Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-27 @ 7:06 AM
Study NCT ID:
NCT04727060
Status:
TERMINATED
Last Update Posted:
2024-07-16
First Post:
2020-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Label Study to Collect Clinical Data to Document Clinical Performance and Safety in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2146}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'the clinical data collected to date are sufficient for regulatory requirements', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-15', 'studyFirstSubmitDate': '2020-11-02', 'studyFirstSubmitQcDate': '2021-01-26', 'lastUpdatePostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of long-term survivorship of total knee replacement surgeries with HLS devices', 'timeFrame': '10-year', 'description': 'Implants survival'}], 'secondaryOutcomes': [{'measure': 'Evaluation of clinical performance', 'timeFrame': 'baseline (pre-surgery) to 10-year', 'description': 'Change of clinical performance using the International Knee Society (IKS) score'}, {'measure': 'Evaluation of patient satisfaction with the surgery', 'timeFrame': 'time up to 10-year FU', 'description': 'Patients satisfaction post-surgery and any change during time up to 10-year FU using satisfaction questionnaire'}, {'measure': 'Radiographic evaluation', 'timeFrame': 'baseline (1-year FU) to 10-year FU', 'description': 'Implant positioning and stability, presence/absence of progressive radiolucent lines around implant components, any sign of loosening components via radiological evaluation from baseline (1-year FU) to 10-year FU.'}, {'measure': 'Evaluation of safety of the study implants', 'timeFrame': 'time up to 10-year FU', 'description': 'Number, severity and causal relationship of procedure or implant-related Adverse Events (AEs) starting intraoperatively up to 10-year FU.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee Arthroplasty', 'Prosthesis', 'Implants', 'HLS implants', 'postero-stabilized prosthesis', 'third condyle', 'Arthroplasty'], 'conditions': ['Total Knee Arthroplasty', 'Knee Disease', 'Total Knee Replacement', 'Osteo Arthritis Knee']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate clinical performance and safety in total knee arthroplasty using HLS implants.', 'detailedDescription': 'It is planned to collect prospective and retrospective data from a continuous and exhaustive series of patients in a French center where Total Knee Arthroplasty with HLS prosthesis is performed routinely.\n\nAll patients treated with HLS KneeTec (cemented, non-cemented or hybrid versions) implant will be included. All eligible patients seen in consultation and who agree to participate in the study should be included, systematically and consecutively, since the initiation of the study.\n\nData will be collected retrospectively for HLS I, II, Evolution and Noetos® implants, and when prospectively for cementless, cemented and hybrid HLS KneeTec prosthesis.\n\nPost-surgery visit data will be collected at 1-y , 3-y , 5-y, 10-y FU visits per protocol then up to the latest FU visit available.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'It is planned to collect prospective and retrospective data from a continuous and exhaustive series of patients in a French center where Total Knee Arthroplasty with HLS prosthesis is performed routinely.\n\nAll patients treated with HLS KneeTec (cemented, non-cemented or hybrid versions) implant will be included. All eligible patients seen in consultation and who agree to participate in the study should be included, systematically and consecutively, since the initiation of the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For the HLS-1, HLS-2, HLS Evolution and HLS Noetos retrospective group:\n\n 1. Adult patients older than 18 years old.\n 2. Patients who have undergone routine preoperative clinical evaluations prior to their Total Knee Replacement surgery and implanted with one of the following prostheses from the HLS range: HLS-1, HLS-2, HLS Evolution and HLS Noetos between their first date of use in 1987 and their last date of use as normal practice at the participating site in accordance to indications and intended use as described in the Instruction for Use (IFU) of the study devices.\n 3. Patients who have been informed about their participation into an observational study.\n\nFor the HLS KneeTec prospective group (with retrospective surgeries):\n\n1. Adult patients older than 18 years old.\n2. Patients who have undergone routine preoperative clinical evaluations and received a TKR or are suitable candidates for a TKR with a fixed or mobile postero-stabilized HLS KneeTec prosthesis (cementless, cemented or hybrid combination) for the treatment of a primary or secondary knee osteoarthritis and inflammatory disease such as rheumatoid arthritis in accordance to indications and intended use as described in the Instruction for Use (IFU) of the study devices.\n3. Patients who are willing and able to complete the scheduled FU visits.\n4. Patients who have been informed about their participation into an observational registry study\n\nExclusion Criteria:\n\n* Patients mentally incompetent or unable to understand what participation in the study entails.\n* Patients who present signs and symptoms of any of the known contraindications described in the Instruction for Use (IFU) of the study devices.\n* Patients who deny their participation into the study.'}, 'identificationModule': {'nctId': 'NCT04727060', 'briefTitle': 'Open Label Study to Collect Clinical Data to Document Clinical Performance and Safety in Total Knee Arthroplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Corin'}, 'officialTitle': 'A Prospective and Retrospective, Open Label Study to Collect Clinical Data to Document Clinical Performance and Safety in Total Knee Arthroplasty Using HLS Implants', 'orgStudyIdInfo': {'id': '0904-T-KNEE-RM'}}, 'armsInterventionsModule': {'interventions': [{'name': 'patient with knee arthroplasty', 'type': 'DEVICE', 'otherNames': ['patient with HLS prosthesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69000', 'city': 'Lyon', 'country': 'France', 'facility': 'Hopital de la Croix-Rousse, Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Elvire SERVIEN, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de chirurgie orthopédique. Hopital de la Croix-Rousse, Hospices Civils de Lyon - France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corin', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}