Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-31 @ 3:20 AM
Study NCT ID:
NCT05231304
Status:
COMPLETED
Last Update Posted:
2024-02-21
First Post:
2022-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000844', 'term': 'Ankylosis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-19', 'studyFirstSubmitDate': '2022-01-27', 'studyFirstSubmitQcDate': '2022-01-28', 'lastUpdatePostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subsequent Surgical Intervention', 'timeFrame': 'Up to 3 years.', 'description': 'The primary safety outcome measure is rate of subsequent surgical intervention (SSI), as defined as any surgical procedure or service required after the initial implant of the TTR device.'}, {'measure': 'Adverse Events (AEs)/Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 3 years.', 'description': 'Safety outcome measures by occurrence of adverse events (AEs), device- or procedure related AEs, and serious AEs.'}], 'primaryOutcomes': [{'measure': 'Improvement in pain from pre-operative baseline', 'timeFrame': '12-months', 'description': 'Primary probable benefit endpoint is improvement in pain at 12 months from preoperative baseline.'}], 'secondaryOutcomes': [{'measure': 'Improvement in Patient Reported Outcomes', 'timeFrame': '3 months', 'description': 'Secondary probably benefit endpoints will include patient reported functional outcome measures'}, {'measure': 'Improvement in Patient Reported Outcomes', 'timeFrame': '6 months', 'description': 'Secondary probably benefit endpoints will include patient reported functional outcome measures'}, {'measure': 'Improvement in Patient Reported Outcomes', 'timeFrame': '12 months', 'description': 'Secondary probably benefit endpoints will include patient reported functional outcome measures'}, {'measure': 'Improvement in Patient Reported Outcomes', 'timeFrame': '24 months', 'description': 'Secondary probably benefit endpoints will include patient reported functional outcome measures'}, {'measure': 'Improvement in Patient Reported Outcomes', 'timeFrame': '36 months', 'description': 'Secondary probably benefit endpoints will include patient reported functional outcome measures'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Retrospective Study', 'Ankle Joint', 'Talus', 'Arthrodesis', 'Printing, Three-Dimensional', 'Joint Prosthesis', 'Prosthesis Design'], 'conditions': ['Talus', 'Ankle Arthropathy']}, 'descriptionModule': {'briefSummary': 'This study is a retrospective analysis of patients who underwent surgery using a total talus replacement (TTR) implant with or without concurrent total ankle replacement and/or subtalar fusion. This study seeks to analyze the clinical and radiographic outcomes of TTR implant recipients and generate additional data on the safety and benefit of the TTR implant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients who underwent surgery involving a TTR implant with or without total ankle replacement and/or subtalar fusion between 1/1/2019 and 01/28/2022 will be will be included in this retrospective review. Patients with at least one postoperative follow-up visit will be included in this study. Only data in existence as of 01/28/2022 will be collected.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 Years of Age\n* Patient underwent surgery involving a total talus replacement implant between 1/1/2019 and 01/28/2022.\n\nExclusion Criteria:\n\n* No available postoperative data'}, 'identificationModule': {'nctId': 'NCT05231304', 'acronym': 'RECLAIM', 'briefTitle': 'Retrospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Restor3D'}, 'officialTitle': 'Retrospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement', 'orgStudyIdInfo': {'id': 'restor3d-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Total Talus Replacement', 'interventionNames': ['Procedure: Total Talus Replacement (TTR)']}, {'label': 'Total Ankle Total Talus Replacement', 'interventionNames': ['Procedure: Total Ankle Total Talus Replacement (TATTR)']}, {'label': 'Total Ankle Total Talus Replacement + Subtalar Fusion', 'interventionNames': ['Procedure: Total Ankle Total Talus Replacement + Subtalar Fusion (TATTR + STJ)']}, {'label': 'Total Talus Replacement + Subtalar Fusion', 'interventionNames': ['Procedure: Total Talus Replacement + Subtalar Fusion (TTR + STJ)']}], 'interventions': [{'name': 'Total Talus Replacement (TTR)', 'type': 'PROCEDURE', 'description': "Surgical implantation of restor3d's patient-specific custom Total Talus Replacement device.", 'armGroupLabels': ['Total Talus Replacement']}, {'name': 'Total Ankle Total Talus Replacement (TATTR)', 'type': 'PROCEDURE', 'description': "Surgical implantation of restor3d's patient-specific custom Total Ankle Total Talus Replacement (TATTR) device.", 'armGroupLabels': ['Total Ankle Total Talus Replacement']}, {'name': 'Total Ankle Total Talus Replacement + Subtalar Fusion (TATTR + STJ)', 'type': 'PROCEDURE', 'description': "Surgical implantation of restor3d's patient-specific custom Total Ankle Total Talus Replacement (TATTR) device with concurrent subtalar fusion.", 'armGroupLabels': ['Total Ankle Total Talus Replacement + Subtalar Fusion']}, {'name': 'Total Talus Replacement + Subtalar Fusion (TTR + STJ)', 'type': 'PROCEDURE', 'description': "Surgical implantation of restor3d's patient-specific custom Total Talus Replacement (TTR) device with concurrent subtalar fusion.", 'armGroupLabels': ['Total Talus Replacement + Subtalar Fusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42001', 'city': 'Paducah', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Orthopaedic Institute of Western Kentucky', 'geoPoint': {'lat': 37.08339, 'lon': -88.60005}}, {'zip': '44811', 'city': 'Bellevue', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Bellevue Hospital', 'geoPoint': {'lat': 41.27366, 'lon': -82.84158}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Restor3D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}