Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT02385968
Status:
TERMINATED
Last Update Posted:
2024-07-30
First Post:
2015-03-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Bacteria in Herniated Nucleus Material in Lumbar Disc Herniations by Culture and PCR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Biopsies of Nucleus'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Not possible to recruit', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-26', 'studyFirstSubmitDate': '2015-03-04', 'studyFirstSubmitQcDate': '2015-03-10', 'lastUpdatePostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacterial growth on a per-patient basis', 'timeFrame': 'at time of surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Modic', 'Microbiology', 'Immunology'], 'conditions': ['Lumbar Disc Herniations']}, 'descriptionModule': {'briefSummary': 'The aim is to investigate if herniated nucleus material in lumbar disc herniations is infected with bacteria, and if so, to determine their prevalence (control group), and to determine if patients with pre-existing Modic changes type 1 have a higher incidence of bacterial growth in relevant lumbar disc samples than patients without Modic changes.\n\nA cohort of 15 patients with pre-existing Modic and 15 without-undergoing primary surgery will be examined.', 'detailedDescription': 'The nucleus material will be evacuated and divided into 5 biopsies, each with a new set of sterile instruments and placed in separate sterile glass vials with one drop of sterile saline to prevent drying of biopsy.\n\nThe primary outcome, i.e., bacterial growth on a per-patient basis. Bacterial growth shall be detected in minimum 3 out of 5 biopsies for the patient to be scored as positive for bacteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with MRI-confirmed lumbar disc herniation. Lumbar disc herniation. Age between 18 and 65 years. No prior spine surgery. No diagnosed dementia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MRI-confirmed lumbar disc herniation.\n* Age between 18 and 65 years.\n* No prior spine surgery.\n* No diagnosed dementia.\n\nExclusion Criteria:\n\n* Antibiotic treatment within the previous two weeks.\n* History of alcohol abuse, illicit drug use or drug abuse, or significant mental illness\n* Known immune deficiency state (e.g., positive for human immunodeficiency virus) or in treatment with immunosuppressive drugs including high dose steroids or cyclosporine.\n* Concurrent infections (infections of skin, urinary tract infection, other skin diseases, e.g. Acne vulgaris).\n* Previous epidural instrumentation.\n* Uncontrolled, unstable or recently diagnosed autoimmune disease, including but not limited to systemic lupus erythematosus, inflammatory bowel disease, sarcoidosis, rheumatoid arthritis, or psoriasis.'}, 'identificationModule': {'nctId': 'NCT02385968', 'briefTitle': 'Detection of Bacteria in Herniated Nucleus Material in Lumbar Disc Herniations by Culture and PCR', 'organization': {'class': 'OTHER', 'fullName': 'Spine Centre of Southern Denmark'}, 'officialTitle': 'Detection of Bacteria in Herniated Nucleus Material in Lumbar Disc Herniations by Culture and PCR', 'orgStudyIdInfo': {'id': 'S-20140085'}}, 'contactsLocationsModule': {'locations': [{'zip': '5500', 'city': 'Middelfart', 'state': 'Region Syddanmark', 'country': 'Denmark', 'facility': 'Middelfart Spinesurgery research department', 'geoPoint': {'lat': 55.50591, 'lon': 9.73054}}], 'overallOfficials': [{'name': 'Karen H. Hansen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sygehus Lillebaelt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spine Centre of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vejle Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research nurse', 'investigatorFullName': 'Karen Højmark Hansen', 'investigatorAffiliation': 'Sygehus Lillebaelt'}}}}