LatarjetISO-LATNCT06602713
Ability of Rotator Cuff Muscle Strength Levels, Assessed by Isokinetic Dynamometry, to Predict Return to Sport After Shoulder Stabilization Surgery by Open Latarjet Procedure
A study testing Questionnaires and Exercices 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 stabilization surgical treatment by open Latarjet procedure is one of the reference treatments after anterior glenohumeral dislocation in athletes. This surgical technique allows low recurrence rates and high return to sport rates. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Latarjet, Shoulder Injuries, Rotator Cuff Injuries
- What is being tested?
- Questionnaires and Exercices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2024to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient group:
- Be aged between 18 and 45
- Occurrence of the injury during the practice of a sporting activity
- Post-traumatic anterior glenohumeral subluxation/dislocation
- Contralateral shoulder with no history of injury
- No other associated shoulder pathology
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- Patient scheduled for shoulder stabilizing surgery using an open Latarjet procedure performed by one of the surgeons at the Santy Orthopedic Center (Lyon)
- No contraindication to isokinetic assessment
- Patient having signed informed consent
- Subject affiliated or beneficiary of a social security scheme
- Healthy volunteers:
- Be aged between 18 and 45
- Regularly practice a sporting activity
- No contraindication to isokinetic assessment
- Person having signed informed consent
- Subject affiliated or beneficiary of a social security scheme
Who cannot join
- Patient group:
- Contraindication from the sports clinician or surgeon
- Have another pathology in the upper limbs.
- Have constitutional hyperlaxity
- Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Healthy volunteer group (athletes without a history of shoulder pathology):
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- Declare a history of pain/injury in the upper limbs in the last 6 months
- Declare a history of orthopedic surgery in the upper limbs
- 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. Contact the study team or a site near you to ask about taking part.
France1 site
Hopital privé Jean Mermoz
Lyon, 69008
Lionel Neyton, Dr, 04 37 53 00 57, secretariat.scientifique@orthosanty.fr
About this study
The stabilization surgical treatment by open Latarjet procedure is one of the reference treatments after anterior glenohumeral dislocation in athletes. This surgical technique allows low recurrence rates and high return to sport rates. Indeed, more than 90% of athletes return to sport after this type of surgery, but only 60% are able to resume the same activity as a preinjury level of performance. Therefore, adaptations in the postoperative management of athletes patients seem necessary. Isokinetic dynamometry is considered the gold standard to provide an objective assessment of muscle strength abilities, particularly in the clinical setting. Although rehabilitation exercises are prescribed early after the Latarjet procedure, muscle deconditioning occurs during the postoperative phase, limiting the abilities of the rotator cuff muscles to provide stability to the glenohumeral joint. Therefore, recovery of all components of strength, i.e. maximal strength, power, and strength endurance of the rotator cuff muscles appears crucial for the athletes to return to their sport at the pre-injury level. However, at present, the strength levels to be recovered remain to be defined.
- Conditions
- Latarjet, Shoulder Injuries, Rotator Cuff Injuries
- Being tested
- Questionnaires, Exercices
- Medical subject headings
- Shoulder Injuries, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Western Ontario Shoulder Instability questionnaire Western Ontario Rotator Cuff questionnaire Shoulder Instability Return to Sport after Injury questionnaire
ExercicesOther
isokinetic evaluation
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Active comparator | Questionnaires and exercices Receives: Other: Questionnaires; Other: Exercices |
| Patient operated at shoulder by open Latarjet procedure | Experimental | Questionnaires and exercices Receives: Other: Questionnaires; Other: Exercices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilateral glenohumeral rotator muscle strength differences assessed at 4 months postoperatively
Bilateral muscle strength gap at 4 months postoperatively:
- concentric internal rotators at 60°/s
- concentric external rotators at 60°/s,
- eccentric internal rotators at 60°/s,
- eccentric external rotators at 60°/s,
- concentric endurance internal rotators at 120°/s,
- concentric endurance external rotators at 120°/s,
Measured: 4 months
Return to same sport at pre-injury level assessed at 12 months post-operatively
questionnaire to the patient : what sport do you practice, which level?
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2028 (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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- one group of volunteers, one group of patients
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602713
- Sponsor's protocol ID
- 2024-A00418-39
- Acronym
- ISO-LAT
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability of Rotator Cuff Muscle Strength Levels, Assessed by Isokinetic Dynamometry, to Predict Return to Sport After Shoulder Stabilization Surgery by Open Latarjet Procedure
- ClinicalTrials.gov ID
- NCT06602713
- Acronym / sponsor ID
- ISO-LAT / 2024-A00418-39
- Conditions
- Latarjet, Shoulder Injuries, Rotator Cuff Injuries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 19 Sep 2024 (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 stabilization surgical treatment by open Latarjet procedure is one of the reference treatments after anterior glenohumeral dislocation in athletes. This surgical technique allows low recurrence rates and high return to sport rates. Indeed, more than 90% of athletes return to sport after this type of surgery, but only 60% are able to resume the same activity as a preinjury level of performance. Therefore, adaptations in the postoperative management of athletes patients seem necessary. Isokinetic dynamometry is considered the gold standard to provide an objective assessment of muscle strength abilities, particularly in the clinical setting. Although rehabilitation exercises are prescribed early after the Latarjet procedure, muscle deconditioning occurs during the postoperative phase, limiting the abilities of the rotator cuff muscles to provide stability to the glenohumeral joint. Therefore, recovery of all components of strength, i.e. maximal strength, power, and strength endurance of the rotator cuff muscles appears crucial for the athletes to return to their sport at the pre-injury level. However, at present, the strength levels to be recovered remain to be defined.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- one group of volunteers, one group of patients
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Active comparator | Other: Questionnaires, Other: ExercicesQuestionnaires and exercices |
| Patient operated at shoulder by open Latarjet procedure | Experimental | Other: Questionnaires, Other: ExercicesQuestionnaires and exercices |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Be aged between 18 and 45
- Occurrence of the injury during the practice of a sporting activity
- Post-traumatic anterior glenohumeral subluxation/dislocation
- Contralateral shoulder with no history of injury
- No other associated shoulder pathology
Key exclusion criteria (9 listed)
- Contraindication from the sports clinician or surgeon
- Have another pathology in the upper limbs.
- Have constitutional hyperlaxity
- Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Declare a history of pain/injury in the upper limbs in the last 6 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 |
|---|---|---|
| QuestionnairesWestern Ontario Shoulder Instability questionnaire Western Ontario Rotator Cuff questionnaire Shoulder Instability Return to Sport after Injury questionnaire | Other | Healthy volunteers, Patient operated at shoulder by open Latarjet procedure |
| Exercicesisokinetic evaluation | Other | Healthy volunteers, Patient operated at shoulder by open Latarjet procedure |
Primary outcome
Bilateral glenohumeral rotator muscle strength differences assessed at 4 months postoperatively
Time frame: 4 months
Bilateral muscle strength gap at 4 months postoperatively: * concentric internal rotators at 60°/s * concentric external rotators at 60°/s, * eccentric internal rotators at 60°/s, * eccentric external rotators at 60°/s, * concentric endurance internal rotators at 120°/s, * concentric endurance external rotators at 120°/s,
Return to same sport at pre-injury level assessed at 12 months post-operatively
Time frame: 12 months
questionnaire to the patient : what sport do you practice, which level?
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires and Exercices 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 16 inclusion and 9 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: opening soon, as of the sponsor's last update on 19 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Rogowski (0033 4 72 43 28 48, isabelle.rogowski@univ-lyon1.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bilateral glenohumeral rotator muscle strength differences assessed at 4 months postoperatively (time frame: 4 months). 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 19 Sep 2024.