Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-25 @ 11:47 PM
Study NCT ID:
NCT03896451
Status:
WITHDRAWN
Last Update Posted:
2020-09-09
First Post:
2019-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Two Total Knee Prosthesis Medacta GMK Sphere and Medacta GMK PS
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': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Medacta GMK PS is not in use anymore', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2031-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-04', 'studyFirstSubmitDate': '2019-03-26', 'studyFirstSubmitQcDate': '2019-03-28', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Knee injury and Osteoarthritis Outcome Score', 'timeFrame': 'preoperative, 1 year, 5 year and 10 year after surgery', 'description': 'Knee injury and Osteoarthritis Outcome Score: 100 = maximum score, 0 = minimum score'}, {'measure': 'Change in Forgotten Joint Score', 'timeFrame': '1 year, 5 year and 10 year after surgery', 'description': 'Forgotten Joint Score: 100 = maximum score, 0 = minimum score'}], 'secondaryOutcomes': [{'measure': 'Change in revison', 'timeFrame': '1 year, 5 year and 10 year after surgery', 'description': 'Revision rate comparision with the baseline at 1 year'}, {'measure': 'Change in range of motion', 'timeFrame': 'preoperative, 1 year, 5 year and 10 year after surgery', 'description': 'Range of motion'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the clinical outcome after two total knee endoprosthesis designs Medacta GMK Sphere and Medacta GMK PS.\n\nPrimary outcome measures KOOS, Forgotten Knee Score and range of motion.\n\nSingle-center, randomized trial', 'detailedDescription': 'The clinical outcome measures were measured preoperativ and postoperativ (1 year, 5 year and 10 year).\n\nSecondary outcome measures: number of reoperations and revisions, survival of the prosthesis\n\nThe patient population would consist patients with knee osteoarthritis eligible for total knee replacement\n\nThe aim of the study is to evaluate the effect of the knee prosthesis design on the patient outcome'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient is eligible for a total knee replacement\n* patient is eligible for a Medacta GMK Sphere or Medacta GMK PS knee prosthesis\n* patient signed the informed consent\n\nExclusion Criteria:\n\n* patient is pregnant'}, 'identificationModule': {'nctId': 'NCT03896451', 'briefTitle': 'Comparison Between Two Total Knee Prosthesis Medacta GMK Sphere and Medacta GMK PS', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Winterthur KSW'}, 'officialTitle': 'Prospactive Randomized Monocentric Comparison Study Between Two Total Knee Prosthesis Medacta GMK Sphere and Medacta GMK PS', 'orgStudyIdInfo': {'id': 'PS vs. Sphere'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'GMK Sphere', 'description': 'Patients receiving total knee replacement surgery with the device "Medacta GMK Sphere"', 'interventionNames': ['Device: Total knee endoprothesis']}, {'type': 'OTHER', 'label': 'GMK PS', 'description': 'Patients receiving total knee replacement surgery with the device "Medacta GMK PS"', 'interventionNames': ['Device: Total knee endoprothesis']}], 'interventions': [{'name': 'Total knee endoprothesis', 'type': 'DEVICE', 'description': 'Total knee endoprosthesis after knee joint osteoarthritis', 'armGroupLabels': ['GMK PS', 'GMK Sphere']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8400', 'city': 'Winterthur', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Kantonsspital Winterthur', 'geoPoint': {'lat': 47.50564, 'lon': 8.72413}}], 'overallOfficials': [{'name': 'Peter Koch, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Principal Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kantonsspital Winterthur KSW', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator: PD/MD', 'investigatorFullName': 'Peter Koch', 'investigatorAffiliation': 'Kantonsspital Winterthur KSW'}}}}