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

Shoulder Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05084703
• Other study ID #: 2018-A03013-52
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2019
• Est. completion date: April 26, 2022

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 26, 2022
• Est. primary completion date: April 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Injuries

Intervention

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

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