Status:
RECRUITING
Anterior Cruciate Ligament Reconstruction
Lead Sponsor:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Collaborating Sponsors:
Euraxi Pharma
Conditions:
Ligament Rupture
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study evaluates the effectiveness of a pre-habilitation stay via digital monitoring on patients' short-term post-operative anxiety, compared with conventional management.
Detailed Description
This is a prospective, comparative, randomized (2-arm), controlled, single-center study of two management modalities. Recruitment will focus on adult patients with anterior cruciate ligament rupture ...
Eligibility Criteria
Inclusion
- Age \> 18 ;
- Partial or complete primary anterior cruciate ligament rupture;
- Partial or complete primary rupture of the anterior cruciate ligament;
- Scheduled anterior cruciate ligament reconstructive surgery;
- Patient with a tablet, computer or smartphone with an internet connection;
- Patient able to understand and read French;
- Willingness to complete questionnaires at regular intervals;
- Membership of a social security scheme;
- Signed informed consent.
Exclusion
- Recurrence / contralateral lesion ;
- Stage III collateral ligament injury;-
- Osteotomy ;
- Neurological (motor and/or sensory), vestibular or rheumatic pathology;
- Pregnant or breast-feeding woman;
- Protected adult patient (under guardianship, curatorship or deprivation of liberty).
Key Trial Info
Start Date :
June 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06099600
Start Date
June 26 2025
End Date
December 1 2027
Last Update
July 1 2025
Active Locations (1)
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1
Clinique de la Sauvegarde
Lyon, France, 69009