Anterior Cruciate Ligament Reconstruction (Préhab-LCA)

Randomized Study Evaluating the Value of a Pre-habilitation Stay and Digital Follow-up, Compared With Standard Management, in Anterior Cruciate Ligament Reconstruction

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

Study Overview

• Status: Recruiting
• Conditions: Ligament Rupture
• Intervention / Treatment: Procedure: Reconstructive surgery of the anterior cruciate ligament

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 Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David DEJOUR, MD; Phone Number: +33 472200000; Email: dejour.secretariat@lyon-ortho-clinic.com

Study Locations

• France
  • Lyon, France, 69009
    • Recruiting
    • Clinique de la Sauvegarde
    • Contact: David DEJOUR, MD; Email: dejour.secretariat@lyon-ortho-clinic.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pre-habilitation stays; 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; 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
Active Comparator: conventional care; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Collaborators: Euraxi Pharma

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 26, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: 2023-A01633-42

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No