Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
Study NCT ID:
NCT02425995
Status:
COMPLETED
Last Update Posted:
2016-10-04
First Post:
2015-04-15
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interest of Additional Arthroscopic Portals in Diagnosis of Hidden Lesions of the Medial Meniscus in Pediatrics Knees With ACL Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-03', 'studyFirstSubmitDate': '2015-04-15', 'studyFirstSubmitQcDate': '2015-04-21', 'lastUpdatePostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of hidden lesions diagnosed in Arthroscopic Posteromedial Portal and not seen in classic arthroscopic portals and Intercondylar Portal.', 'timeFrame': 'Day 1 (during surgery)', 'description': 'Diagnosis of a hidden lesion of the Posterior Horn of the Medial Meniscus in Arthroscopic Posteromedial Portal, which has not be seen in classic arthroscopic portals and Intercondylar Portal.'}], 'secondaryOutcomes': [{'measure': 'Number of hidden lesions diagnosed during the arthroscopic procedure and not seen in preoperatively MRI.', 'timeFrame': 'Day 1 (during surgery)', 'description': 'Diagnosis of a hidden lesion of the posterior horn of the medial meniscus during the arthroscopic procedure, lesion not seen in preoperatively MRI.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ACL', 'Hidden lesions of the medial meniscus', 'Chronic knee instability', 'Intercondylar and posteromedial arthroscopy', 'Arthroscopic Posteromedial and Intercondylar portal', 'Diagnosis capacity of hidden lesions of the medial meniscus'], 'conditions': ['Chronic Knee Instability']}, 'descriptionModule': {'briefSummary': 'Peroperatively observative study in pediatric orthopedic center in Lyon, France.\n\n50 pediatric patients included in this study, to improve the diagnosis of hidden lesions of the medial meniscus associated with lesions of the anterior cruciate ligament.\n\nAll the patients need a reconstruction of the ACL because of chronic knee instability.\n\nAll the patients underwent a multi portal arthroscopy during the ACL reconstruction : anteromedial and anterolateral and after intercondylar and posteromedial.\n\nThe study consists in a peroperatively arthroscopic look, in order to diagnose lesions of the posterior horn of the medial meniscus which could be missed in MRI and anteromedial and anterolateral arthroscopy.\n\nStatistics of this lesions are used to study prevalence and diagnosis capacity of this procedures.\n\nFirst, the surgeon did a classic knee arthroscopy. Secondarily, he did an intercondylar portal and after a posteromedial portal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Chronic knee instability with indicated surgery reconstruction\n\nExclusion Criteria:\n\n* Pregnancy\n* No preoperatively knee MRI\n* Posteromedial or Intercondylar Portal Failure\n* Social security system membership failure\n* Refusal of consent of child or parents'}, 'identificationModule': {'nctId': 'NCT02425995', 'briefTitle': 'Interest of Additional Arthroscopic Portals in Diagnosis of Hidden Lesions of the Medial Meniscus in Pediatrics Knees With ACL Deficiency', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Prevalence and Diagnosis of Hidden Lesions of the Posterior Horn of the Medial Meniscus in Pediatric Anterior Cruciate Ligament (ACL) Lesions : Interest of Arthroscopic Intercondylar and Posteromedial Portals', 'orgStudyIdInfo': {'id': '69HCL14_0358'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arthroscopic intercondylar and posteromedial portal', 'interventionNames': ['Procedure: Arthroscopic intercondylar and posteromedial portal']}], 'interventions': [{'name': 'Arthroscopic intercondylar and posteromedial portal', 'type': 'PROCEDURE', 'description': 'Diagnosis of lesions of the Posterior Horn of the Medial Meniscus in Arthroscopic intercondylar and posteromedial portal in addition with standard ACL reconstruction, during the same surgery.', 'armGroupLabels': ['Arthroscopic intercondylar and posteromedial portal']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Franck CHOTEL, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Chirurgie Orthopédique Pédiatrique - Hôpital Femme Mère Enfant - 59, Bd Pinel 69677 BRON CEDEX'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}