Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT03063593
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2017-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UK Infinity, Post-Market Clinical Follow-up Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-06', 'size': 714275, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-11-08T09:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-08', 'studyFirstSubmitDate': '2017-02-15', 'studyFirstSubmitQcDate': '2017-02-23', 'lastUpdatePostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Outcome Measure survivorship at 10 years', 'timeFrame': '10 Years', 'description': 'The primary outcome measure of this post-market clinical observational study is to collect data relating to the INFINITY® Total Ankle System performance/survivorship at up to 10 years.'}], 'secondaryOutcomes': [{'measure': 'EQ5D-EuroQol-questionnaire', 'timeFrame': 'From pre-op through 10 years', 'description': 'Compare the improvement in self-reported pain and social interaction for quality of life measures'}, {'measure': 'Ankle Osteoarthritis Score (AOS)-questionnaire', 'timeFrame': 'From Pre-op through 10 years', 'description': 'Self-reported to compare pain and functional improvement, which is a visual analogue scale specifically designed as a modification of the Foot function Index'}, {'measure': 'Manchester Oxford Foot Questionnaire (MOXFQ)-questionnaire', 'timeFrame': 'From Pre-op through 10 years', 'description': 'Compare the improvement in self-reported pain-free function scores (walking/standing scores)'}, {'measure': 'Radiographic evaluation-physician reported questionnaire', 'timeFrame': 'From Pre-op through 10 years', 'description': 'identify and assess the implant for component loosening and/or subsidence, any osteolysis and/or cyst formation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthritis, Rheumatoid', 'Post-traumatic Osteoarthritis', 'Degenerative Arthritis']}, 'descriptionModule': {'briefSummary': 'Study Title UK Post-Market Clinical Follow-Up Of The INFINITY® Total Ankle System Study Design Prospective, multi-site, multi-year post-market clinical follow-up study Study Group Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY® Total Ankle System Number of Subjects 500 with 10 sites', 'detailedDescription': 'Study Title UK Post-Market Clinical Follow-Up Of The INFINITY® Total Ankle System Study Design Prospective, multi-site, multi-year post-market clinical follow-up study Study Group Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY® Total Ankle System N Subjects 500 with 10 sites Follow-Up Schedule Subject enrollment will consist of a Pre-operative, Operative, 6 months, 1 yr., 2 yr., 5yr., 7 yr., 10 yr., and an unscheduled visit as needed.\n\nPrimary Objective Evaluate the long-term survivorship of the INFINITY® implant over 10 years\n\nSecondary Objective(s) Secondary objectives assessed will be to:\n\n* Identify and assess the implant for component loosening and/or subsidence, any osteolysis and/or cyst formation through radiographic evaluation early and throughout the lifetime of the implant.\n* Compare the improvements in self-reported pain and social interaction for quality of life measures from pre-op through 10 years post operatively; assessed by EuroQol (EQ5D5L).\n* Compare pain and functional improvement in the Ankle Osteoarthritis Score (AOS), which is a visual analogue scale specifically designed as a modification of the Foot Function Index.\n* Compare the improvement in self-reported pain-free function scores from pre-op through 10 years post-operatively, assessed by the Manchester Oxford Foot Questionnaire (MOXFQ) walking/standing scores.\n* Identify and report the safety of the implant in terms of complications and adverse events.\n\nInclusion Criteria Subjects to be included in the study must meet all of the following criteria:\n\n* Be 21 years of age at the time of surgery;\n* Diagnosed with unilateral and/or bilateral ankle joint disease;\n* Diagnosed with ankle joint damage from rheumatoid arthritis, post-traumatic, or degenerative arthritis; Willing and able to consent to participate (written, informed consent / witnessed verbal consent) Willing and able to attend the requested follow-up visits;\n* Subjects determined by the Investigator to be an appropriate candidate for the INFINITY® Total Ankle System\n\nExclusion Criteria Subjects will be excluded from the study if they meet any of the following criteria:\n\n* Subjects with an ankle condition, as determined by the investigator, to be an inappropriate candidate for a total ankle replacement;\n* Subjects requiring revision total ankle replacement of the ankle being considered for study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY® Total Ankle System', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects to be included in the study must meet all of the following criteria:\n\n* Be 21 years of age at the time of surgery;\n* Diagnosed with unilateral and/or bilateral ankle joint disease;\n* Diagnosed with ankle joint damage from rheumatoid arthritis, post-traumatic, or degenerative arthritis; Willing and able to consent to participate (written, informed consent / witnessed verbal consent) Willing and able to attend the requested follow-up visits;\n* Subjects determined by the Investigator to be an appropriate candidate for the INFINITY® Total Ankle System\n\nExclusion Criteria:\n\nSubjects will be excluded from the study if they meet any of the following criteria:\n\n* Subjects with an ankle condition, as determined by the investigator, to be an inappropriate candidate for a total ankle replacement;\n* Subjects requiring revision total ankle replacement of the ankle being considered for study'}, 'identificationModule': {'nctId': 'NCT03063593', 'briefTitle': 'UK Infinity, Post-Market Clinical Follow-up Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stryker Trauma and Extremities'}, 'officialTitle': 'UK Multi-Centre, Observational, Post-Market Clinical Follow-up of the INFINITY® Total Ankle System', 'orgStudyIdInfo': {'id': 'UK15-TAR-001'}}, 'contactsLocationsModule': {'locations': [{'zip': 'TQ2 7AA', 'city': 'Torquay', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'Torbay and South Devon NHS Foundation Trust', 'geoPoint': {'lat': 50.46198, 'lon': -3.52522}}, {'zip': 'BH7 7DW', 'city': 'Bournemouth', 'state': 'Dorset', 'country': 'United Kingdom', 'facility': 'Royal Bournemouth Hosptial', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'zip': 'G71 8BB', 'city': 'Bothwell', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'NHS Lanarkshire', 'geoPoint': {'lat': 55.80272, 'lon': -4.06835}}, {'zip': 'SY10 7AG', 'city': 'Oswestry', 'state': 'Shropshire', 'country': 'United Kingdom', 'facility': 'RJAH Hospital NHS FT', 'geoPoint': {'lat': 52.86195, 'lon': -3.05497}}, {'zip': 'S5 7AU', 'city': 'Sheffield', 'state': 'South Yorksire', 'country': 'United Kingdom', 'facility': 'Sheffield Teaching Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'BS105NB', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'North Bristol NHS Trust', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'EH16 4SA', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Royal Infirmary of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'EX2 5DW', 'city': 'Exeter', 'country': 'United Kingdom', 'facility': 'Royal Devon and Exeter NHS Foundation Trust', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'zip': 'HA7 4LP', 'city': 'Middlesex', 'country': 'United Kingdom', 'facility': 'Royal National Orthopaedic Hospital NHS Trust', 'geoPoint': {'lat': 51.53174, 'lon': -0.26856}}, {'zip': 'NE29 8NH', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Northumbria Healthcare NHS Foundation Trust', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'NG5 1PB', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'WN6 9EP', 'city': 'Wigan', 'country': 'United Kingdom', 'facility': 'Wrightington Hospital', 'geoPoint': {'lat': 53.54296, 'lon': -2.63706}}], 'overallOfficials': [{'name': 'David Townshend, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Northumbria Trust'}, {'name': 'Rebecca Gibson', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Stryker Trauma & Extremeties'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stryker Trauma and Extremities', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}