Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-01-02 @ 7:52 PM
Study NCT ID:
NCT02039232
Status:
COMPLETED
Last Update Posted:
2019-04-17
First Post:
2014-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of the CarboFix Pedicle Screw System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy']}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}, {'id': 'D013168', 'term': 'Spondylolisthesis'}, {'id': 'D013130', 'term': 'Spinal Stenosis'}, {'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013169', 'term': 'Spondylolysis'}, {'id': 'D055009', 'term': 'Spondylosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2014-01-14', 'studyFirstSubmitQcDate': '2014-01-16', 'lastUpdatePostDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fusion success', 'timeFrame': '6 months post-operation'}]}, 'conditionsModule': {'conditions': ['Degenerative Disc Disease', 'Spondylolisthesis', 'Spinal Stenosis', 'Spinal Curvatures', 'Tumor']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the safety and efficacy of CarboFix' Pedicle Screw System in the lumbar spine."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject is 18 years old or older.\n2. Confirmation that the physical examination of radiopathy, myelopathy or combination is in correlation with the affected level.\n3. Lumbar CT, MRI, or myelography confirms the level of involvement is consistent with the subject's examination.\n4. Informed consent given by the subject.\n\nExclusion Criteria:\n\n1. Subject is not eligible for fixation with market-available fixation means.\n2. Familial history NF2.\n3. Acute traumatic spinal injury with or without neurological signs.\n4. Metabolic bone disease.\n5. History of Paget's disease or other osteodystrophies whether acquired or congenital, including renal osteodystrophy, hyperthyroidism, hypothyroidism hyperparathyroidism, Ehrlers-Danlos-syndrome, osteogenesis imperfecta, achondroplasia, tuberculosis.\n6. History of mental disorder or current psychiatric treatment.\n7. Pregnancy and/or female subjects intending to become pregnant within the expected time frame of the study and/or female subjects of child bearing age who do not use conventional contraceptive methods.\n8. Immune deficiency disease.\n9. Infection in the location of the operative site, discitis, osteomyelitis, fever and/or leukocytosis (as diagnosed based on the results of CBC and ESR tests).\n10. Scoliosis.\n11. Treatment with drugs that may interfere with bone metabolism such as:\n\n 1. Cumulative dose of 150 mg. of Prednisone or equivalent within the last 6 months.\n 2. Calcitonin within the past 6 months.\n 3. Bisphosphonates for 30 days or more within the last 12 months.\n 4. Bone therapeutic doses of fluoride for 30 days or more within the last 12 months.\n 5. Bone therapeutic doses of vitamin D or Vitamin D metabolites for 30 days or more within the last 6 months.\n 6. Treatment by chemotherapy within the last 12 months.\n12. Lack of willingness to make a commitment to return for required follow up visits.\n13. Drug and/or alcohol abuse.\n14. Morbid obesity.\n15. Metal allergies.\n16. Recent use of other investigational drugs or devices (within the past 30 days)."}, 'identificationModule': {'nctId': 'NCT02039232', 'briefTitle': 'Safety and Efficacy of the CarboFix Pedicle Screw System', 'organization': {'class': 'INDUSTRY', 'fullName': 'CarboFix Orthopedics Ltd.'}, 'officialTitle': 'CarboFix Pedicle Screw System', 'orgStudyIdInfo': {'id': 'CARBOFIX P CLD PPS1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CarboFix Pedicle Screw System', 'interventionNames': ['Device: Pedicle screw system']}], 'interventions': [{'name': 'Pedicle screw system', 'type': 'DEVICE', 'armGroupLabels': ['CarboFix Pedicle Screw System']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hadera', 'country': 'Israel', 'facility': 'Hillel Yafe MC;', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}, {'city': 'Herzliya', 'country': 'Israel', 'facility': 'Herzliya Medical Center', 'geoPoint': {'lat': 32.16627, 'lon': 34.82536}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CarboFix Orthopedics Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}