Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:06 AM
Study NCT ID:
NCT04629794
Status:
UNKNOWN
Last Update Posted:
2023-04-04
First Post:
2020-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The OsteoStrand Plus Deformity Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-30', 'studyFirstSubmitDate': '2020-11-05', 'studyFirstSubmitQcDate': '2020-11-10', 'lastUpdatePostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of fusion for the demineralized bone matrix cohort vs bone morphogenic protein cohort', 'timeFrame': '12 Months', 'description': 'Proportion of spinal levels in the demineralized bone matrix cohort vs bone morphogenic protein cohort achieving fusion.'}], 'secondaryOutcomes': [{'measure': 'Clinical outcomes', 'timeFrame': '24 Months', 'description': 'Oswestry Disability Index (ODI)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Fusion']}, 'descriptionModule': {'briefSummary': 'A clinical study evaluating outcomes for patients with spinal deformity.', 'detailedDescription': 'A clinical study evaluating deformity patients treated with Demineralized Bone Matrix as compared to patients treated with Bone Morphogenetic Protein.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n-≥18 years of age\n\n* Indicated for deformity correction surgery\n* Require spinal fusion at four or more levels\n* Are willing to return for follow-up visits\n* Willing to sign the Informed Consent Forms\n\nExclusion Criteria:\n\n* Uncontrolled diabetes\n* Morbid obesity\n* history of alcohol or drug abuse\n* Corticosteroid use\n* Fever or leukocytosis\n* Systemic infection\n* Active malignancy\n* Elevation of white blood cell count\n* Osteoporosis\n* Disease of bone metabolism\n* Unsuitable or insufficient bone support\n* Skeletal immaturity\n* Prior fusion\n* Use of steroids, immune suppressants, osteoporosis medications\n* Use of internal bone stimulators\n* Institutionalized or a prisoner\n* Undergoing (Undergone) a worker's compensation case\n* Pregnancy (includes women who are currently pregnant, lactating or wishing to become pregnant during the study duration)\n* Participation in another research study involving another implant, product or drug that may affect the outcomes of this clinical study within the last 30 days, or planned during this clinical study\n* Any other condition that the Investigator determines is unacceptable for enrollment into this clinical study"}, 'identificationModule': {'nctId': 'NCT04629794', 'briefTitle': 'The OsteoStrand Plus Deformity Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'SeaSpine, Inc.'}, 'officialTitle': 'The OsteoStrand Plus Deformity Study', 'orgStudyIdInfo': {'id': 'SS-OS-1802'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Demineralized Bone Matrix', 'description': 'Prospective cohort subjects undergoing deformity correction surgery that receive Demineralized Bone Matrix (DBM).', 'interventionNames': ['Procedure: Posterolateral Lumbar Fusion with Demineralized Bone Fibers']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bone Morphogenic Protein', 'description': 'Retrospective cohort subjects that underwent deformity correction surgery and received Bone Morphogenic Protein (BMP).', 'interventionNames': ['Procedure: Posterolateral Lumbar Fusion with Bone Morphogenic Protein']}], 'interventions': [{'name': 'Posterolateral Lumbar Fusion with Demineralized Bone Fibers', 'type': 'PROCEDURE', 'description': 'Posterolateral Lumbar Fusion with Demimeralized Bone Fibers', 'armGroupLabels': ['Demineralized Bone Matrix']}, {'name': 'Posterolateral Lumbar Fusion with Bone Morphogenic Protein', 'type': 'PROCEDURE', 'description': 'Posterolateral Lumbar Fusion with Bone Morphogenic Protein', 'armGroupLabels': ['Bone Morphogenic Protein']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85281', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Sonoran Spine', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}], 'overallOfficials': [{'name': 'Michael Chang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sonoran Spine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SeaSpine, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}