Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-02-23 @ 6:38 AM
Study NCT ID:
NCT02608957
Status:
TERMINATED
Last Update Posted:
2017-04-04
First Post:
2015-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Sponsor elected to terminate the study prior to subject treatment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-30', 'studyFirstSubmitDate': '2015-11-13', 'studyFirstSubmitQcDate': '2015-11-17', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Efficacy Endpoint: Mean change in KOOS pain score at 6 months', 'timeFrame': '6 Months', 'description': 'Mean change in KOOS pain score at 6 months after treatment with the Latella Implant.'}, {'measure': 'Primary Safety Endpoint: Surgical re-intervention rate at 6 months', 'timeFrame': '6 Months', 'description': 'Surgical re-intervention rate during the 6 month period following implantation of the Latella device.'}], 'secondaryOutcomes': [{'measure': 'Change in KOOS function score', 'timeFrame': '6, 12 and 24 months'}, {'measure': 'Change in medial knee pain NRS (while walking)', 'timeFrame': '6, 12 and 24 months'}, {'measure': 'Change in IKDC score', 'timeFrame': '6, 12 and 24 months'}, {'measure': 'Device-related complications rate', 'timeFrame': '24 months'}, {'measure': 'KOOS responder rate based on OARSI-OMERACT criteria', 'timeFrame': '6, 12 and 24 months'}, {'measure': 'Proportion of subjects reaching MCID in KOOS pain score', 'timeFrame': '6, 12 and 24 months'}, {'measure': 'Change in KOOS pain score', 'timeFrame': '12 and 24 months'}, {'measure': 'Surgical re-intervention rate', 'timeFrame': '12 and 24 months'}, {'measure': 'Procedure-related complications rate', 'timeFrame': '24 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The objective of the Latella-US study is to demonstrate the safety and efficacy of the Latella Knee Implant System for the reduction of medial osteoarthritis pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of pain due to medial osteoarthritis\n* Qualifying baseline pain scores\n* Kellgren-Lawrence Grades 2-3\n\nExclusion Criteria:\n\n* Osteoporosis\n* Rheumatoid arthritis\n* Joint instability\n* Metal ion allergy\n* Permanent implant in or around the knee joint\n* Prior anterior cruciate ligament reconstruction'}, 'identificationModule': {'nctId': 'NCT02608957', 'acronym': 'Latella-US', 'briefTitle': 'Evaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cotera, Inc.'}, 'officialTitle': 'Evaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-US Study)', 'orgStudyIdInfo': {'id': 'CIP-0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Latella Knee Implant System', 'interventionNames': ['Device: Latella Knee Implant System']}], 'interventions': [{'name': 'Latella Knee Implant System', 'type': 'DEVICE', 'armGroupLabels': ['Latella Knee Implant System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'The George Washington University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cotera, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}