Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT04076202
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2019-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Vanguard DD RP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-11-18', 'releaseDate': '2024-09-12'}], 'estimatedResultsFirstSubmitDate': '2024-09-12'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-16', 'studyFirstSubmitDate': '2019-08-23', 'studyFirstSubmitQcDate': '2019-08-30', 'lastUpdatePostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance', 'timeFrame': '2 years', 'description': 'The performance will be assessed by evaluation of the rate of aseptic loosening of femoral or tibial components within 2 years follow up.'}], 'secondaryOutcomes': [{'measure': 'Patient benefits', 'timeFrame': '10 years', 'description': 'Patient benefit will be evaluated by means of Knee injury and Osteoarthritis Outcome Score (KOOS). The KOOS evaluates both short-term and long-term consequences of knee injury.The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.'}, {'measure': 'Patient benefits', 'timeFrame': '10 years', 'description': "Patient benefit will be evaluated by means of European Quality of Life (EuroQol) in 5 Dimensions (EQ-5D) patient questionnaire. The questionnaire contains a descriptive system and the EQ Visual Analogue scale (VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. Higher EQ-5D score values indicate better outcome."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee replacement', 'Knee Osteoarthritis'], 'conditions': ['Knee Osteoarthritis', 'Post-traumatic Osteoarthritis', 'Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This is a single cohort, prospective study of performance and safety of the Vanguard Deep Dish Rotating Platform (DD RP) cementless fixation with the goal to acquire clinical outcomes data and evaluate the performance of the device in an Austrian patient population', 'detailedDescription': 'This is a single cohort, prospective study of performance and safety of the Vanguard Deep Dish Rotating Platform (DD RP) - cementless fixation with finned stem. The performance will be assessed by Oxford Knee Score, and evaluation of aseptic loosening after 2 years follow up. Patient benefit will be evaluated by means of Knee injury and Osteoarthritis Outcome Score (KOOS) and EQ-5D patient questionnaire. The target enrollment is 113 patients in 1 clinical site in Linz, Austria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled to undergo primary total knee replacement:\n\n * with painful and disabled knee joint resulting from any of the following diagnoses:\n * Osteoarthritis,\n * Traumatic arthritis,\n * Rheumatoid arthritis with one or more compartments involved.\n * Correction of varus, valgus, or posttraumatic deformity.\n * Correction or revision of unsuccessful osteotomy or arthrodesis.\n* Need to obtain pain relief and improve function.\n* Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations.\n* A good nutritional state of the patient.\n* Full skeletal maturity of the patient, patients who are at least 18 years of age.\n* Patients of either sex.\n* Consent form read, understood, and signed by patient.\n\nExclusion Criteria:\n\n* Absolute contraindications include the following diagnoses:\n\n * Infection\n * Osteomyelitis\n * Previous partial or total prosthetic knee replacement on the operative side\n * Skeletal immaturity of the patient\n * Sepsis\n * Patients who are less than 18 years of age\n* Relative contraindications include:\n\n * uncooperative patient or patient with neurologic disorders who are incapable of following directions,\n * osteoporosis,\n * metabolic disorders which may impair bone formation,\n * osteomalacia,\n * distant foci of infections which may spread to the implant site,\n * rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,\n * vascular insufficiency, muscular atrophy, neuromuscular disease,\n * incomplete or deficient soft tissue surrounding the knee'}, 'identificationModule': {'nctId': 'NCT04076202', 'briefTitle': 'Clinical Evaluation of Vanguard DD RP', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'Clinical Evaluation of Vanguard Deep Dish Rotating Platform Knee - Cementless Fixation With Finned Stem', 'orgStudyIdInfo': {'id': 'BMETEU.CR.EU 13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cementless Vanguard DD RP', 'description': 'Patients receiving a total knee prosthesis', 'interventionNames': ['Device: Cementless Vanguard DD RP']}], 'interventions': [{'name': 'Cementless Vanguard DD RP', 'type': 'DEVICE', 'description': 'Patients treated with the Cementless Vanguard DD RP knee implant', 'armGroupLabels': ['Cementless Vanguard DD RP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4021', 'city': 'Linz', 'country': 'Austria', 'facility': 'Kepler Universitäts Klinikum', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}], 'overallOfficials': [{'name': 'Sabine Illi, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinical Evidence Manager'}, {'name': 'Tobias Gotterbarm, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kepler Universitäts Klinikum'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-09-12', 'type': 'RELEASE'}, {'date': '2024-11-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Zimmer Biomet'}}}}