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NCT Number: 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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

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

Exercices

Other

isokinetic evaluation

Primary outcomes

  1. 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,
  2. 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?

Study contacts

Contact information is provided by the study sponsor or research team.

Isabelle Rogowski

CONTACT

[email protected]

0033 4 72 43 28 48

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: ISO-LAT

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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