Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-29 @ 6:02 AM
Study NCT ID:
NCT01110967
Status:
COMPLETED
Last Update Posted:
2016-01-28
First Post:
2010-04-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Satellite™ PEEK Nucleus Replacement Retrospective Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}, {'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, '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 sole 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 7 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': 'Due to the retrospective design, it was not possible to report on SF-36 results and Modic endplate changes results as limited data was available in the patient records.'}}, 'adverseEventsModule': {'timeFrame': 'Patients were followed up according to the local practice, up to 1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Patients Implanted With a Satellite Device', 'otherNumAtRisk': 40, 'otherNumAffected': 6, 'seriousNumAtRisk': 40, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Residual Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Back pain and Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Low back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}], 'seriousEvents': [{'term': 'Residual Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Health-related Quality of Life Using the Visual Analogue Scale for Back Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Implanted With a Satellite Device'}], 'classes': [{'title': 'Back pain pre-operative (n = 32)', 'categories': [{'measurements': [{'value': '5.5', 'spread': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'Back pain at 1 month Follow up (n = 25)', 'categories': [{'measurements': [{'value': '2.6', 'spread': '2.2', 'groupId': 'OG000'}]}]}, {'title': 'Back pain at 3 months Follow up (n = 25)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Back pain at 6 months Follow up (n = 18)', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Back pain at 12 months Follow up (n = 26)', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 months follow up visit', 'description': "The Visual Analogue Scale (VAS) is a tool widely used to measure pain. It is a 10 cm scale, 0cm means 'no pain' and 10cm means 'worst possible pain'. The patients mark the location corresponding to the amount of back pain they experienced on the 10cm line.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Implanted With a Satellite Device'}], 'classes': [{'title': 'Leg pain pre-operative (n = 30)', 'categories': [{'measurements': [{'value': '7.2', 'spread': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'Leg pain at 1 month Follow up (n = 25)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Leg pain at 3 months Follow up (n = 25)', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Leg pain at 6 months Follow up (n = 18)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Leg pain at 12 months Follow up (n = 26)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 months follow up visit', 'description': "The Visual Analogue Scale (VAS) is a tool widely used to measure pain. It is a 10 cm scale, 0cm means 'no pain' and 10cm means 'worst possible pain'. The patients mark the location corresponding to the amount of back pain they experienced on the 10cm line.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Physical Functioning Using the Oswestry Disability Index (ODI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Implanted With a Satellite Device'}], 'classes': [{'title': 'ODI pre-operative (n = 38)', 'categories': [{'measurements': [{'value': '48.2', 'spread': '19.6', 'groupId': 'OG000'}]}]}, {'title': 'ODI at 1 month Follow up (n = 26)', 'categories': [{'measurements': [{'value': '23.2', 'spread': '16.0', 'groupId': 'OG000'}]}]}, {'title': 'ODI at 3 months Follow up (n = 30)', 'categories': [{'measurements': [{'value': '18.6', 'spread': '12.4', 'groupId': 'OG000'}]}]}, {'title': 'ODI at 6 months Follow up (n = 23)', 'categories': [{'measurements': [{'value': '17.5', 'spread': '13.0', 'groupId': 'OG000'}]}]}, {'title': 'ODI at 12 months Follow up (n = 29)', 'categories': [{'measurements': [{'value': '11.4', 'spread': '9.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 months follow up visit', '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 50; 0 meaning 'no disability' and 50 meaning 'maximum disability'.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Range of Motion (ROM) at Implanted Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Implanted With a Satellite Device'}], 'classes': [{'title': 'ROM pre-operative (n = 22)', 'categories': [{'measurements': [{'value': '10.0', 'spread': '7.9', 'groupId': 'OG000'}]}]}, {'title': 'ROM at 3 month Follow up (n = 20)', 'categories': [{'measurements': [{'value': '14.3', 'spread': '5.8', 'groupId': 'OG000'}]}]}, {'title': 'ROM at 6 month Follow up (n = 16)', 'categories': [{'measurements': [{'value': '12.1', 'spread': '9.8', 'groupId': 'OG000'}]}]}, {'title': 'ROM at 12 month Follow up (n = 16)', 'categories': [{'measurements': [{'value': '14.9', 'spread': '6.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 months follow up visit', 'description': 'The range of motion (ROM) was calculated as the angle of the segment on the flexion radiograph minus the angle of the segment on the extension radiograph, expressed in degrees (absolute value).', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intervertebral Disc Space (IVD) at Implanted Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Implanted With a Satellite Device'}], 'classes': [{'title': 'IVD pre-operative (n = 35)', 'categories': [{'measurements': [{'value': '0.30', 'spread': '0.08', 'groupId': 'OG000'}]}]}, {'title': 'IVD post-operative (n = 29)', 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.07', 'groupId': 'OG000'}]}]}, {'title': 'IVD at 3 months Follow up (n = 21)', 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.07', 'groupId': 'OG000'}]}]}, {'title': 'IVD at 6 months Follow up (n = 18)', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.06', 'groupId': 'OG000'}]}]}, {'title': 'IVD at 12 months Follow up (n = 19)', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.06', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 months follow up visit', 'description': 'The Intervertebral Disc Space (IVD) was measured as average disc height, calculated as \\[(A+B)/2\\]/H, where A is the posterior intervertebral disc height, B is the anterior intervertebral disc height and H is the anterior height of upper vertebral body.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Device Subsidence Measured as Interbody Height Ratio (IBHR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Implanted With a Satellite Device'}], 'classes': [{'title': 'IBHR at surgery (n = 34)', 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'IBHR at 3 months Follow up (n = 20)', 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'IBHR at 6 months Follow up (n = 18)', 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'IBHR at 12 months Follow up (n = 21)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 months follow up visit', 'description': 'Interbody Height Ratio (IBHR) is calculated as the total vertical height of the two vertebral bodies directly superior and inferior to the implant divided by the anteroposterior diameter of the superior vertebral body.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Device Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Implanted With a Satellite Device'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months follow up visit', 'unitOfMeasure': 'participant', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Safety by Evaluating the Number of Serious Adverse Device Effects (SADEs), Adverse Device Effects (ADEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Implanted With a Satellite Device'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Patients were followed up according to the local practice, up to 1 year', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients Implanted With a Satellite Device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'Surgery', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': '1 Month Follow up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': '3 Months Follow up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': '6 Months Follow up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': '12 Months Follow up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients Implanted With a Satellite Device'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41', 'spread': '11.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Venezuela', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-26', 'studyFirstSubmitDate': '2010-04-15', 'resultsFirstSubmitDate': '2014-05-13', 'studyFirstSubmitQcDate': '2010-04-23', 'lastUpdatePostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-14', 'studyFirstPostDateStruct': {'date': '2010-04-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health-related Quality of Life Using the Visual Analogue Scale for Back Pain', 'timeFrame': 'Up to 12 months follow up visit', 'description': "The Visual Analogue Scale (VAS) is a tool widely used to measure pain. It is a 10 cm scale, 0cm means 'no pain' and 10cm means 'worst possible pain'. The patients mark the location corresponding to the amount of back pain they experienced on the 10cm line."}, {'measure': 'Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain', 'timeFrame': 'Up to 12 months follow up visit', 'description': "The Visual Analogue Scale (VAS) is a tool widely used to measure pain. It is a 10 cm scale, 0cm means 'no pain' and 10cm means 'worst possible pain'. The patients mark the location corresponding to the amount of back pain they experienced on the 10cm line."}, {'measure': 'Physical Functioning Using the Oswestry Disability Index (ODI)', 'timeFrame': 'Up to 12 months follow up visit', '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 50; 0 meaning 'no disability' and 50 meaning 'maximum disability'."}, {'measure': 'Safety by Evaluating the Number of Serious Adverse Device Effects (SADEs), Adverse Device Effects (ADEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Patients were followed up according to the local practice, up to 1 year'}], 'secondaryOutcomes': [{'measure': 'Range of Motion (ROM) at Implanted Level', 'timeFrame': 'Up to 12 months follow up visit', 'description': 'The range of motion (ROM) was calculated as the angle of the segment on the flexion radiograph minus the angle of the segment on the extension radiograph, expressed in degrees (absolute value).'}, {'measure': 'Intervertebral Disc Space (IVD) at Implanted Level', 'timeFrame': 'Up to 12 months follow up visit', 'description': 'The Intervertebral Disc Space (IVD) was measured as average disc height, calculated as \\[(A+B)/2\\]/H, where A is the posterior intervertebral disc height, B is the anterior intervertebral disc height and H is the anterior height of upper vertebral body.'}, {'measure': 'Device Subsidence Measured as Interbody Height Ratio (IBHR)', 'timeFrame': 'Up to 12 months follow up visit', 'description': 'Interbody Height Ratio (IBHR) is calculated as the total vertical height of the two vertebral bodies directly superior and inferior to the implant divided by the anteroposterior diameter of the superior vertebral body.'}, {'measure': 'Changes in Device Placement', 'timeFrame': 'Up to 12 months follow up visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Degenerative Disc Disease, Lumbar', 'Disc Herniation, Lumbar']}, 'descriptionModule': {'briefSummary': 'The Satellite™ Retrospective Analysis is an international, retrospective, multi-center, non-interventional post-marketing study designed to document and analyze existing data with the device in a "real-world" setting.\n\nThe purpose of this study is to evaluate number of adverse device effects (ADEs), serious adverse device effects (SADEs) and serious adverse event (SAEs) and early clinical effectiveness for the Satellite™ Nucleus Replacement in a standard clinical practice. Data collection will include information on health related quality of life (QoL), physical functioning and adverse event after nucleus replacement surgery. Radiographic measures will also be assessed to evaluate changes in disc height at the operated level and changes in segmental range of motion.\n\nAll patients who were implanted with a Satellite™ Nucleus Replacement Prosthesis in the participating sites are eligible for participation in the Satellite ™ Retrospective Analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who were implanted with a Satellite™ Nucleus Replacement device at the participating sites are eligible for participation in the Satellite ™ Retrospective Analysis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient must have signed a Patient Data Release Form\n* Age of at least 18 years and skeletally mature at the time of surgery\n\nExclusion Criterion:\n\n* Patient has not reached the age of legal consent according to local laws'}, 'identificationModule': {'nctId': 'NCT01110967', 'briefTitle': 'Satellite™ PEEK Nucleus Replacement Retrospective Analysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Spinal and Biologics'}, 'officialTitle': 'Satellite™ PEEK Nucleus Replacement Retrospective Analysis', 'orgStudyIdInfo': {'id': 'Satellite Retrospective'}}, 'contactsLocationsModule': {'locations': [{'city': 'Ústí nad Labem', 'country': 'Czechia', 'facility': 'Masaryk Hospital', 'geoPoint': {'lat': 50.6607, 'lon': 14.03227}}, {'city': 'Ružomberok', 'country': 'Slovakia', 'facility': 'ÚVN SNP', 'geoPoint': {'lat': 49.0748, 'lon': 19.30751}}, {'city': 'Caracas', 'country': 'Venezuela', 'facility': 'Instituto de Columna de Caracas', 'geoPoint': {'lat': 10.48801, 'lon': -66.87919}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Spinal and Biologics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}