Randomized Study of Anterior Cruciate Ligament Reconstruction

Study Overview
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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).

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

Conditions
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Ligament Rupture

Intervention / Treatment
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* Procedure: Reconstructive surgery of the anterior cruciate ligament


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pre-habilitation stays<br>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<br>* 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<br>|
| Active Comparator: conventional care<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety-state total score | State-Trait Anxiety Inventory total score versus baseline score (before surgery and before the pre-habilitation stay for patients in the experimental group) | 1 year |