Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-29 @ 3:15 AM
Study NCT ID:
NCT01391650
Status:
COMPLETED
Last Update Posted:
2012-05-23
First Post:
2011-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stability of the Knee Joint After Single and Double Bundle Anterior Cruciate Ligament Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-22', 'studyFirstSubmitDate': '2011-05-20', 'studyFirstSubmitQcDate': '2011-07-11', 'lastUpdatePostDateStruct': {'date': '2012-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measurement of rotational and anterior-posterior movement tibia to femur before the replacement of ACL', 'timeFrame': 'one hour', 'description': 'measurement of rotational and anterior-posterior movement tibia to femur before the replacement the ACL (single bundle)or after the tonisation of one portion of ACL in double bundle type of reconstruction of ACL in the operating sale'}], 'secondaryOutcomes': [{'measure': 'measurement of rotational and anterior-posterior movement tibia to femur after the replacement of ACL', 'timeFrame': 'one hour', 'description': 'measurement of rotational and anterior-posterior movement tibia to femur after the replacement the ACL (single bundle)or after the tonisation of second portion of ACL in double bundle type of reconstruction of ACL in the operating sale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ACL', 'double-bundle', 'navigation system'], 'conditions': ['Rupture of Anterior Cruciate Ligament']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://nemzn.cz', 'label': 'web page of investigator affiliation'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective study is to evaluate the influence of both bundles on the knee stability - anterior-posterior translation, internal and external rotations after the double-bundle reconstruction of Anterior Cruciate Ligament and to compare the stability after single-bundle and double-bundle reconstruction using a computer navigation system.', 'detailedDescription': 'The purpose of this prospective study is to evaluate the influence of both bundles on the knee stability - anterior-posterior translation, internal and external rotations after the double-bundle reconstruction of Anterior Cruciate Ligament (ACL) and to compare the stability after single-bundle and double-bundle reconstruction using a computer navigation system.\n\nMethods Anterior-posterior translation, internal rotation, and external rotation were recorded in the deficient condition (without ACL), in the anteromedial-reconstructed, posterolateral-reconstructed, and in the whole ACL-reconstructed condition for double-bundle reconstructions and before and after the ACL reconstruction in single-bundle group. KT-1000 was used to evaluate anterior-posterior translation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '53 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* isolated ACL lesion and primary ACL replacement\n\nExclusion Criteria:\n\n* replacement of ACL with navigation system'}, 'identificationModule': {'nctId': 'NCT01391650', 'briefTitle': 'Stability of the Knee Joint After Single and Double Bundle Anterior Cruciate Ligament Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Znojmo'}, 'officialTitle': 'Rotational and Anteroposterior Stability of the Knee Joint After Single- and Double- Bundle ACL Reconstruction', 'orgStudyIdInfo': {'id': 'DBVSB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'biomechanic of the knee', 'interventionNames': ["Procedure: 'biomechanic of the knee'"]}], 'interventions': [{'name': "'biomechanic of the knee'", 'type': 'PROCEDURE', 'otherNames': ['replacement of ACL'], 'description': '20 patients had their ACL replaced by SB reconstruction from hamstrings, 20 patients double - bundle technique with AM bundle being reconstructed first, and 20 patients with the PL bundle first.', 'armGroupLabels': ['biomechanic of the knee']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66902', 'city': 'Znojmo', 'state': 'Czech Republic', 'country': 'Czechia', 'facility': 'Hospital Znojmo', 'geoPoint': {'lat': 48.8555, 'lon': 16.0488}}], 'overallOfficials': [{'name': 'Martin Komzák', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Znojmo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Znojmo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Masaryk University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'proncipal investigator', 'investigatorFullName': 'Komzak Martin, M.D.', 'investigatorAffiliation': 'Hospital Znojmo'}}}}