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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rotator Cuff Injuries; Shoulder Injuries; Latarjet
• Intervention / Treatment: Other: Questionnaires; Other: Exercices

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabelle Rogowski; Phone Number: 0033 4 72 43 28 48; Email: isabelle.rogowski@univ-lyon1.fr

Study Locations

• France
  • Lyon, France, 69008
    • Hopital Prive Jean Mermoz
    • Contact: Lionel Neyton, Dr; Phone Number: 04 37 53 00 57; Email: secretariat.scientifique@orthosanty.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy volunteers; Questionnaires and exercices	Other: Questionnaires; Western Ontario Shoulder Instability questionnaire Western Ontario Rotator Cuff questionnaire Shoulder Instability Return to Sport after Injury questionnaire; Other: Exercices; isokinetic evaluation
Experimental: Patient operated at shoulder by open Latarjet procedure; Questionnaires and exercices	Other: Questionnaires; Western Ontario Shoulder Instability questionnaire Western Ontario Rotator Cuff questionnaire Shoulder Instability Return to Sport after Injury questionnaire; Other: Exercices; isokinetic evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Rupture; Tendon Injuries; Rotator Cuff Injuries; Wounds and Injuries; Shoulder Injuries
• Other Study ID Numbers: 2024-A00418-39

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No