Anterior Cruciate Ligament Reconstruction

Ligament Rupture Clinical Trial

— Préhab-LCA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06099600
• Other study ID #: 2023-A01633-42
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: March 2026

Study information

• Verified date: April 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: David DEJOUR, MD
• Phone: 472200000
• Email: dejour.secretariat[@]lyon-ortho-clinic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Ligament Rupture
• Rupture

Intervention

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

Locations

Country	Name	City	State
France	Clinique de la Sauvegarde	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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