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

NCT ID: NCT05084703

Last Updated: 2021-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-26

Study Completion Date

2022-04-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Latarjet Shoulder Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients operated for previous shoulder instability

Different functionnal test to be done

Group Type EXPERIMENTAL

Functional tests

Intervention Type 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

Different functionnal test to be done

Group Type ACTIVE_COMPARATOR

Functional tests

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

European Clinical Trial Experts Network

OTHER

Sponsor Role collaborator

Ramsay Générale de Santé

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hopital privé Jean Mermoz

Lyon, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jean-François Oudet

Role: CONTACT

0683346567

Marie-Hélène Barba

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lionel Neyton, Dr

Role: primary

04 37 53 00 57

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-A03013-52

Identifier Type: -

Identifier Source: org_study_id