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

NCT ID: NCT06602713

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2028-10-01

Brief 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.

Conditions

Latarjet; Shoulder Injuries; Rotator Cuff Injuries

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Healthy volunteers

Questionnaires and exercices

Group Type: ACTIVE_COMPARATOR

Questionnaires

Intervention Type: OTHER

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

Exercices

Intervention Type: OTHER

isokinetic evaluation

Patient operated at shoulder by open Latarjet procedure

Questionnaires and exercices

Group Type: EXPERIMENTAL

Questionnaires

Intervention Type: OTHER

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

Exercices

Intervention Type: OTHER

isokinetic evaluation

Interventions

Questionnaires

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

Intervention Type: OTHER

Exercices

isokinetic evaluation

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: collaborator

Ramsay Générale de Santé

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital privé Jean Mermoz

Lyon, , France

Countries

France

Central Contacts

Isabelle Rogowski

Role: CONTACT

isabelle.rogowski@univ-lyon1.fr

0033 4 72 43 28 48

Facility Contacts

Lionel Neyton, Dr

Role: primary

secretariat.scientifique@orthosanty.fr

04 37 53 00 57

Other Identifiers

2024-A00418-39

Identifier Type: -

Identifier Source: org_study_id