Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-30 @ 5:27 AM
Study NCT ID:
NCT03570606
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-04
First Post:
2018-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of Bone Graft Substitutes in Orthopaedic and Spinal Applications.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2018-06-18', 'studyFirstSubmitQcDate': '2018-06-18', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary endpoints will be successful radiographic bone repair.', 'timeFrame': '12 months', 'description': 'Bone formation and material resorption, observable by x-ray/MRI'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Deformity']}, 'descriptionModule': {'briefSummary': 'This is an observational, prospective, non-randomised, multi-centred post market clinical follow-up study to compile real world clinical data on safety and efficacy of the synthetic bone graft substitutes in a commercial clinical setting in long bone and extremity defects and in spinal fusion procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'male or female 18-80 meeting the inclusion criteria, provided no exclusion criteria are met:', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nLong Bone and Extremity Indications: patients requiring bone grafting after post-traumatic or surgically created bone defects afflicting the long bones and extremities.\n\nSpine Indication: patients with degenerative disc disease or trauma who require spinal fusion of 1 or more vertebral bodies and where conservative treatment has been unsuccessful.\n\nPatients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center;\n\nExclusion Criteria:\n\nPatients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.\n\nWomen of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion); The subject is unable or not willing to complete follow-up visits and examination for the duration of the study."}, 'identificationModule': {'nctId': 'NCT03570606', 'acronym': 'ROSA', 'briefTitle': 'Clinical Study of Bone Graft Substitutes in Orthopaedic and Spinal Applications.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ceramisys Ltd'}, 'officialTitle': 'A Multi-centred, Post-market Clinical Follow-up Study of Synthetic Bone Graft Substitutes for Use in Orthopaedic and Spinal Applications.', 'orgStudyIdInfo': {'id': 'ROSA01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HA Paste in Spine', 'description': 'Evaluation of HA Paste in spinal fusion procedures\n\no Spinal cage filling', 'interventionNames': ['Device: bone graft substitute']}, {'label': 'HA Paste in long bone & extremities', 'description': 'Evaluation of HA Paste in long bone and extremity group:\n\n* Filling bone defects after cyst removal\n* Filling distal radius fractures\n* Filling defects such as tibial plateau fractures\n* Filling defects created by osteotomy procedures', 'interventionNames': ['Device: bone graft substitute']}, {'label': 'Granulated Paste in Spine', 'description': 'Evaluation of Granulated Paste in spinal fusion procedures\n\no Spinal cage filling', 'interventionNames': ['Device: bone graft substitute']}, {'label': 'Granulated Paste in long bone & extremities', 'description': 'Evaluation of Granulated Paste in long bone and extremity group:\n\n* Filling bone defects after cyst removal\n* Filling distal radius fractures\n* Filling defects such as tibial plateau fractures\n* Filling defects created by osteotomy procedures', 'interventionNames': ['Device: bone graft substitute']}, {'label': 'Granules in Spine', 'description': 'Evaluation of Granules in spinal fusion procedures\n\no Spinal cage filling', 'interventionNames': ['Device: bone graft substitute']}, {'label': 'Granules in long bone & extremities', 'description': 'Evaluation of Granules in long bone and extremity group:\n\n* Filling bone defects after cyst removal\n* Filling distal radius fractures\n* Filling defects such as tibial plateau fractures\n* Filling defects created by osteotomy procedures', 'interventionNames': ['Device: bone graft substitute']}, {'label': 'Block in long bone & extremities', 'description': 'Evaluation of Blocks in long bone and extremity group:\n\no High tibial osteotomies with fixation', 'interventionNames': ['Device: bone graft substitute']}], 'interventions': [{'name': 'bone graft substitute', 'type': 'DEVICE', 'description': 'orthopaedic or spine bony defects', 'armGroupLabels': ['Block in long bone & extremities', 'Granulated Paste in Spine', 'Granulated Paste in long bone & extremities', 'Granules in Spine', 'Granules in long bone & extremities', 'HA Paste in Spine', 'HA Paste in long bone & extremities']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DN2 5LT', 'city': 'Doncaster', 'state': 'South Yorkshire', 'country': 'United Kingdom', 'facility': 'Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.52285, 'lon': -1.13116}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Sandwell and West Birmingham NHS Trust of City Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'The Royal Orthopaedic Hospital NHS Foundation Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'North Shields', 'country': 'United Kingdom', 'facility': 'Northumbria Healthcare NHS Foundation Trust', 'geoPoint': {'lat': 55.01646, 'lon': -1.44925}}, {'city': 'Salford', 'country': 'United Kingdom', 'facility': 'Salford Royal NHS Foundation Trust', 'geoPoint': {'lat': 53.48771, 'lon': -2.29042}}, {'city': 'Stoke-on-Trent', 'country': 'United Kingdom', 'facility': 'University Hospitals of North Midlands NHS Trust', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}, {'city': 'Taunton', 'country': 'United Kingdom', 'facility': 'Taunton and Somerset NHS Foundation Trust', 'geoPoint': {'lat': 51.01494, 'lon': -3.10293}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ceramisys Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}