Anterior Cruciate Ligament Reconstruction

NCT ID: NCT06099600

Last Updated: 2025-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-26

Study Completion Date

2027-12-31

Brief Summary

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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

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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).

Conditions

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Ligament Rupture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Reconstructive surgery of the anterior cruciate ligament

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Reconstructive surgery of the anterior cruciate ligament

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Euraxi Pharma

INDUSTRY

Sponsor Role collaborator

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique de la Sauvegarde

Lyon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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David DEJOUR, MD

Role: CONTACT

472200000 ext. +33

Facility Contacts

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David DEJOUR, MD

Role: primary

Other Identifiers

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2023-A01633-42

Identifier Type: -

Identifier Source: org_study_id

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