NCT05131126

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2021

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2023

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

2.4 years

First QC Date

November 10, 2021

Last Update Submit

November 10, 2021

Conditions

LatarjetScapular Dyskinesis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Patient requiring anterior abutment surgery by Latarjet method

EXPERIMENTAL
Procedure: Latarjet methodOther: Different arms exercices

Healthy volunteers

ACTIVE COMPARATOR
Other: Different arms exercices

Interventions

Latarjet methodPROCEDURE

This operation consists of fixing a bone graft

Patient requiring anterior abutment surgery by Latarjet method
Different arms exercicesOTHER

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.

Healthy volunteersPatient requiring anterior abutment surgery by Latarjet method

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital privé Jean Mermoz

Lyon, 69008, France

RECRUITING

Central Study Contacts

Jean-François Oudet

CONTACT

0683346567jf.oudet@ecten.eu

Marie-Hélène Barba

CONTACT

mh.barba@ecten.eu

Study Design

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

Study Record Dates

First Submitted

November 10, 2021

First Posted

November 23, 2021

Study Start

May 22, 2019

Primary Completion

October 26, 2021

Study Completion

May 22, 2023

Last Updated

November 23, 2021

Record last verified: 2021-11

Locations

FR(1)