LatarjetDyScapLatNCT05131126
Influence of an Anterior Latarjet-type Abutment Operation on Scapular Dyskinesia and the Muscular Stabilization Mechanisms of the Scapula (DyScapLat)
A study testing Latarjet method and Different arms exercices in people with Latarjet and Scapular Dyskinesis, 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 the influence of anterior abutment surgery using the Latarjet method on the kinematics of the scapula. The sub-objectives will be to show that Latarjet-type surgery does not lead to scapular dyskinesia and modification of muscle activity compared to a control group that has not… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Latarjet, Scapular Dyskinesis
- What is being tested?
- Latarjet method and Different arms exercices
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 22 May 2019to 22 May 2023
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient Group:
- Male between 18 and 40 years-old
- Practice a regular sports activity before the injury (s) requiring surgery
- Present the clinical criteria leading to anterior abutment surgery using the Latarjet method
- Surgery performed by surgeons from the Jean-Mermoz Private Hospital (69008 Lyon)
- Have followed a post-surgery self-rehabilitation program
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- Control group:
- Male between 18 and 40 years-old
- Practice a regular sports activity
- Both group:
- oPatient having signed an informed consent o Subject affiliated or beneficiary of a social security scheme
Who cannot join
- Patient group:
- Have another shoulder pathology on the side of the operated limb or on the contralateral side
- Present a constitutional hyper laxity
- Have stiffness or recurrence of dislocation of the shoulder post-surgery
- Have a body mass index greater than 30 kg / m² (to ensure sufficient accuracy to measure the movements of the scapula)
- Wear a pacemaker or any other metal device (e.g. patch with metal material)
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- Present a contraindication to the use of measuring devices (intolerance to a weak electromagnetic field)
- Control group:
- Present during the study or have presented in the past any musculoskeletal pathology in the right or left shoulder (WOSI or WORC score greater than 250).
- Have a body mass index greater than 30 kg / m² (to ensure sufficient accuracy to measure the movements of the scapula)
- Wear a pacemaker or any other metal device (e.g. patch with metal material)
- Present a contraindication to the use of measuring devices (intolerance to a weak electromagnetic field)
- Both group :
- o Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
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 the influence of anterior abutment surgery using the Latarjet method on the kinematics of the scapula. The sub-objectives will be to show that Latarjet-type surgery does not lead to scapular dyskinesia and modification of muscle activity compared to a control group that has not undergone an operation.
- Conditions
- Latarjet, Scapular Dyskinesis
- Being tested
- Latarjet method, Different arms exercices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latarjet methodProcedure or surgery
This operation consists of fixing a bone graft
Different arms exercicesOther
Perform 5 elevation movements in each of the elevation planes (sagittal, scapular and coronal) with the right and left arms
- Perform 5 circumduction movements with the right and left arms
- Maintain a weight of 1kg twice for 5 seconds with the arms at 90 ° of elevation.
| Study group | Role | What they receive |
|---|---|---|
| Patient requiring anterior abutment surgery by Latarjet method | Experimental | Not described Receives: Procedure: Latarjet method; Other: Different arms exercices |
| Healthy volunteers | Active comparator | Not described Receives: Other: Different arms exercices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in position of the scapula (tilt, rotation and bell) between the pre and post-test measured in the control group
For electromyographic analysis, the signals will be filtered, smoothed and normalized to obtain a percentage of activation relative to that measured during submaximal voluntary contractions.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start22 May 2019
- Primary completion26 Oct 2021
- Study completion22 May 2023 (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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT05131126
- Sponsor's protocol ID
- 2018-A02449-46
- Acronym
- DyScapLat
- Status last verified
- Nov 2021
- First submitted
- 10 Nov 2021
- Last updated
- 23 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of an Anterior Latarjet-type Abutment Operation on Scapular Dyskinesia and the Muscular Stabilization Mechanisms of the Scapula (DyScapLat)
- ClinicalTrials.gov ID
- NCT05131126
- Acronym / sponsor ID
- DyScapLat / 2018-A02449-46
- Conditions
- Latarjet, Scapular Dyskinesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 22 May 2019 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 22 May 2023 (estimated)
- First posted
- 23 Nov 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 the influence of anterior abutment surgery using the Latarjet method on the kinematics of the scapula. The sub-objectives will be to show that Latarjet-type surgery does not lead to scapular dyskinesia and modification of muscle activity compared to a control group that has not undergone an operation.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient requiring anterior abutment surgery by Latarjet method | Experimental | Procedure: Latarjet method, Other: Different arms exercices |
| Healthy volunteers | Active comparator | Other: Different arms exercices |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Patient Group:
- Male between 18 and 40 years-old
- Practice a regular sports activity
- oPatient having signed an informed consent o Subject affiliated or beneficiary of a social security scheme
Key exclusion criteria (14 listed)
- Have another shoulder pathology on the side of the operated limb or on the contralateral side
- Present a constitutional hyper laxity
- Have stiffness or recurrence of dislocation of the shoulder post-surgery
- Have a body mass index greater than 30 kg / m² (to ensure sufficient accuracy to measure the movements of the scapula)
- Wear a pacemaker or any other metal device (e.g. patch with metal material)
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 |
|---|---|---|
| Latarjet methodThis operation consists of fixing a bone graft | Procedure or surgery | Patient requiring anterior abutment surgery by Latarjet method |
| Different arms exercicesPerform 5 elevation movements in each of the elevation planes (sagittal, scapular and coronal) with the right and left arms * Perform 5 circumduction movements with the right and left arms * Maintain a weight of 1kg twice for 5 seconds with the arms at 90 ° of elevation. | Other | Healthy volunteers, Patient requiring anterior abutment surgery by Latarjet method |
Primary outcome
Difference in position of the scapula (tilt, rotation and bell) between the pre and post-test measured in the control group
Time frame: 4 months
For electromyographic analysis, the signals will be filtered, smoothed and normalized to obtain a percentage of activation relative to that measured during submaximal voluntary contractions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 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 Latarjet method and Different arms exercices in people with Latarjet and Scapular Dyskinesis, 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 11 inclusion and 14 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 23 Nov 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?
Difference in position of the scapula (tilt, rotation and bell) between the pre and post-test measured in the control group (time frame: 4 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 23 Nov 2021.