton, Dr; Phone Number: 04 37 53 00 57; Email: neyton.lionel@orange.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

Patient group :

• Male patient
• Between 18 and 30 years-old
• Occurrence of the injury requiring surgery during a sports activity
• Reduction of shoulder instability by the Latarjet technique
• Surgery performed by surgeon from Santy orthopedic center (Lyon)
• Patient's inclusion by decision of the surgeon during the 4 months postoperatively visit

Healthy volunteer group :

• Male patient
• Between 18 and 30 years-old
• Patient regularly practicing sport activity.

Both groups :

• Patient having signed an informed consent
• Affiliated subject or beneficiary of a social security scheme

Exclusion Criteria:

Patient group :

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

Healthy volunteer group :

• Report a history of upper extremity pain / injury within the past 12 months
• Report a history of orthopedic surgery on the upper limbs

All participants :

• Protected subject : adult under guardianship, guardianship or other legal protection, deprived of liberty by judicial or administrative decision
• pregnant woman, breastfeeding, parturient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients operated for previous shoulder instability; Different functionnal test to be done	Other: Functional tests; Symmetry indices between the two limbs obtained thanks to the scores of the functional tests : Y balance test; Muscle endurance index obtained from functional test scores : Closed Kinetic Chain Upper Extremitie Stability test
Active Comparator: Healthy volunteer; Different functionnal test to be done	Other: Functional tests; Symmetry indices between the two limbs obtained thanks to the scores of the functional tests : Y balance test; Muscle endurance index obtained from functional test scores : Closed Kinetic Chain Upper Extremitie Stability test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symmetry indices between the two limbs obtained thanks to the scores of the functional tests	using the Y balance test	1 hour
Muscle endurance index obtained from functional test scores	Using : Closed Kinetic Chain Upper Extremitie Stability test	1 hour

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2019
• Primary Completion (Actual): April 26, 2021
• Study Completion (Anticipated): April 26, 2022

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: October 6, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 6, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries
• Other Study ID Numbers: 2018-A03013-52

Drug and device information, study documents

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