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

R

Ramsay Générale de Santé

Status

Not yet enrolling

Conditions

Shoulder Injuries
Latarjet
Rotator Cuff Injuries

Treatments

Other: Questionnaires
Other: Exercices

Study type

Interventional

Funder types

Other

Identifiers

NCT06602713
2024-A00418-39

Details and patient eligibility

About

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.

Enrollment

210 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

210 participants in 2 patient groups

Healthy volunteers
Active Comparator group
Description:
Questionnaires and exercices
Treatment:
Other: Exercices
Other: Questionnaires
Patient operated at shoulder by open Latarjet procedure
Experimental group
Description:
Questionnaires and exercices
Treatment:
Other: Exercices
Other: Questionnaires

Trial contacts and locations

1

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Central trial contact

Isabelle Rogowski

Data sourced from clinicaltrials.gov

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