LatarjetNCT05084703
Reproducibility of Functional Shoulder Tests for the Return to Sport of Patients Operated on Previous Shoulder Instability
A study testing Functional tests in people with Latarjet and Shoulder Injuries, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Latarjet, Shoulder Injuries
- What is being tested?
- Functional tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2019to 26 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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 :
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- 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
Trial locations and contacts
1 site in 1 country.
Marie-Hélène Barba contact
France1 site, 1 recruiting
- Recruiting
Hopital privé Jean Mermoz
Lyon, 69008
Lionel Neyton, Dr, 04 37 53 00 57, neyton.lionel@orange.fr
About this study
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.
Read the 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.
- Conditions
- Latarjet, Shoulder Injuries
- Being tested
- Functional tests
- Medical subject headings
- Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional testsOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| Patients operated for previous shoulder instability | Experimental | Different functionnal test to be done Receives: Other: Functional tests |
| Healthy volunteer | Active comparator | Different functionnal test to be done Receives: Other: Functional tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symmetry indices between the two limbs obtained thanks to the scores of the functional tests
using the Y balance test
Measured: 1 hour
Muscle endurance index obtained from functional test scores
Using : Closed Kinetic Chain Upper Extremitie Stability test
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start26 Apr 2019
- Primary completion26 Apr 2021
- Study completion26 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LatarjetStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084703
- Sponsor's protocol ID
- 2018-A03013-52
- Status last verified
- Oct 2021
- First submitted
- 6 Oct 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of Functional Shoulder Tests for the Return to Sport of Patients Operated on Previous Shoulder Instability
- ClinicalTrials.gov ID
- NCT05084703
- Acronym / sponsor ID
- 2018-A03013-52
- Conditions
- Latarjet, Shoulder Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2022 (estimated)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients operated for previous shoulder instability | Experimental | Other: Functional testsDifferent functionnal test to be done |
| Healthy volunteer | Active comparator | Other: Functional testsDifferent functionnal test to be done |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
- Report a history of upper extremity pain / injury within the past 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Healthy volunteer, Patients operated for previous shoulder instability |
Primary outcome
Symmetry indices between the two limbs obtained thanks to the scores of the functional tests
Time frame: 1 hour
using the Y balance test
Muscle endurance index obtained from functional test scores
Time frame: 1 hour
Using : Closed Kinetic Chain Upper Extremitie Stability test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
Related trials for Latarjet
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Surgical Stabilization of Anterior Shoulder Instability Using the Open Latarjet Procedure, With or Without Anterior Capsuloplasty Using the Coracoacromial Ligament.
Recurrent Anterior Shoulder Instability
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Arthroscopic Stabilization of Anterior Shoulder Instability With Subcritical Glenoid Bone Loss
Anterior Shoulder Instability
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Does Capsuloplasty Reduce External Rotation After Coracoid Impingement?
Shoulder Anterior Latarjet Instability
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Modified PENG Plus Suprascapular Nerve Block Versus Interscalene Block for Bankart and Latarjet Surgery
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Value of Capsular Repair for Latarjet
Shoulder Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Hélène Barba contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional tests in people with Latarjet and Shoulder Injuries, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Oudet (0683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symmetry indices between the two limbs obtained thanks to the scores of the functional tests (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.