Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-10 @ 7:39 AM
Study NCT ID:
NCT02474004
Status:
UNKNOWN
Last Update Posted:
2016-07-19
First Post:
2015-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gait Analysis Meniscal Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'lastUpdateSubmitDate': '2016-07-16', 'studyFirstSubmitDate': '2015-06-04', 'studyFirstSubmitQcDate': '2015-06-12', 'lastUpdatePostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'KOOS', 'timeFrame': '6 months post', 'description': 'knee specific patient-reported outcome measurement'}], 'primaryOutcomes': [{'measure': 'knee adduction moment [Nm/kg]', 'timeFrame': 'once after 6 months', 'description': 'a parameter of gait analysis'}], 'secondaryOutcomes': [{'measure': 'set of kinetic, kinematic and temporospatial gait parameters', 'timeFrame': 'once after 6 months', 'description': 'other gait parameters'}]}, 'conditionsModule': {'conditions': ['Lesion of the Medial Meniscus']}, 'descriptionModule': {'briefSummary': 'In the past it was shown, that medial partial meniscectomy (MPM) leads to an increase of the knee adduction moment (KAM) during walking. Other researches found out that an increase of the KAM is an important factor contributing to degeneration joint disease of the knee (osteoarthritis). Today, medial menicus repair (MMR) is favoured by many knee surgeons, because preserving as much of the meniscus as possible is assumed to delay degenerative joint disease.\n\nThe investigators hypothesize significant differences in knee adduction moments between patients treated with partial medial meniscectomy vs. patients treated with medial meniscus repair (hypothesis 1; major hypothesis). Additionally, it is hypothesized that: the mentioned groups differ with respect to other kinetic and kinematic key parameters of gait (hypothesis 2) and that the knee adduction moment correlates with the clinical outcome as determined by a typical knee score (hypothesis 3).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: patients with traumatic medial meniscus lesions scheduled for meniscal repair or resection\n\nExclusion Criteria:\n\n* previous or current diseases of the back and the other joints of the lower limbs\n* any form of inflammatory arthritis\n* diabetes\n* neurological disorders\n* other conditions that may affect gait'}, 'identificationModule': {'nctId': 'NCT02474004', 'briefTitle': 'Gait Analysis Meniscal Repair', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': '3D-gait Analysis in Patients With Medial Meniscus Repair vs. Partial Meniscectomy', 'orgStudyIdInfo': {'id': 'GAIT-Men1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'medial meniscus repair', 'description': 'patients receiving medial meniscus repair', 'interventionNames': ['Procedure: medial meniscal surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'medial partial meniscectomy', 'description': 'patients having medial partial meniscectomy', 'interventionNames': ['Procedure: medial meniscal surgery']}], 'interventions': [{'name': 'medial meniscal surgery', 'type': 'PROCEDURE', 'description': 'one group/arm has meniscal repair as part of clinical routine one group/arm has meniscal partial resection as part of clinical routine both groups have gait analysis \\& knee scores 6 mo after the procedures', 'armGroupLabels': ['medial meniscus repair', 'medial partial meniscectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Michael C Liebensteiner, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Innsbruck Medical University, Dept. Orthop. Surgery', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Christian Fink, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sportsclinic Austria', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'centralContacts': [{'name': 'Michael C Liebensteiner, MD, PhD', 'role': 'CONTACT', 'email': 'michael.liebensteiner@i-med.ac.at', 'phone': '+43 512 504 80547'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michael Liebensteiner', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Michael Liebensteiner', 'investigatorAffiliation': 'Medical University Innsbruck'}}}}