Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-31 @ 2:38 AM
Study NCT ID:
NCT05013203
Status:
UNKNOWN
Last Update Posted:
2021-08-19
First Post:
2021-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NGS for Spine Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-13', 'studyFirstSubmitDate': '2021-08-13', 'studyFirstSubmitQcDate': '2021-08-13', 'lastUpdatePostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': '1 year', 'description': 'complications that patients experience after surgery will be noted from the patient chart after they have been evaluated by their surgeon'}, {'measure': 'Patient Satisfaction', 'timeFrame': '1 year', 'description': 'will be measured using the Short Form 12 Physical and Mental Score (SF-12)'}, {'measure': 'Patient pain', 'timeFrame': '1 year', 'description': 'will be measured using the Visual Analog Scale Neck and Arm Pain Score (VAS)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spine Infection']}, 'descriptionModule': {'briefSummary': 'During revision spinal surgery for aseptic indications, there remains a concern that the failure may have resulted from undetectable subclinical infection. In the common revision indications of hardware loosening and adjacent segment disease it is possible that bacterial colonization and low-grade infection precipitated the failure event. There is also significant controversy on the role infectious processes have in the development of degenerative disc disease (modic changes). In particular, this study will investigate whether discogenic colonization with Propionibacterium acnes (P. acnes) can be associated with modic changes. Whereas, in surgery for known spinal infection, epidural abscess and septic revisions, it is possible that standard culture techniques fail to detect polymicrobial flora or accurate speciation. This may lead to inappropriate antibiotic management that is not addressing the range of pathology present. There remains an incomplete understanding of the role that subclinical infection plays in aseptic spinal revision surgery and degenerative disc disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are having spine surgery who are \\>18 years old for degenerative disease, infection, and malignancy.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients \\>18 years of age undergoing spinal surgery\n\nExclusion Criteria:\n\n* All patients \\<18 years of age undergoing spinal surgery'}, 'identificationModule': {'nctId': 'NCT05013203', 'briefTitle': 'NGS for Spine Surgery Patients', 'organization': {'class': 'OTHER', 'fullName': 'Rothman Institute Orthopaedics'}, 'officialTitle': 'Next Generation Sequencing for the Detection of Clinical and Subclinical Infection in Patient Undergoing Spine Surgery', 'orgStudyIdInfo': {'id': 'CKEP21d.121'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Aseptic (uninfected) Revision Spine Surgery', 'description': 'Aseptic revision for indications including but not limited to hardware failure, adjacent segment pathology, radiculopathy, instability, cord compression.', 'interventionNames': ['Diagnostic Test: Tissue culture', 'Diagnostic Test: Next Generation Sequencing']}, {'label': 'Spine Surgery for Degenerative Disease', 'description': 'Primary degenerative pathology surgery where a disc sample is extracted to enable spinal decompression or fusion. The potential primary surgeries include but are not limited to microdiscectomy, laminectomy, and lumbar and cervical fusion', 'interventionNames': ['Diagnostic Test: Tissue culture', 'Diagnostic Test: Next Generation Sequencing']}, {'label': 'Septic (infected) Revision Spine Surgery', 'description': 'Spine surgery for known infection specifically: epidural abscess or septic revision. Epidural abscess must be managed surgically for inclusion. Septic revision cases include any surgery to address infected hardware from a previous spinal surgery.', 'interventionNames': ['Diagnostic Test: Tissue culture', 'Diagnostic Test: Next Generation Sequencing']}], 'interventions': [{'name': 'Tissue culture', 'type': 'DIAGNOSTIC_TEST', 'description': 'Discarded tissue collected during surgery will be sent to the hospital microbiological lab for aerobic and anaerobic', 'armGroupLabels': ['Aseptic (uninfected) Revision Spine Surgery', 'Septic (infected) Revision Spine Surgery', 'Spine Surgery for Degenerative Disease']}, {'name': 'Next Generation Sequencing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Discarded tissue collected during surgery will be sent to an outside lab for testing using next generation sequencing (NGS)', 'armGroupLabels': ['Aseptic (uninfected) Revision Spine Surgery', 'Septic (infected) Revision Spine Surgery', 'Spine Surgery for Degenerative Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rothman Orthopaedic Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rothman Institute Orthopaedics', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}