Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-18 @ 1:34 AM
Study NCT ID:
NCT02104167
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2014-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tammy.stinson2@zimmerbiomet.com', 'phone': '303-501-8571', 'title': 'Clinical Affairs', 'organization': 'Zimmer Biomet'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This was a single-arm study that enrolled participants retrospectively. An active control is not available for comparison of results and changes from baseline are not available.'}}, 'adverseEventsModule': {'timeFrame': 'Date of surgery through last follow up visit, mean of 20.7 months', 'description': "Any change from baseline in a subject's condition during the clinical study. This includes events that are related to the device as well as events that are not related to the device.", 'eventGroups': [{'id': 'EG000', 'title': 'Operated Subjects With ROI-C Device', 'description': 'Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit.', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 42, 'seriousNumAtRisk': 110, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Upper extremity pain/numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 16, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall/Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neck Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shoulder injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pseudoarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cervical stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Fusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Operated Subjects With ROI-C Device', 'description': 'Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months or more after device implantation; mean follow up 20.7 months', 'description': 'Rate of fusion using A/P, lateral, and flexion/extension radiographs at each time point; defined by the presence of bridging bone with less than 2° segmental motion in flexion/extension and less than 3mm of A/P translation.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Operated Subjects With ROI-C Device', 'description': 'Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit.'}], 'classes': [{'title': 'NDI', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '72'}]}]}, {'title': 'VAS Neck', 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'VAS Left Arm', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '89'}]}]}, {'title': 'VAS Right Arm', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months (Last available visit) post surgery', 'description': 'NDI is a standard instrument for measuring self-rated disability due to neck pain. It is scored from 0-50, with results multiplied by 2 to arrive at a percentage. Lowest scores represent no disability, high scores represent worse disability. A VAS is a measurement instrument for pain that measures the degree across a continuum or straight line. The endpoints define extreme limits, from 0-10, with 0 representing no pain and 10 severe pain.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Operated Subjects'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Operated Subjects With ROI-C Device', 'description': 'Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Operated Subjects With ROI-C Device', 'description': 'Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '110', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.9', 'spread': '10.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-15', 'studyFirstSubmitDate': '2014-04-01', 'resultsFirstSubmitDate': '2017-11-07', 'studyFirstSubmitQcDate': '2014-04-03', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-15', 'studyFirstPostDateStruct': {'date': '2014-04-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Fusion', 'timeFrame': '12 months or more after device implantation; mean follow up 20.7 months', 'description': 'Rate of fusion using A/P, lateral, and flexion/extension radiographs at each time point; defined by the presence of bridging bone with less than 2° segmental motion in flexion/extension and less than 3mm of A/P translation.'}], 'secondaryOutcomes': [{'measure': 'Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain', 'timeFrame': '12 months (Last available visit) post surgery', 'description': 'NDI is a standard instrument for measuring self-rated disability due to neck pain. It is scored from 0-50, with results multiplied by 2 to arrive at a percentage. Lowest scores represent no disability, high scores represent worse disability. A VAS is a measurement instrument for pain that measures the degree across a continuum or straight line. The endpoints define extreme limits, from 0-10, with 0 representing no pain and 10 severe pain.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['DDD', 'degenerative disc disease', 'cervical spine', 'fusion rate'], 'conditions': ['Degenerative Disc Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this combined retrospective and prospective clinical study is to examine the clinical outcomes of the ROI-C® anterior cervical interbody fusion device with VerteBRIDGE® plating to treat single level degenerative disc disease between C2 and T1 in the short term, with a focus on fusion rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be drawn from community surgeon practices in which the subjects have already received the device and who meet the Inclusion/Exclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must have degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level between C2 and T1.\n* The subject can have the ROI-C device at only one level.\n* Autograft must have been used with the ROI-C device.\n* Subject should have had a minimum of 6 (six) weeks of non-operative treatment prior to surgery.\n* Subject must be at least 21 years of age at the time of surgery\n\nExclusion Criteria:\n\n* No BMP was used in the interbody cage\n* Subject was a prisoner at the time of surgery\n* Subject was pregnant at the time of surgery\n* Subject had an active infection or sepsis at the time of surgery'}, 'identificationModule': {'nctId': 'NCT02104167', 'briefTitle': 'Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating', 'organization': {'class': 'INDUSTRY', 'fullName': 'LDR Spine USA'}, 'officialTitle': 'An Open-Label Clinical Study of the Safety and Efficacy of the ROI-C Anterior Cervical Interbody Fusion Device Using the VerteBRIDGE Plating System', 'orgStudyIdInfo': {'id': 'ROIC100'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Operated Subjects', 'description': 'ROIC interbody cage with VerteBRIDGE plating', 'interventionNames': ['Device: ROIC interbody cage with VerteBRIDGE plating']}], 'interventions': [{'name': 'ROIC interbody cage with VerteBRIDGE plating', 'type': 'DEVICE', 'armGroupLabels': ['Operated Subjects']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Neurological Associates', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'city': 'Munster', 'state': 'Indiana', 'country': 'United States', 'facility': 'Orthpedic Specialists of Northwest Indiana', 'geoPoint': {'lat': 41.56448, 'lon': -87.51254}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Greater Baltimore Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Baystate Medical Center', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'New England Orthopedic Surgeons', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'St Francis Hospital', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Franciscan Neurosurgery Associates', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'Robert J Jackson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orange County Neurosurgical Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LDR Spine USA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}