Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-03-01 @ 8:32 AM
Study NCT ID:
NCT02802033
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2016-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter Prospective Registry for the Management of Degenerative Spine Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019636', 'term': 'Neurodegenerative Diseases'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 908}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-19', 'studyFirstSubmitDate': '2016-05-27', 'studyFirstSubmitQcDate': '2016-06-13', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Information on postoperative adverse events', 'timeFrame': 'Every standard of care scheduled follow-up visit up to 3 years', 'description': 'Data will be entered in the database but there is not yet defined how the data will be analysed. Data collected can help drive hypotheses and might help to answer unforeseen questions over time.'}, {'measure': 'Duration of postoperative adverse event', 'timeFrame': 'Every standard of care scheduled follow-up visit up to 3 years', 'description': 'Data will be entered in the database but there is not yet defined how the data will be analysed. Data collected can help drive hypotheses and might help to answer unforeseen questions over time.'}], 'primaryOutcomes': [{'measure': 'Use of Osteobiologics - Within the registry information on the use of osteobiologis (autografts, allografts, BMA/cells, BMP, DBM, matrices/carriers, platelets) are collected', 'timeFrame': 'Every standard of care scheduled follow-up visit up to 3 years', 'description': 'Osteobiologics are classified as autogenous bone graft substitutes, extenders, or enhancers. Types of osteobiologics include demineralized bone matrices (DBM), allografts and allograft formulations, synthetic bone grafts, bone morphogenic proteins, bone marrow aspirate systems, stem cells and platelet-rich plasma systems. The biologics are generally defined as being derived from or replicating natural substances. The osteobiologics are defined as such by possessing one or more of the following properties: osteoinductivity, osteoconductivity, and osteogenicity. Although biologics are classically defined as being derived from or replicating natural substances, a broader definition of an osteobiologic includes synthetic derivatives that may not replicate natural substances, but serve as a bone graft substitute, extender or enhancer.\n\nThere is not yet defined how the data will be analysed. Data collected can help drive hypotheses and might help to answer unforeseen questions over time.'}], 'secondaryOutcomes': [{'measure': 'Neck, Arm, Back, Leg, Thoracic pain Numeric Rating Scale (NRS)', 'timeFrame': 'Every standard of care scheduled follow-up visit up to 3 years'}, {'measure': 'Neck Disability Index (NDI)', 'timeFrame': 'Every standard of care scheduled follow-up visit up to 3 years'}, {'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': 'Every standard of care scheduled follow-up visit up to 3 years'}, {'measure': 'Euroqol EQ-5D-3L', 'timeFrame': 'Every standard of care scheduled follow-up visit up to 3 years'}, {'measure': 'Short Form (SF)-36 V2', 'timeFrame': 'Every standard of care scheduled follow-up visit up to 3 years'}, {'measure': 'Modified Zung Depression Index', 'timeFrame': 'Every standard of care scheduled follow-up visit up to 3 years'}, {'measure': 'Distress and Risk Assessment Method (DRAM)', 'timeFrame': 'Every standard of care scheduled follow-up visit up to 3 years'}, {'measure': 'Scoliosis Research Society (SRS)-22 Questionnaire', 'timeFrame': 'Every standard of care scheduled follow-up visit up to 3 years'}, {'measure': 'Modified Japanese Orthopedic Association Score (mJOA)', 'timeFrame': 'Every standard of care scheduled follow-up visit up to 3 years'}, {'measure': 'Type of fusion that was performed (posterior and/or anterior/interbody fusion)', 'timeFrame': '6 months after surgery, if this time point is collected as per standard of care', 'description': 'Data will be entered in the database but there is not yet defined how the data will be analysed. Data collected can help drive hypotheses and might help to answer unforeseen questions over time.'}, {'measure': 'Type of fusion that was performed (posterior and/or anterior/interbody fusion)', 'timeFrame': '12 months after surgery, if this time point is collected as per standard of care', 'description': 'Data will be entered in the database but there is not yet defined how the data will be analysed. Data collected can help drive hypotheses and might help to answer unforeseen questions over time.'}, {'measure': 'Fusion: Bridging trabecular bone across the segment, bone graft resorption, implant subsidence/migration, fatigue failure of spinal instrumentation, radioluciencies around screws, instability on flexion/extension views', 'timeFrame': '6 months after surgery, if this time point is collected as per standard of care', 'description': 'Radiological source for interpretation (Clinical assessment, radiographs, CT, MRI, bone scan, other) Data will be entered in the database but there is not yet defined how the data will be analysed. Data collected can help drive hypotheses and might help to answer unforeseen questions over time.'}, {'measure': 'Fusion: Bridging trabecular bone across the segment, bone graft resorption, implant subsidence/migration, fatigue failure of spinal instrumentation, radioluciencies around screws, instability on flexion/extension views', 'timeFrame': '12 months after surgery, if this time point is collected as per standard of care', 'description': 'Radiological source for interpretation (Clinical assessment, radiographs, CT, MRI, bone scan, other) Data will be entered in the database but there is not yet defined how the data will be analysed. Data collected can help drive hypotheses and might help to answer unforeseen questions over time.'}, {'measure': 'Success of fusion', 'timeFrame': '6 months after surgery, if this time point is collected as per standard of care', 'description': 'Data will be entered in the database but there is not yet defined how the data will be analysed. Data collected can help drive hypotheses and might help to answer unforeseen questions over time.'}, {'measure': 'Success of fusion', 'timeFrame': '12 months after surgery, if this time point is collected as per standard of care', 'description': 'Data will be entered in the database but there is not yet defined how the data will be analysed. Data collected can help drive hypotheses and might help to answer unforeseen questions over time.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Registry', 'Spine', 'Osteobiologics', 'Spinal Fusion'], 'conditions': ['Degenerative Diseases, Spinal Cord']}, 'descriptionModule': {'briefSummary': 'Details regarding the degenerative spine disorders will be collected with a specific focus on the use of osteobiologics in treating degenerative conditions and their impact on fusion, as well as patient-reported outcomes for these conditions.', 'detailedDescription': 'The registry is designed to be open-ended. However, a statistical evaluation of the content und structure of database and CRFs in order to investigate the feasibility and quality of data collection is planned to take place prior to the registry expansion.\n\nVariables applicable to patients with a degenerative spine disorder which will be collected in the registry include:\n\n* Patient details\n* Symptoms\n* Diagnosis\n* Imaging assessment\n* Treatment details\n\nFeasibility phase:\n\nThe statistical evaluation of the feasibility and quality of data collection will be performed after the first 5 sites have each enrolled 12 patients with a degenerative pathology and documented one follow-up visit. During this evaluation, enrolment of further patients can be continued.\n\nBased on the findings of this feasibility phase, adjustments to the existing database can be performed before the registry is rolled out on larger scale.\n\nRegistry expansion:\n\nFollowing the evaluation process of the feasibility phase, the registry will be expanded to allow data entry in more sites globally. Multi-site participation of this registry will be rolled-out in stages, and will be offered to sites with appropriate expertise which are selected based on their potential (interest, resources and expected patient volume).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a degenerative spine disorder', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged 18 years or older\n* Patient diagnosed with a degenerative spine disorder who receives treatment for the degenerative spine disorder\n* Patient capable of understanding the content of the patient information / Informed Consent Form\n* Patient willing and able to participate in the registry\n* Patient who has agreed to participate in the registry by providing consent according to the applicable local law and the declaration of Helsinki\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02802033', 'briefTitle': 'A Multicenter Prospective Registry for the Management of Degenerative Spine Disorders', 'organization': {'class': 'OTHER', 'fullName': 'AO Innovation Translation Center'}, 'officialTitle': 'DegenPRO: A Multicenter Prospective Registry for the Management of Degenerative Spine Disorders', 'orgStudyIdInfo': {'id': 'DegenPRO'}}, 'contactsLocationsModule': {'locations': [{'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC Spine Center, Keck Medical Center of USC', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian - Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '06112', 'city': 'Halle', 'country': 'Germany', 'facility': 'BG-Clinic Bergmannstrost', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '40136', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Istituto Ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Tim Yoon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Principal Coordinating Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AO Innovation Translation Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'AO Foundation, AO Spine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}