Anterior Cruciate Ligament Reconstruction (Préhab-LCA)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Enrolling

Conditions: Ligament Rupture

Treatments: Procedure: Reconstructive surgery of the anterior cruciate ligament

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06099600

2023-A01633-42

Details and patient eligibility

About

This study evaluates the effectiveness of a pre-habilitation stay via digital monitoring on patients' short-term post-operative anxiety, compared with conventional management.

Full 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).

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

pre-habilitation stays

Experimental group

Description:

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.

Treatment:

Procedure: Reconstructive surgery of the anterior cruciate ligament

conventional care

Active Comparator group

Description:

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.

Treatment:

Procedure: Reconstructive surgery of the anterior cruciate ligament