Value of Capsular Repair for Latarjet
ConditionShoulder Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche
About this trial
The purpose of the study is to evaluate the occurrence of osteoarthritis (YES/NO) by radiography.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient, male or female, over the age of 18
Patient with shoulder instability with risk factors for recurrence (ISIS score > 3), requiring surgical stabilization by abutment
Affiliated patient or beneficiary of a social security scheme
Patient having been informed and having given his free, informed and written consent.
Disqualifiers
Patient with history of surgery for instability of the same shoulder
Patient presenting contraindications to the realization of a postoperative scanner
Patient whose physical and/or psychological health is severely impaired, which according to the investigator may affect the compliance of the study participant
Patient participating in another clinical research or in a period of exclusion from another research still in progress at the time of inclusion
Trial design
Design model
Parallel
Treatments tested in this trial
Latarjet technique
Procedure/SurgeryRealization of a stop according to Latarjet
Treatment groups
86 Participants
are divided into 2 treatment groupsGroup A: With capsular repairExperimental treatment 1 intervention
Group B: Without capsular repairActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
occurrence of osteoarthritis
Change from occurrence of osteoarthritis (YES/NO) on X-ray at 5 and 10 years, compared to inclusion X-ray using the Samilson-Prieto classification.
Time frame
10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead sponsor
Euraxi Pharma
Collaborator
Source ClinicalTrials.gov