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

Scapular Dyskinesis Clinical Trial

— DyScapLat  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05131126
• Other study ID #: 2018-A02449-46
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2019
• Est. completion date: May 22, 2023

Study information

• Verified date: November 2021
• Source: Ramsay Générale de Santé
• Contact: Jean-François Oudet
• Phone: 0683346567
• Email: jf.oudet[@]ecten.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 22, 2023
• Est. primary completion date: October 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyskinesias
• Scapular Dyskinesis

Intervention

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.

Locations

Country	Name	City	State
France	Hopital privé Jean Mermoz	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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