Menu
Not yet recruiting NCT06602713

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

No phase Interventional Latarjet Shoulder Injuries Rotator Cuff Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaires, Exercices.
Who it may be relevant to
Registry conditions: Latarjet, Shoulder Injuries, Rotator Cuff Injuries. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Questionnaires
    Western Ontario Shoulder Instability questionnaire Western Ontario Rotator Cuff questionnaire Shoulder Instability Return to Sport after Injury questionnaire
  • Other Exercices
    isokinetic evaluation

Primary outcome measures

  • Bilateral glenohumeral rotator muscle strength differences assessed at 4 months postoperatively [Time frame: 4 months]
  • Return to same sport at pre-injury level assessed at 12 months post-operatively [Time frame: 12 months]

Eligibility criteria

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 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

Exclusion criteria

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):

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • Hopital privé Jean Mermoz — Lyon

Identifiers

NCT: NCT06602713 · 2024-A00418-39

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗