Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-03-06 @ 2:46 AM
Study NCT ID:
NCT02519218
Status:
COMPLETED
Last Update Posted:
2018-02-01
First Post:
2015-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ellipse Intramedullary High Tibial Osteotomy Nail Study
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-30', 'studyFirstSubmitDate': '2015-08-05', 'studyFirstSubmitQcDate': '2015-08-06', 'lastUpdatePostDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)', 'timeFrame': 'Participants will be followed through 2 years post-operative'}, {'measure': 'All non-serious adverse events in the limb related to the device or study procedure. Study procedure includes implant procedure and correction lengthening procedure.', 'timeFrame': 'Participants will be followed through 2 years post-operative'}, {'measure': 'Secondary surgical procedures', 'timeFrame': 'Participants will be followed through 2 years post-operative'}, {'measure': 'Surgical complications', 'timeFrame': 'Participants will be followed through 2 years post-operative'}], 'primaryOutcomes': [{'measure': 'Target vs. Actual Correction', 'timeFrame': 'Participants will be followed for the duration of correcting their deformity, an average of 3 weeks', 'description': 'Measured as either weight-bearing line (percent) or HKA angle (degrees)'}, {'measure': 'Target vs. Actual Correction', 'timeFrame': 'Participants will be followed for the duration of consolidation (bone healing), an average of 4 months', 'description': 'Measured as either weight-bearing line (percent) or HKA angle (degrees)'}], 'secondaryOutcomes': [{'measure': 'Change in Weight-Bearing Line', 'timeFrame': 'Participants will be followed for the duration of correcting their deformity, an average of 3 weeks', 'description': 'Measured in percent'}, {'measure': 'Change in Weight-Bearing Line', 'timeFrame': 'Participants will be followed for the duration of consolidation (bone healing), an average of 4 months', 'description': 'Measured in percent'}, {'measure': 'Change in Weight-Bearing Line', 'timeFrame': '1-year post-operative', 'description': 'Measured in percent'}, {'measure': 'Change in Weight-Bearing Line', 'timeFrame': '2-years post-operative', 'description': 'Measured in percent'}, {'measure': 'Change in Hip-Knee-Ankle Angle', 'timeFrame': 'Participants will be followed for the duration of correcting their deformity, an average of 3 weeks', 'description': 'Measured in degrees'}, {'measure': 'Change in Hip-Knee-Ankle Angle', 'timeFrame': 'Participants will be followed for the duration of consolidation (bone healing), an average of 4 months', 'description': 'Measured in degrees'}, {'measure': 'Change in Hip-Knee-Ankle Angle', 'timeFrame': '1-year post-operative', 'description': 'Measured in degrees'}, {'measure': 'Change in Hip-Knee-Ankle Angle', 'timeFrame': '2-years post-operative', 'description': 'Measured in degrees'}, {'measure': 'Change in Tibial Slope', 'timeFrame': 'Participants will be followed for the duration of correcting their deformity, an average of 3 weeks', 'description': 'Measured in degrees'}, {'measure': 'Change in Tibial Slope', 'timeFrame': 'Participants will be followed for the duration of consolidation (bone healing), an average of 4 months', 'description': 'Measured in degrees'}, {'measure': 'Change in Tibial Slope', 'timeFrame': '1-year post-operative', 'description': 'Measured in degrees'}, {'measure': 'Change in Tibial Slope', 'timeFrame': '2 years post-operative', 'description': 'Measured in degrees'}, {'measure': 'Time to full weight-bearing', 'timeFrame': 'Participants will be followed through 2 years post-operative', 'description': 'Measured in days'}, {'measure': 'Bone Healing', 'timeFrame': 'Participants will be followed for the duration of correcting their deformity, an average of 3 weeks', 'description': 'Graded 0 through 2, corresponding to Not Healing, Healing, and Healed'}, {'measure': 'Bone Healing', 'timeFrame': 'Participants will be followed for the duration of consolidation (bone healing), an average of 4 months', 'description': 'Graded 0 through 2, corresponding to Not Healing, Healing, and Healed'}, {'measure': 'Bone Healing', 'timeFrame': '1-year post-operative', 'description': 'Graded 0 through 2, corresponding to Not Healing, Healing, and Healed'}, {'measure': 'Bone Healing', 'timeFrame': '2 years post-operative', 'description': 'Graded 0 through 2, corresponding to Not Healing, Healing, and Healed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis', 'Varus Malalignment']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect outcomes data in patients implanted with the Ellipse IM HTO Nail System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients implanted with the Ellipse IM HTO Nail system for osteoarthritis and varus malalignment of the knee.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient implanted with the Ellipse IM HTO Nail System for osteoarthritis and varus malalignment of the knee\n* Patient signs informed consent for the use of their personal private data.\n\nExclusion Criteria:\n\n* Patient is currently enrolled in another clinical trial for high tibial osteotomy.'}, 'identificationModule': {'nctId': 'NCT02519218', 'briefTitle': 'Ellipse Intramedullary High Tibial Osteotomy Nail Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ellipse Technologies, Inc.'}, 'officialTitle': 'Outcomes Registry of Patients With Osteoarthritis and Varus Malalignment of the Knee Treated With Ellipse Intramedullary High Tibial Osteotomy (IM HTO) Nail System', 'orgStudyIdInfo': {'id': 'PR0179'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ellipse Technologies Intramedullary High Tibial Osteotomy Nail System', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mark Dahl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ellipse Technologies, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}