Préhab-LCA: Randomized Study of Anterior Cruciate Ligament Reconstruction
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Anxiety-state total score [1 year]
State-Trait Anxiety Inventory total score versus baseline score (before surgery and before the pre-habilitation stay for patients in the experimental group)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age > 18 ;
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Partial or complete primary anterior cruciate ligament rupture;
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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;
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Willingness to complete questionnaires at regular intervals;
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Membership of a social security scheme;
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Signed informed consent.
Exclusion Criteria:
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Recurrence / contralateral lesion ;
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Stage III collateral ligament injury;-
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Osteotomy ;
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Neurological (motor and/or sensory), vestibular or rheumatic pathology;
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Pregnant or breast-feeding woman;
-
Protected adult patient (under guardianship, curatorship or deprivation of liberty).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinique de la Sauvegarde | Lyon | France | 69009 |
Sponsors and Collaborators
- GCS Ramsay Santé pour l'Enseignement et la Recherche
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-A01633-42