Back to resultsInfluence of an Anterior Latarjet-type Abutment Operation on Scapular Dyskinesia and the Muscular Stabilization Mechanisms of the Scapula (DyScapLat) (DyScapLat)
Primary Purpose
Latarjet, Scapular Dyskinesis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Latarjet method
Different arms exercices
Sponsored by
About this trial
This is an interventional other trial for Latarjet
Eligibility Criteria
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
Sites / Locations
- Hopital privé Jean MermozRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patient requiring anterior abutment surgery by Latarjet method
Healthy volunteers
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05131126
First Posted
November 10, 2021
Last Updated
November 10, 2021
Sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network
1. Study Identification
Unique Protocol Identification Number
NCT05131126
Brief Title
Influence of an Anterior Latarjet-type Abutment Operation on Scapular Dyskinesia and the Muscular Stabilization Mechanisms of the Scapula (DyScapLat)
Acronym
DyScapLat
Official Title
Influence of an Anterior Latarjet-type Abutment Operation on Scapular Dyskinesia and the Muscular Stabilization Mechanisms of the Scapula (DyScapLat)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2019 (Actual)
Primary Completion Date
October 26, 2021 (Actual)
Study Completion Date
May 22, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Latarjet, Scapular Dyskinesis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient requiring anterior abutment surgery by Latarjet method
Arm Type
Experimental
Arm Title
Healthy volunteers
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Latarjet method
Intervention Description
This operation consists of fixing a bone graft
Intervention Type
Other
Intervention Name(s)
Different arms exercices
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in position of the scapula (tilt, rotation and bell) between the pre and post-test measured in the control group
Description
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.
Time Frame
4 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-François Oudet
Phone
0683346567
Email
jf.oudet@ecten.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Hélène Barba
Email
mh.barba@ecten.eu
Facility Information:
Facility Name
Hopital privé Jean Mermoz
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel Neyton, Dr
Phone
04 37 53 00 57
Email
neyton.lionel@orange.fr
12. IPD Sharing Statement
Learn more about this trial
Influence of an Anterior Latarjet-type Abutment Operation on Scapular Dyskinesia and the Muscular Stabilization Mechanisms of the Scapula (DyScapLat)
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