ClinicalTrials.gg
Not yet recruitingNCT06602713ISO-LATUpdated Sep 19, 2024

Ability of Rotator Cuff Muscle Strength Levels, Assessed by Isokinetic Dynamometry, to Predict Return to Sport After Shoulder Stabilization Surgery by Open Latarjet Procedure

An interventional study of Questionnaires and Exercices in Latarjet, Shoulder Injuries and Rotator Cuff Injuries, sponsored by Ramsay Générale de Santé. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Primary conditionRotator Cuff InjuriesRegistry: Shoulder InjuriesReclassifiedWhy we changed it
Registry
Shoulder Injuries — the first condition term the registry derived for this study.
ClinicalTrials.gg
Rotator Cuff Injuries
Why
  1. The study's listed conditions name Rotator Cuff Injuries, a narrower term within Shoulder Injuries.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Ramsay Générale de Santé · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
210
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Latarjet
  • Shoulder Injuries
  • Rotator Cuff Injuries

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03

In context

Rotator Cuff Injuries Reclassified

631 studies on the registry are indexed under Rotator Cuff Injuries; 156 are open to participants now.

This study's planned enrollment of 210 is above the median of 60 across 456 interventional studies indexed under Rotator Cuff Injuries.

Browse Rotator Cuff Injuries studies →

Lead sponsor

Ramsay Générale de Santé is the lead sponsor of 42 studies on the registry; 10 are open to participants now.

Compared within Rotator Cuff Injuries, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Shoulder Injuries. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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
  • Patient scheduled for shoulder stabilizing surgery using an open Latarjet procedure performed by one of the surgeons at the Santy Orthopedic Center (Lyon)
  • No to isokinetic assessment
  • Patient having signed
  • 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

Exclusion criteria

Exclusion Criteria:

Patient group:

  • 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):

  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
210 participants (estimated)

Study arms

  • Active comparator
    Healthy volunteers

    Questionnaires and exercices

    Other: Questionnaires · Other: Exercices

  • Experimental
    Patient operated at shoulder by open Latarjet procedure

    Questionnaires and exercices

    Other: Questionnaires · Other: Exercices

Interventions

  • OtherQuestionnaires

    Western Ontario Shoulder Instability questionnaire Western Ontario Rotator Cuff questionnaire Shoulder Instability Return to Sport after Injury questionnaire

  • OtherExercices

    isokinetic evaluation

06

What researchers measure

Primary outcomes

  1. 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,

    Time frame: 4 months

  2. 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?

    Time frame: 12 months

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06602713
Lead sponsor
Ramsay Générale de Santé
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Oct 1, 2024 (estimated)
Primary completion
Oct 1, 2026 (estimated)
Completion
Oct 1, 2028 (estimated)
Last update
Sep 19, 2024

Study contacts

Isabelle Rogowski
Contact
isabelle.rogowski@univ-lyon1.fr
0033 4 72 43 28 48

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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