Influence of an Anterior Latarjet-type Abutment Operation on Scapular Dyskinesia and the Muscular Stabilization Mechanisms of the Scapula (DyScapLat) (DyScapLat)

The aim of this study is to assess the influence of anterior abutment surgery using the Latarjet method on the kinematics of the scapula. The sub-objectives will be to show that Latarjet-type surgery does not lead to scapular dyskinesia and modification of muscle activity compared to a control group that has not undergone an operation.

Study Overview

• Status: Recruiting
• Conditions: Latarjet; Scapular Dyskinesis
• Intervention / Treatment: Procedure: Latarjet method; Other: Different arms exercices

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69008
    • Recruiting
    • Hopital Prive Jean Mermoz
    • Contact: Lionel Neyton, Dr; Phone Number: 04 37 53 00 57; Email: neyton.lionel@orange.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Patient Group:

  • Male between 18 and 40 years-old
  • Practice a regular sports activity before the injury (s) requiring surgery
  • Present the clinical criteria leading to anterior abutment surgery using the Latarjet method
  • Surgery performed by surgeons from the Jean-Mermoz Private Hospital (69008 Lyon)
  • Have followed a post-surgery self-rehabilitation program

Control group:

• Male between 18 and 40 years-old
• Practice a regular sports activity

Both group:

oPatient having signed an informed consent o Subject affiliated or beneficiary of a social security scheme

Exclusion Criteria:

Patient group:

• Have another shoulder pathology on the side of the operated limb or on the contralateral side
• Present a constitutional hyper laxity
• Have stiffness or recurrence of dislocation of the shoulder post-surgery
• Have a body mass index greater than 30 kg / m² (to ensure sufficient accuracy to measure the movements of the scapula)
• Wear a pacemaker or any other metal device (e.g. patch with metal material)
• Present a contraindication to the use of measuring devices (intolerance to a weak electromagnetic field)

Control group:

• Present during the study or have presented in the past any musculoskeletal pathology in the right or left shoulder (WOSI or WORC score greater than 250).
• Have a body mass index greater than 30 kg / m² (to ensure sufficient accuracy to measure the movements of the scapula)
• Wear a pacemaker or any other metal device (e.g. patch with metal material)
• Present a contraindication to the use of measuring devices (intolerance to a weak electromagnetic field)

Both group :

o 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: Other
• 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	Other: Different arms exercices; Perform 5 elevation movements in each of the elevation planes (sagittal, scapular and coronal) with the right and left arms; Perform 5 circumduction movements with the right and left arms; Maintain a weight of 1kg twice for 5 seconds with the arms at 90 ° of elevation.
Experimental: Patient requiring anterior abutment surgery by Latarjet method	Procedure: Latarjet method; This operation consists of fixing a bone graft; Other: Different arms exercices; Perform 5 elevation movements in each of the elevation planes (sagittal, scapular and coronal) with the right and left arms; Perform 5 circumduction movements with the right and left arms; Maintain a weight of 1kg twice for 5 seconds with the arms at 90 ° of elevation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in position of the scapula (tilt, rotation and bell) between the pre and post-test measured in the control group	For electromyographic analysis, the signals will be filtered, smoothed and normalized to obtain a percentage of activation relative to that measured during submaximal voluntary contractions.	4 months

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: European Clinical Trial Experts Network

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2019
• Primary Completion (Actual): October 26, 2021
• Study Completion (Anticipated): May 22, 2023

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 10, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias
• Other Study ID Numbers: 2018-A02449-46

Drug and device information, study documents

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