Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 11:59 PM
Study NCT ID:
NCT01338493
Status:
COMPLETED
Last Update Posted:
2016-01-28
First Post:
2011-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Maverick Total Disc Replacement in a 'Real World' Patient Population
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': 'cristina.faria@medtronic.com', 'phone': '+41 (0)21 802 70 00', 'title': 'Cristina Faria', 'organization': 'Medtronic Spinal & Biologics'}, 'certainAgreement': {'otherDetails': 'Confidential Information shall not be disclosed and shall be property of sponsor during the term of the agreement and for 3 years after agreement termination. Results might be published or presented, however sponsor should receive publication for review at least 90 days prior to submittal. Sponsor shall limit its review to a determination of whether Confidential Information is disclosed, to allow sponsor to protect its rights in copyrightable material, and to check for technical correctness.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Seriousness of AEs was not assessed when the data were collected so it is not possible to separate SAEs and Other (Non-serious) AEs for the Maverick Registry. All events are here-reported as SAEs.'}}, 'adverseEventsModule': {'timeFrame': '24 months', 'description': 'Seriousness of AEs was not assessed when the data were collected so it is not possible to separate SAEs and Other (Non-serious) AEs for the Maverick Registry. The study is now closed and it would not be possible to go back to the sites to ask them to classify the AEs. All events are here-reported as SAEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Lumbar Spinal Arthroplasty + Maverick™', 'description': 'Patients requiring total disc replacement\n\nlumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc.', 'otherNumAtRisk': 134, 'otherNumAffected': 0, 'seriousNumAtRisk': 134, 'seriousNumAffected': 57}], 'seriousEvents': [{'term': 'Abdominal wall related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders'}, {'term': 'Neurologic - Access-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Nervous system disorders'}, {'term': 'Neurologic - Late radiculopathy (not access-related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Nervous system disorders'}, {'term': 'Vascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders'}, {'term': 'Visceral - Bowel or Peritoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Visceral - Genito-Urinary tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders'}, {'term': 'Subsidence / Impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Early non-specific low BP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders'}, {'term': 'Late non-specific low BP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders'}, {'term': 'Foreign body reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders'}, {'term': 'Other events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 27, 'numAffected': 24}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reduction of Disability at 6 Months Versus Baseline Using the Oswestry Disability Index (ODI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lumbar Spinal Arthroplasty + Maverick™', 'description': 'Patients requiring total disc replacement\n\nlumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc.'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.4', 'groupId': 'OG000', 'lowerLimit': '-29.0', 'upperLimit': '-21.9'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': "The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 100; 0 meaning 'no disability' and 100 meaning 'maximum disability'.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Reduction of disability was calculated for patients having available data at both baseline and 6 months.'}, {'type': 'SECONDARY', 'title': 'Relief of Back Pain at 6 Months Versus Baseline Using the Back Pain Intensity Score Assessed on a 10 cm Visual Analogue Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lumbar Spinal Arthroplasty + Maverick™', 'description': 'Patients requiring total disc replacement\n\nlumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.0', 'groupId': 'OG000', 'lowerLimit': '-4.5', 'upperLimit': '-3.4'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Back Pain was documented in a Visual Analogue Scale where the patients marked the location on the 10-centimeter line corresponding to the amount of pain they experienced.\n\n0 = no pain, 10 = worst possible pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Reduction of disability was calculated for patients having available data at both baseline and 6 months.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lumbar Spinal Arthroplasty + Maverick™', 'description': 'Patients requiring total disc replacement\n\nlumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc.'}], 'periods': [{'title': 'Enrolled', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '139'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Patient not implanted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}, {'title': 'Implant', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Discharge', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Missed visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': '6 Months Follow up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Missed visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}]}, {'title': '12 Months Follow up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}, {'title': '24 Months Follow up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lumbar Spinal Arthroplasty + Maverick™', 'description': 'Patients requiring total disc replacement\n\nlumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43', 'spread': '9.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '70', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-26', 'studyFirstSubmitDate': '2011-02-17', 'resultsFirstSubmitDate': '2014-08-06', 'studyFirstSubmitQcDate': '2011-04-18', 'lastUpdatePostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-17', 'studyFirstPostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of Disability at 6 Months Versus Baseline Using the Oswestry Disability Index (ODI)', 'timeFrame': '6 months', 'description': "The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 100; 0 meaning 'no disability' and 100 meaning 'maximum disability'."}], 'secondaryOutcomes': [{'measure': 'Relief of Back Pain at 6 Months Versus Baseline Using the Back Pain Intensity Score Assessed on a 10 cm Visual Analogue Scale (VAS)', 'timeFrame': '6 months', 'description': 'Back Pain was documented in a Visual Analogue Scale where the patients marked the location on the 10-centimeter line corresponding to the amount of pain they experienced.\n\n0 = no pain, 10 = worst possible pain'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Degenerative Disc Disease']}, 'descriptionModule': {'briefSummary': "The primary purpose of the study is to document the reduction of disability after Maverick total disc replacement surgery in a 'real-world' patient population requiring disc replacement."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient eligibility is determined according to labeling', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Degenerative Disc Disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies\n* Foraminal stenosis due to loss of disc height\n* Back pain and/or leg pain.\n\nExclusion criteria:\n\n* Spondylolisthesis at the affected or adjacent level\n* Posterior facet joint damage and/or disease at the affected level, including facet osteoarthritis, pars fracture and prior laminectomy\n* Obesity\n* Osteoporosis\n* Metallic allergy to cobalt-chromium-molybdenum alloys\n* Psychosis\n* Infection\n* Spinal canal stenosis\n* Overlying thoracolumbar kyphosis\n* Systemic infection or infection at the site of surgery\n* Osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated\n* Diseases of bone metabolism\n* Pregnancy\n* Signs of local inflammation\n* Fever or Leukocytosis\n* Grossly distorted anatomy caused by congenital abnormalities\n* Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence of congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count (this also includes: spinal active oncology pathology; not healed fracture at treated or adjacent level)\n* Any case where the implants or components selected would be too large or too small to achieve a successful result\n* Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance\n* Any patient unwilling to follow postoperative instructions.'}, 'identificationModule': {'nctId': 'NCT01338493', 'acronym': 'Maverick', 'briefTitle': "Maverick Total Disc Replacement in a 'Real World' Patient Population", 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Spinal and Biologics'}, 'officialTitle': "Maverick Total Disc Replacement in a 'Real World' Patient Population - A Prospective, Multicenter, Observational Study", 'orgStudyIdInfo': {'id': 'Maverick Global Registry'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'lumbar spinal arthroplasty + Maverick™', 'description': 'Patients requiring total disc replacement', 'interventionNames': ['Procedure: lumbar spinal arthroplasty + Maverick™']}], 'interventions': [{'name': 'lumbar spinal arthroplasty + Maverick™', 'type': 'PROCEDURE', 'description': 'All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc.', 'armGroupLabels': ['lumbar spinal arthroplasty + Maverick™']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3G1A4', 'city': 'Québec', 'country': 'Canada', 'facility': 'Montreal General Hospital', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU Pellegrin Tripode', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '92141', 'city': 'Clamart', 'country': 'France', 'facility': 'CH Antoine Béclère - Service de Chirurgie Orthopédique', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': '92110', 'city': 'Clichy', 'country': 'France', 'facility': 'Service de Chirurgie Orthopédique, AP-HP, Hôpital Beaujon', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Clinique de Neurochirurgie Hôpital Roger Salengro', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'CH La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '78250', 'city': 'Meulan-en-Yvelines', 'country': 'France', 'facility': 'CH de Meulan - Service de Chirurgie Orthopédique', 'geoPoint': {'lat': 49.00768, 'lon': 1.90602}}, {'zip': '06300', 'city': 'Nice', 'country': 'France', 'facility': 'Service de Neurochirurgie Hôpital Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'CH Lariboisière, Service de Neurochirurgie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31300', 'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique du Cours Dillon', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Berlin - Klinik für Orthopädie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '39120', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Magdeburg', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '14482', 'city': 'Potsdam', 'country': 'Germany', 'facility': 'Praxis für Orthopädie und Neurochirurgie Potsdam', 'geoPoint': {'lat': 52.39886, 'lon': 13.06566}}], 'overallOfficials': [{'name': 'Jean-Charles Le Huec, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Pellegrin Tripode'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Spinal and Biologics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}