Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-26 @ 9:40 PM
Study NCT ID:
NCT04679857
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2020-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Substitution of the PCL in TKA With UC or PS Design
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-16', 'studyFirstSubmitDate': '2020-12-17', 'studyFirstSubmitQcDate': '2020-12-17', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ROM', 'timeFrame': '10 years', 'description': 'Range of motion'}, {'measure': 'Patient reported outcome', 'timeFrame': '10 years', 'description': 'Oxford Knee Score min 0 points (worst), max 48 points (best)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patient Reported Outcome', 'Knee Osteoarthritis', 'Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'RCT comparing UC and PS TKA', 'detailedDescription': 'RCT comparing TKA with either ultraconguent insert or posterior stabilized design for substitution of the posterior cruciate ligament'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* scheduled for TKA\n\nExclusion Criteria:\n\n* higher constraint needed'}, 'identificationModule': {'nctId': 'NCT04679857', 'briefTitle': 'Substitution of the PCL in TKA With UC or PS Design', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Substitution of the Posterior Cruciate Ligament in Total Knee Arthroplasty With Ultracongruent Insert or Posterior Stabilzed Design', 'orgStudyIdInfo': {'id': 'TKA UC PS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UC', 'description': 'Total Knee Arthroplasty with an ultracongruent insert', 'interventionNames': ['Other: TKA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PS', 'description': 'Total Knee Arthroplasty with posterior stabilized design', 'interventionNames': ['Other: TKA']}], 'interventions': [{'name': 'TKA', 'type': 'OTHER', 'description': 'Total Knee Arthroplasty', 'armGroupLabels': ['PS', 'UC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'overallOfficials': [{'name': 'Jörg Lützner', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Carl Gustav Carus, TU Dresden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}