Anterior Cruciate Ligament Reconstruction

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06099600

Acronym

Préhab-LCA

Enrollment

Registered

2023-10-25

Start date

2025-06-26

Completion date

2027-12-31

Last updated

2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ligament Rupture

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).

Interventions

PROCEDUREReconstructive 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age\>18; * Partial or complete tear 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

* History of anterior cruciate ligament surgery within the past 5 years; * 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).

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

France

Contacts

CONTACTDavid DEJOUR, MD

dejour.secretariat@lyon-ortho-clinic.com472200000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026