Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-29 @ 6:54 PM
Study NCT ID:
NCT06099600
Status:
RECRUITING
Last Update Posted:
2025-07-01
First Post:
2023-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anterior Cruciate Ligament Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2023-10-19', 'studyFirstSubmitQcDate': '2023-10-19', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'State-Trait Anxiety Inventory questionnaire', 'timeFrame': '7 days', 'description': '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)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ligament Rupture']}, 'descriptionModule': {'briefSummary': "This study evaluates the effectiveness of a pre-habilitation stay via digital monitoring on patients' short-term post-operative anxiety, compared with conventional management.", 'detailedDescription': 'This is a prospective, comparative, randomized (2-arm), controlled, single-center study of two management modalities.\n\nRecruitment 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 ;\n* Partial or complete primary anterior cruciate ligament rupture;\n* Partial or complete primary rupture of the anterior cruciate ligament;\n* Scheduled anterior cruciate ligament reconstructive surgery;\n* Patient with a tablet, computer or smartphone with an internet connection;\n* Patient able to understand and read French;\n* Willingness to complete questionnaires at regular intervals;\n* Membership of a social security scheme;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Recurrence / contralateral lesion ;\n* Stage III collateral ligament injury;-\n* Osteotomy ;\n* Neurological (motor and/or sensory), vestibular or rheumatic pathology;\n* Pregnant or breast-feeding woman;\n* Protected adult patient (under guardianship, curatorship or deprivation of liberty).'}, 'identificationModule': {'nctId': 'NCT06099600', 'acronym': 'Préhab-LCA', 'briefTitle': 'Anterior Cruciate Ligament Reconstruction', 'organization': {'class': 'OTHER', 'fullName': "GCS Ramsay Santé pour l'Enseignement et la Recherche"}, 'officialTitle': 'Randomized Study Evaluating the Value of a Pre-habilitation Stay and Digital Follow-up, Compared With Standard Management, in Anterior Cruciate Ligament Reconstruction', 'orgStudyIdInfo': {'id': '2023-A01633-42'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pre-habilitation stays', '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.', 'interventionNames': ['Procedure: Reconstructive surgery of the anterior cruciate ligament']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional care', '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.', 'interventionNames': ['Procedure: Reconstructive surgery of the anterior cruciate ligament']}], 'interventions': [{'name': 'Reconstructive surgery of the anterior cruciate ligament', 'type': 'PROCEDURE', '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', 'armGroupLabels': ['conventional care', 'pre-habilitation stays']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69009', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'David DEJOUR, MD', 'role': 'CONTACT', 'email': 'dejour.secretariat@lyon-ortho-clinic.com'}], 'facility': 'Clinique de la Sauvegarde', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'David DEJOUR, MD', 'role': 'CONTACT', 'email': 'dejour.secretariat@lyon-ortho-clinic.com', 'phone': '472200000', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "GCS Ramsay Santé pour l'Enseignement et la Recherche", 'class': 'OTHER'}, 'collaborators': [{'name': 'Euraxi Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}