Anterior Cruciate Ligament Reconstruction

NCT06099600 | Recruiting

• 1 other identifier: 2023-A01633-42
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Ligament Rupture

Outcome Measures

Primary Outcomes (1)

• State-Trait Anxiety Inventory questionnaire

  The main evaluation criterion is the total "state-anxiety" score of the State-Trait Anxiety Inventory questionnaire on 7 days compared to the score measured at least 25 days (i.e. baseline value: before the surgical intervention and before the pre-habilitation stay taking place for patients in the experimental group)

  7 days

Study Arms (2)

pre-habilitation stays

EXPERIMENTAL

Pre-habilitation involves taking part in a half-day information session led by a physiotherapist and a nurse prior to surgery. Patients will benefit from digital monitoring via the Orthense application, as well as scheduled surgery (anterior cruciate ligament reconstruction) and the usual peri-operative medical follow-up.

Procedure: Reconstructive surgery of the anterior cruciate ligament

conventional care

ACTIVE COMPARATOR

During their pre-operative visit with the surgeon, patients will receive a booklet containing information on the peri-operative period, possible complications, how to prevent them and what to do should they occur. Patients will benefit from standard computerized follow-up, as well as the scheduled surgical procedure (anterior cruciate ligament reconstruction) and the usual peri-operative medical follow-up.

Procedure: Reconstructive surgery of the anterior cruciate ligament

Interventions

Reconstructive surgery of the anterior cruciate ligament PROCEDURE

surgical reconstruction after rupture of the anterior cruciate ligament is widely proposed as first-line treatment, with the aim of restoring knee joint stability and facilitating functional recovery

conventional care; pre-habilitation stays

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Euraxi Pharma: collaborator

Study Sites (1)

Clinique de la Sauvegarde

Lyon, 69009, France

RECRUITING

Central Study Contacts

David DEJOUR, MD

CONTACT

472200000; dejour.secretariat@lyon-ortho-clinic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 25, 2023
• Study Start: June 26, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

FR (1)