Anterior Cruciate Ligament Reconstruction

Not Applicable

Not yet recruiting

• Conditions: Ligament Rupture
• Interventions: Procedure: Reconstructive surgery of the anterior cruciate ligament

• Registration Number: NCT06099600
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

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 and scheduled anterior cruciate ligament surgical reconstruction. Patients will be randomized into 2 arms, an experimental arm A (pre-habilitation management) and a control arm B (conventional management).

Study Timeline

• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-10-19
• Study First Posted: 2023-10-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Study Start: 2025-04
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• 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 Criteria

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional care	Reconstructive surgery of the anterior cruciate ligament	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.
pre-habilitation stays	Reconstructive surgery of the anterior cruciate ligament	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.

Primary Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory questionnaire	7 days	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)

Trial Locations

Locations (1)

Clinique de la Sauvegarde; 🇫🇷 Lyon, France