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

NCT06602713 | Not Yet Recruiting

• 1 other identifier: 2024-A00418-39
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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,

  4 months

• 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?

  12 months

Study Arms (2)

Healthy volunteers

ACTIVE COMPARATOR

Questionnaires and exercices

Other: Questionnaires; Other: Exercices

Patient operated at shoulder by open Latarjet procedure

EXPERIMENTAL

Questionnaires and exercices

Other: Questionnaires; Other: Exercices

Interventions

Questionnaires OTHER

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

Healthy volunteers; Patient operated at shoulder by open Latarjet procedure

Exercices OTHER

isokinetic evaluation

Healthy volunteers; Patient operated at shoulder by open Latarjet procedure

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• GCS Ramsay Santé pour l'Enseignement et la Recherche: collaborator

Study Sites (1)

Hopital privé Jean Mermoz

Lyon, 69008, France

Location

MeSH Terms

Conditions

Shoulder Injuries; Rotator Cuff Injuries

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Wounds and Injuries; Rupture; Tendon Injuries

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Isabelle Rogowski

CONTACT

0033 4 72 43 28 48; isabelle.rogowski@univ-lyon1.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: one group of volunteers, one group of patients

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

FR (1)