Back to results

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

Primary Purpose

Latarjet, Shoulder Injuries

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Functional tests

About this trial

This is an interventional diagnostic trial for Latarjet

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Hopital privé Jean MermozRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients operated for previous shoulder instability

Healthy volunteer

Arm Description

Different functionnal test to be done

Outcomes

Primary Outcome Measures

Symmetry indices between the two limbs obtained thanks to the scores of the functional tests

using the Y balance test

Muscle endurance index obtained from functional test scores

Using : Closed Kinetic Chain Upper Extremitie Stability test

Secondary Outcome Measures

Full Information

NCT ID

NCT05084703

First Posted

October 6, 2021

Last Updated

October 6, 2021

Sponsor

Ramsay Générale de Santé

Collaborators

European Clinical Trial Experts Network

1. Study Identification

Unique Protocol Identification Number

NCT05084703

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 26, 2019 (Actual)

Primary Completion Date

April 26, 2021 (Actual)

Study Completion Date

April 26, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ramsay Générale de Santé

Collaborators

European Clinical Trial Experts Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Latarjet, Shoulder Injuries

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients operated for previous shoulder instability

Arm Type

Experimental

Arm Description

Different functionnal test to be done

Arm Title

Healthy volunteer

Arm Type

Active Comparator

Arm Description

Different functionnal test to be done

Intervention Type

Other

Intervention Name(s)

Functional tests

Intervention Description

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

Primary Outcome Measure Information:

Title

Symmetry indices between the two limbs obtained thanks to the scores of the functional tests

Description

using the Y balance test

Time Frame

1 hour

Title

Muscle endurance index obtained from functional test scores

Description

Using : Closed Kinetic Chain Upper Extremitie Stability test

Time Frame

1 hour

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jean-François Oudet

Phone

0683346567

jf.oudet@ecten.eu

First Name & Middle Initial & Last Name or Official Title & Degree

Marie-Hélène Barba

mh.barba@ecten.eu

Facility Information:

Facility Name

Hopital privé Jean Mermoz

City

Lyon

ZIP/Postal Code

69008

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lionel Neyton, Dr

Phone

04 37 53 00 57

neyton.lionel@orange.fr

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs