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

NCT05084703 | Unknown

• 1 other identifier: 2018-A03013-52
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Latarjet; Shoulder Injuries

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Patients operated for previous shoulder instability

EXPERIMENTAL

Different functionnal test to be done

Other: Functional tests

Healthy volunteer

ACTIVE COMPARATOR

Different functionnal test to be done

Other: Functional tests

Interventions

Functional tests OTHER

* 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

Healthy volunteer; Patients operated for previous shoulder instability

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Hopital privé Jean Mermoz

Lyon, 69008, France

RECRUITING

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: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 20, 2021
• Study Start: April 26, 2019
• Primary Completion: April 26, 2021
• Study Completion: April 26, 2022
• Last Updated: October 20, 2021

Record last verified: 2021-10

Locations

FR (1)