Shoulder LuxationERASMENCT05010278
Evaluation of Factors Associated With Return to Sports Activity Six Months After Anterior Shoulder Stabilisation With Latarjet.
An observational study of Shoulder Luxation, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
On a population of sports patients who had undergone a Latarjet operation for post-traumatic anterior shoulder instability, reviewed in consultation 6 months after the operation as part of an ordinary follow-up and divided into two groups according to their current sports practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Luxation
- What is being tested?
- Latarjet
- Type of treatment
- Surgery or procedure
- How many people
- 118 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2021to 31 Jan 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients followed up 6 months after a Latarjet procedure.
Who may be able to join
- Patient aged 18 years or older, having been informed of the research
- Sports patients who have expressed their desire to resume their sporting activity
- Patient who has undergone a first intention Latarjet operation
- Patient regularly monitored since the operation and for whom all the data collected during the six-month follow-up visit are available
Who cannot join
- Patient operated for revision surgery
- Patient with an associated rotator cuff or biceps injury
- Patient under court protection, guardianship or curatorship
- Patient who has indicated his opposition to the use of his medical data (by completing and returning the non-opposition form which will be sent to him)
Trial locations and contacts
1 site in 1 country.
About this study
On a population of sports patients who had undergone a Latarjet operation for post-traumatic anterior shoulder instability, reviewed in consultation 6 months after the operation as part of an ordinary follow-up and divided into two groups according to their current sports practice.
Group 1: "SUCCESS": return to the same level in the same sport. Group 2: "FAILURE": return to the same sport with a reduced level or change of sport or significant reduction or cessation of sporting activity.
Read the detailed description
Primary objective:
to assess the impact of patients' psychological state on failure to return to sport.
Secondary objectives:
- To compare the functional assessment of the shoulder of patients for whom return to sport is successful or unsuccessful (Walch score, isokinetic tests and CKCUES Test score)
- To describe the factors associated with failure to return to sport
- Conditions
- Shoulder Luxation
- Being tested
- Latarjet
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LatarjetProcedure or surgery
Patients followed up 6 months after a Latarjet procedure
| Study group | Role | What they receive |
|---|---|---|
| Latarjet | Patients followed up 6 months after a Latarjet procedure Receives: Procedure: Latarjet |
What is being measured
The primary outcome is the main question the study is designed to answer.
SISRI score
The Shoulder Instability-Return to Sport after Injury (SIRSI) score will be compared between groups by a Student's t test or by a non-parametric Mann-Whitney test.
Measured: 6 months
Secondary outcomes (5)
Walch-Duplay Score for Instability of the Shoulder
Walch-Duplay Score for Instability of the Shoulder
Measured: 6 months
Isokinetic test: peak force
peak force (in newton-metre)
Measured: 6 months
Isokinetic test: relative peak force
relative peak force: peak force/body weight (in newton/kilogram)
Measured: 6 months
Isokinetic test: eccentric peak force
eccentric peak force achieved in external stroke
Measured: 6 months
Closed kinetic chain upper extremity stability (CKCUES) test
The Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST) is a tool developed and used in the clinic to evaluate progress during upper extremity rehabilitation. A need exists for reference values of CKCUEST for use in a clinical setting.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start30 Sep 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder LuxationStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre HARDY, MD, Principal investigator, Clinique du sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010278
- Sponsor's protocol ID
- COS-RGDS-2020-06-024
- Acronym
- ERASME
- Status last verified
- Jun 2024
- First submitted
- 16 Aug 2021
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Factors Associated With Return to Sports Activity Six Months After Anterior Shoulder Stabilisation With Latarjet.
- ClinicalTrials.gov ID
- NCT05010278
- Acronym / sponsor ID
- ERASME / COS-RGDS-2020-06-024
- Conditions
- Shoulder Luxation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 18 Aug 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.
On a population of sports patients who had undergone a Latarjet operation for post-traumatic anterior shoulder instability, reviewed in consultation 6 months after the operation as part of an ordinary follow-up and divided into two groups according to their current sports practice.
Group 1: "SUCCESS": return to the same level in the same sport. Group 2: "FAILURE": return to the same sport with a reduced level or change of sport or significant reduction or cessation of sporting activity.
Detailed description
Primary objective:
to assess the impact of patients' psychological state on failure to return to sport.
Secondary objectives:
- To compare the functional assessment of the shoulder of patients for whom return to sport is successful or unsuccessful (Walch score, isokinetic tests and CKCUES Test score)
- To describe the factors associated with failure to return to sport
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Latarjet | – | Procedure: LatarjetPatients followed up 6 months after a Latarjet procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed up 6 months after a Latarjet procedure.
Key inclusion criteria (4 listed)
- Patient aged 18 years or older, having been informed of the research
- Sports patients who have expressed their desire to resume their sporting activity
- Patient who has undergone a first intention Latarjet operation
- Patient regularly monitored since the operation and for whom all the data collected during the six-month follow-up visit are available
Key exclusion criteria (4 listed)
- Patient operated for revision surgery
- Patient with an associated rotator cuff or biceps injury
- Patient under court protection, guardianship or curatorship
- Patient who has indicated his opposition to the use of his medical data (by completing and returning the non-opposition form which will be sent to him)
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 |
|---|---|---|
| LatarjetPatients followed up 6 months after a Latarjet procedure | Procedure or surgery | Latarjet |
Primary outcome
SISRI score
Time frame: 6 months
The Shoulder Instability-Return to Sport after Injury (SIRSI) score will be compared between groups by a Student's t test or by a non-parametric Mann-Whitney test.
5 secondary outcomes
Walch-Duplay Score for Instability of the Shoulder
Time frame: 6 months
Isokinetic test: peak force
Time frame: 6 months
Isokinetic test: relative peak force
Time frame: 6 months
Isokinetic test: eccentric peak force
Time frame: 6 months
Closed kinetic chain upper extremity stability (CKCUES) test
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Alexandre HARDY, MD principal investigator
Clinique du sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Luxation, 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 1 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SISRI score (time frame: 6 months). 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 1 Jul 2024.