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Randomized Study of Anterior Cruciate Ligament Reconstruction (Préhab-LCA)

Primary Purpose

Ligament Rupture

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Reconstructive surgery of the anterior cruciate ligament
Sponsored by
GCS Ramsay Santé pour l'Enseignement et la Recherche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ligament Rupture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Clinique de la Sauvegarde

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

pre-habilitation stays

conventional care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
October 19, 2023
Last Updated
October 19, 2023
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
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1. Study Identification

Unique Protocol Identification Number
NCT06099600
Brief Title
Randomized Study of Anterior Cruciate Ligament Reconstruction
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ligament Rupture

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pre-habilitation stays
Arm Type
Experimental
Arm Description
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.
Arm Title
conventional care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Reconstructive surgery of the anterior cruciate ligament
Intervention Description
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
Primary Outcome Measure Information:
Title
Anxiety-state total score
Description
State-Trait Anxiety Inventory total score versus baseline score (before surgery and before the pre-habilitation stay for patients in the experimental group)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David DEJOUR, MD
Phone
472200000
Ext
+33
Email
dejour.secretariat@lyon-ortho-clinic.com
Facility Information:
Facility Name
Clinique de la Sauvegarde
City
Lyon
ZIP/Postal Code
69009
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David DEJOUR, MD
Email
dejour.secretariat@lyon-ortho-clinic.com

12. IPD Sharing Statement

Learn more about this trial

Randomized Study of Anterior Cruciate Ligament Reconstruction

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