Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-03-01 @ 2:43 PM
Study NCT ID:
NCT01832818
Status:
TERMINATED
Last Update Posted:
2019-02-15
First Post:
2013-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post-Market Study Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rwaite@rtix.com', 'phone': '386-418-8888', 'title': 'Robin Waite', 'organization': 'RTI Surgical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were recorded over the 24 month follow-up period', 'eventGroups': [{'id': 'EG000', 'title': 'NuNec Cervical Disc', 'description': 'Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months.\n\nNuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 3, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'neurological impairment', 'notes': '1 patient developed a neurological impairment, this was not considered related to the surgery or the device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'notes': 'Ongoing Dysphagia (mainly to solids), hoarse voice ( improving)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in L forearm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hand Paranesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperesthesia', 'notes': 'Hyperesthesia C5/6 distribution L arm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Limited shoulder movement', 'notes': 'Limited movement L shoulder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Neck Disability Index (NDI) Score Improvement of at Least 15 Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NuNec Cervical Disc', 'description': 'Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months.\n\nNuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.4', 'spread': '27.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'At 24 months', 'description': 'The Neck Disability Index is a patient reported outcome measure for self-rated disability due to neck pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. A higher score would indicate that the patient did not improve.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Visual Analog Scale (VAS) Improvement of 2.0 cm for Neck Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NuNec Cervical Disc', 'description': 'Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months.\n\nNuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.97', 'spread': '3.27', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '< 0.05', 'groupIds': ['OG000'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'At 24 months', 'description': 'The pain Visual Analog Scale is a uni-dimensional measure of pain intensity, represented by a 100 mm line, anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \\[100-mm scale\\]). A higher score would indicate that the patient had a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Serious Adverse Events Related to the Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NuNec Cervical Disc', 'description': 'Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months.\n\nNuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 months', 'description': 'The number of serious adverse events have been recorded', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Device Failures or Removals, Revisions, Re-operations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NuNec Cervical Disc', 'description': 'Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months.\n\nNuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 months', 'description': 'The failures or re-operations or supplemental fixation at the treated level', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NuNec Cervical Disc', 'description': 'Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months.\n\nNuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.'}], 'classes': [{'categories': [{'title': 'Very Satisfied', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Satisfied', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Somewhat Satisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Unsatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 24 months', 'description': 'As assessed on patient questionnaire.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Absence of Device Migration or Subsidence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NuNec Cervical Disc', 'description': 'Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months.\n\nNuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 months', 'description': 'Absence of device migration \\> 3mm; Absence of device subsidence \\> 3mm', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NuNec Cervical Disc', 'description': 'Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months.\n\nNuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'NuNec Cervical Disc', 'description': 'Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months.\n\nNuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44', 'spread': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'This study has been terminated early due to slow enrolment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-01', 'studyFirstSubmitDate': '2013-04-10', 'resultsFirstSubmitDate': '2018-02-05', 'studyFirstSubmitQcDate': '2013-04-15', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-01', 'studyFirstPostDateStruct': {'date': '2013-04-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neck Disability Index (NDI) Score Improvement of at Least 15 Points', 'timeFrame': 'At 24 months', 'description': 'The Neck Disability Index is a patient reported outcome measure for self-rated disability due to neck pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. A higher score would indicate that the patient did not improve.'}, {'measure': 'Visual Analog Scale (VAS) Improvement of 2.0 cm for Neck Pain', 'timeFrame': 'At 24 months', 'description': 'The pain Visual Analog Scale is a uni-dimensional measure of pain intensity, represented by a 100 mm line, anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \\[100-mm scale\\]). A higher score would indicate that the patient had a worse outcome.'}, {'measure': 'Serious Adverse Events Related to the Device', 'timeFrame': 'Up to 24 months', 'description': 'The number of serious adverse events have been recorded'}, {'measure': 'Device Failures or Removals, Revisions, Re-operations', 'timeFrame': 'Up to 24 months', 'description': 'The failures or re-operations or supplemental fixation at the treated level'}], 'secondaryOutcomes': [{'measure': 'Patient Satisfaction', 'timeFrame': 'At 24 months', 'description': 'As assessed on patient questionnaire.'}, {'measure': 'Absence of Device Migration or Subsidence', 'timeFrame': 'Up to 24 months', 'description': 'Absence of device migration \\> 3mm; Absence of device subsidence \\> 3mm'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Total Disc Replacement'], 'conditions': ['Cervical Intervertebral Disc Degeneration']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate long-term safety and effectiveness of the NuNec® Cervical Arthroplasty System in a small patient population. The NuNec device is currently CE marked and commercially available in Europe.', 'detailedDescription': 'The NuNec® feasibility study is a prospective, multi-centered, non-randomized clinical trial. Only patients who have been diagnosed with single level, C3 to C7, symptomatic cervical degenerative disc disease and have failed at least 6 weeks of conservative treatment or present signs of progression of spinal cord/nerve root compression with continued non-operative care will be enrolled.\n\nPatients will be evaluated preoperatively and postoperatively at discharge, 6 weeks, 3, 6, 12 and 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* is at least 21 years of age and skeletally mature\n* must have symptomatic degenerative disc disease at one level in the cervical spine, C3 to C7, demonstrated by herniated disc and/or spondylosis;\n* must have completed a minimum of six weeks of unsuccessful conservative, non-operative care or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment\n* must score at least 15/50 (30%) on the Neck Disability Index\n* is willing and able to follow the post-operative management program\n* must understand and sign the informed consent document\n\nExclusion Criteria:\n\n* symptomatic cervical DDD at more than one level\n* axial neck pain as the primary diagnosis without evidence of neural compression\n* neck or arm pain of unknown etiology\n* any significant anatomical consideration which would make the anterior cervical approach excessively risky or impossible\n* severe spondylosis at the target level\n* prior surgery at the target level\n* fused level adjacent to the target level\n* osteoporosis, osteopenia, osteomalacia, Paget's disease or metabolic bone disease\n* active infection or surgical site infection\n* is using any medication known to interfere with bone/soft tissue healing\n* diabetes mellitus requiring daily insulin management\n* any terminal, systemic, or autoimmune disease\n* medical conditions or mental incompetence which may interfere with study requirements\n* BMI \\>40 or a weight more than 100 lbs over ideal body weight\n* chemical dependency problem that may interfere with study requirements\n* current smokers\n* history of any invasive malignancy unless treated and in remission for at least two years\n* documented allergies to metal or plastic\n* currently pregnant, or interested in becoming pregnant during the study follow-up"}, 'identificationModule': {'nctId': 'NCT01832818', 'briefTitle': 'Post-Market Study Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pioneer Surgical Technology, Inc.'}, 'officialTitle': 'A Prospective, Feasibility, Multi-Center Nonrandomized Clinical Trial Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System', 'orgStudyIdInfo': {'id': 'C01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NuNec Cervical Disc', 'description': 'Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months.', 'interventionNames': ['Device: NuNec Cervical Disc']}], 'interventions': [{'name': 'NuNec Cervical Disc', 'type': 'DEVICE', 'otherNames': ['NuNec Cervical Arthroplasty System'], 'description': 'Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.', 'armGroupLabels': ['NuNec Cervical Disc']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockton-on-Tees', 'country': 'United Kingdom', 'facility': 'University Hospital of North Tees', 'geoPoint': {'lat': 54.56848, 'lon': -1.3187}}], 'overallOfficials': [{'name': 'Tai Friesem, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of North Tees'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pioneer Surgical Technology, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}