Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-20 @ 12:43 PM
Study NCT ID:
NCT03044457
Status:
UNKNOWN
Last Update Posted:
2017-02-08
First Post:
2017-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Forgotten Joint Score After Reversed Gap Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'neither the participant nor the outcome assessor know the group. The surgeon of course knows.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups: "reversed gap technique" vs. "gap technique", randomized'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-06', 'studyFirstSubmitDate': '2017-02-03', 'studyFirstSubmitQcDate': '2017-02-03', 'lastUpdatePostDateStruct': {'date': '2017-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forgotten Joint Score 12', 'timeFrame': 'one year after operation', 'description': 'clinical score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Total Knee Arthroplasty', 'Clinical Outcome']}, 'descriptionModule': {'briefSummary': 'A new operation technique was established ("reversed gap technique" for implantation of total knee arthroplasties. Based on the encouraging results of a pilot study, the clinical outcome shall be evaluated using the conventional "gap technique" as control in a RCT study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* indication for implantation a total knee arthroplasty\n\nExclusion Criteria:\n\n* indication for a constrained implant\n* secondary type of arthritis (rheumatoid, post traumatic, post infectious)\n* former "open" surgery on the joint using an arthrotomy or HTO (arthroscopy excluded)'}, 'identificationModule': {'nctId': 'NCT03044457', 'briefTitle': 'Forgotten Joint Score After Reversed Gap Technique', 'organization': {'class': 'OTHER', 'fullName': 'University of Jena'}, 'officialTitle': 'Forgotten Joint Score After Reversed Gap Technique vs. Gap Technique', 'orgStudyIdInfo': {'id': 'TCAFJS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TKA by reversed gap technique', 'description': 'new operative technique of positioning the femoral and tibial component based on soft tissue tension and femoral 3D geometry.', 'interventionNames': ['Procedure: TKA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TKA by gap technique', 'description': 'standard operative technique serving as control. tibia component positioning according to the mechanical axis, femoral component positioning according to the mechanical axis and soft tissue tension in flexion', 'interventionNames': ['Procedure: TKA']}], 'interventions': [{'name': 'TKA', 'type': 'PROCEDURE', 'description': 'femoral and tibial positioning using the "reversed gap technique"', 'armGroupLabels': ['TKA by gap technique', 'TKA by reversed gap technique']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Georg Matziolis, MD', 'role': 'CONTACT', 'email': 'g.matziolis@krankenhaus-eisenberg.de', 'phone': '+49 36691 81010'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jena', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Orthopaedic Department', 'investigatorFullName': 'Georg Matziolis', 'investigatorAffiliation': 'University of Jena'}}}}