Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT02270203
Status:
COMPLETED
Last Update Posted:
2019-08-06
First Post:
2014-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LOIS: Long-Term Follow-Up in INSITE/SIFI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-05', 'studyFirstSubmitDate': '2014-10-16', 'studyFirstSubmitQcDate': '2014-10-20', 'lastUpdatePostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject Success', 'timeFrame': '3 years on LOIS (5 years post-op)', 'description': 'Composite endpoint of success defined as improvement in VAS (Visual Analog Scale) recorded at SIFI or INSITE Baseline VAS back pain score by ≥20 mm; Absence of device-related SAE (Serious Adverse Events) ; Absence of neurological worsening related to the sacral spine,\\& Absence of surgical re-intervention on the target SI joint(s).'}, {'measure': 'Radiographic (CT) apposition of bone to sacral and iliac sides of implant', 'timeFrame': '3 years on LOIS (5 years post-op)', 'description': 'Proportion of subjects (with CT) who had at least 30% apposition of bone to sacral and iliac sides in at least 2 of 3 iFuse implants.'}], 'secondaryOutcomes': [{'measure': 'VAS (Visual Analog Scale)', 'timeFrame': '3 years on LOIS (5 years post-op)', 'description': 'Improvement in VAS (Visual Analog Scale), SI joint pain at follow-up visits.'}, {'measure': 'Oswestry Disability Index (ODI) Questionnaire', 'timeFrame': '3 years on LOIS (5 years post-op)', 'description': 'Improvement in Oswestry Disability Index (ODI) at follow-up visits.'}, {'measure': 'Improvement in quality of life (QOL)', 'timeFrame': '3 years on LOIS (5 years post-op)', 'description': 'Improvement in quality of life as measure by EQ-5D Questionnaire at follow-up visits.'}, {'measure': 'non-working subjects returning to work', 'timeFrame': '3 years on LOIS (5 years post-op)', 'description': 'Proportion of non-working subjects who return to work'}, {'measure': 'CT scans showing bridging bone', 'timeFrame': '3 years on LOIS (5 years post-op)', 'description': 'Proportion of CT scans that show bridging bone across the SI joint at 5 years post-operatively'}, {'measure': 'SAE (Serious Adverse Events) occurrence rate', 'timeFrame': '3 years on LOIS', 'description': 'Occurrence rate of serious adverse events.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['si joint', 'si joint injury', 'si joint treatment', 'si joint inflammation', 'si joint problems', 'si joint symptoms', 'hypermobile joint', 'si joint arthritis', 'si joint pain treatment', 'inflamed si joint', 'si joint sclerosis', 'locked si joint', 'si joint injuries', 'si joint disease', 'si joint infection', 'sacroiliac joint pelvic pain', 'sacroiliac joint arthritis treatment', 'si joint pain', 'si joint injections'], 'conditions': ['Degenerative Sacroilitis', 'Sacroiliac Joint Disruption']}, 'referencesModule': {'references': [{'pmid': '30214322', 'type': 'DERIVED', 'citation': 'Darr E, Cher D. Four-year outcomes after minimally invasive transiliac sacroiliac joint fusion with triangular titanium implants. Med Devices (Auckl). 2018 Aug 29;11:287-289. doi: 10.2147/MDER.S179003. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the long term safety and effectiveness of SI joint fusion using the iFuse Implant System in patients with degenerative sacroiliitis (DS) and/or sacroiliac joint disruptions (SD).\n\nStudy Design: This study is extended follow-up from two ongoing multicenter prospective US clinical trials. All participants have already undergone the surgical procedure of interest (SI joint fusion with iFuse Implant System). The two ongoing trials are:\n\n* SIFI:( Sacroiliac Joint Fusion with iFuse Implant System) a single-arm trial of patients with degenerative sacroiliitis or sacroiliac joint disruption who underwent iFuse placement, and\n* INSITE(Investigation of Sacroiliac Fusion Treatment): a randomized clinical trial of the same patient population who underwent either non-surgical treatment or iFuse placement'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with degenerative sacroiliitis or sacroiliac joint disruption who underwent iFuse placement.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient enrolled and treated in SIFI or patient initially randomized to iFuse and treated in INSITE. Note: Patient may be in the initial follow up period associated with SIFI or INSITE at the same time they consent for this study and "extend" their post-operative follow up.\n2. Patient has signed study-specific LOIS informed consent form.\n3. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements.\n\nExclusion Criteria:\n\n1. Treated with iFuse as a "crossover" in INSITE.\n2. Currently pregnant or planning pregnancy within 5 years of iFuse Implant.\n3. Patient is a prisoner or a ward of the state.\n4. Known or suspected active drug or alcohol abuse.\n5. Inadequately treated psychiatric illness (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation.\n6. Unwilling to perform the long-term follow up requirements of this study.\n7. Patient has any condition that could substantially prevent long-term follow-up.\n8. Unwilling to return to site at pre-specified study visits.'}, 'identificationModule': {'nctId': 'NCT02270203', 'acronym': 'LOIS', 'briefTitle': 'LOIS: Long-Term Follow-Up in INSITE/SIFI', 'organization': {'class': 'INDUSTRY', 'fullName': 'SI-BONE, Inc.'}, 'officialTitle': 'LOIS: Long-Term Follow-Up in INSITE/SIFI', 'orgStudyIdInfo': {'id': '300244'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pelvic CT at 5 years post-op', 'type': 'RADIATION', 'description': 'Pelvic CT at 5 years post-op'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '30281', 'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'Regenerative Orthopaedics and Spine Institute', 'geoPoint': {'lat': 33.54428, 'lon': -84.23381}}, {'zip': '62864', 'city': 'Mount Vernon', 'state': 'Illinois', 'country': 'United States', 'facility': 'Orthopaedic Center of Southern Illinois', 'geoPoint': {'lat': 38.31727, 'lon': -88.90312}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Bluegrass Orthopaedics & Hand Care', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '65201', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Columbia Orthopaedic Group', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '73159', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Center for Spine & Pain Solutions', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'MUSC', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75701', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Precision Spine Care', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '98004', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Overlake Hospital Medical Center', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '54311', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Aurora Research Institute', 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}, {'zip': '53132', 'city': 'Wauwatosa', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Integrated Spine Care', 'geoPoint': {'lat': 43.04946, 'lon': -88.00759}}], 'overallOfficials': [{'name': 'Daniel Cher, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SI-BONE, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SI-BONE, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}