Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-01-01 @ 9:35 PM
Study NCT ID:
NCT06899932
Status:
RECRUITING
Last Update Posted:
2025-03-28
First Post:
2025-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Survival Study of the Genutech® Total Knee Arthroplasty
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2033-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2025-03-11', 'studyFirstSubmitQcDate': '2025-03-27', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients without revision surgery', 'timeFrame': '5 and 10 years', 'description': 'the main goal is to determine the implant survival, that is, having no revision during follow-up. The number of patients requiring revision will be compared to the total of patients included in the study.'}], 'secondaryOutcomes': [{'measure': 'Oxford Knee Score', 'timeFrame': 'one, 5 and 10 years', 'description': 'Clinical evaluation with Patient Reported Outome Measures (PROMs): Oxford Knee Score (OKS). OKS score is higher with good results and lower with bad results.'}, {'measure': 'SF12 questionnaire', 'timeFrame': '1, 5 and 10 years postoperatively', 'description': 'Clinical evaluation with Patient Reported Outome Measures (PROMs): SF12 questionnaire. SF12 scores are higher with good results and lower with bad results.'}, {'measure': 'WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionaire', 'timeFrame': 'One, 5 and 10 years', 'description': 'Clinical evaluation with Patient Reported Outome Measures (PROMs): WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionaire. WOMAC scores are higher with bad results and lower with good results.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total Knee Arthroplasty', 'Knee Osteoarthritis'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Prospective cohort sudy of patients undergoing a Genutech® total knee arthroplasty', 'detailedDescription': "A prospective cohort study will be performed collecting patient's data before and after the total knee arthroplasty surgical procedure at one, five and ten years. The main goal of this work is to prospectively study the results obtained with the implantation of the knee prosthesis currently used in the Orthopaedic Service of Sant Rafael Hospital of Barcelona (Genutech®). The main outcome of the study is the survival of the implant, that is, having no revision surgeries in the follow-up. The secondary objective is the clinical and radiological evaluation of the implants measured by outcome measueres: Oxford Knee Score (OKS), SF12 questionnaire and WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionaire. OKS and SF12 scores are higher with good results and lower with bad results. WOMAC expresses results the other way around."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients referred to the investigators' Institution by Primary Care centres to receive Orthopaedic care", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients older than 18 years with knee osteoarthritis that had not responded to conservative treatment\n* capable of providing informed consent\n* patients who receive a Genutech® total knee prosthesis at the investigators' Institution.\n\nExclusion Criteria:\n\n* having received a prior total knee arthroplasty in the same joint\n* inability to provide informed consent\n* not willing to participate in the study"}, 'identificationModule': {'nctId': 'NCT06899932', 'briefTitle': 'Survival Study of the Genutech® Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Sant Rafael'}, 'officialTitle': 'Survival Study of the Genutech® Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'PR-2021-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '08035', 'city': 'Barcelona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jordi Faig-Martí, MD, PhD', 'role': 'CONTACT', 'email': 'jfaigm.hsrafael@hospitalarias.es', 'phone': '+34932112508'}], 'facility': 'Hospital Sant Rafael', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Jordi Faig-Martí, MD, PhD', 'role': 'CONTACT', 'email': 'jfaigm.hsrafael@hospitalarias.es', 'phone': '+34932112508'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Sant Rafael', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}