Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:03 PM
Study NCT ID:
NCT01343693
Status:
COMPLETED
Last Update Posted:
2020-01-06
First Post:
2011-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MaxAn Post Market Surveillance Validation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'spinemedinfo@zimmerbiomet.com', 'phone': '303-501-8571', 'title': 'Zimmer Biomet Spine Clinical Affairs', 'organization': 'Zimmer Biomet Spine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 Months', 'description': 'All adverse events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study were recorded as part of the study.', 'eventGroups': [{'id': 'EG000', 'title': 'ACDF With MaxAn Plate', 'description': 'Any subject with DDD, tumor, deformity ot trauma to the cervical spine in which the investigator determines the subject will require an ACDF using the MaxAn Plate.', 'otherNumAtRisk': 119, 'deathsNumAtRisk': 119, 'otherNumAffected': 83, 'seriousNumAtRisk': 119, 'deathsNumAffected': 0, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Musculoskeletal Other - Pseudoarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Musculoskeletal other - Degenerative disc disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neck Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Paresthesia', 'notes': 'Upper extremity numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Radiculitis', 'notes': 'Cervical radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Arthralgia', 'notes': 'Shoulder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Procedural complication, other', 'notes': 'Subsidence of spine implant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Procedural complication other', 'notes': 'Migration of spine implant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Radiculitis', 'notes': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Musculoskeletal other', 'notes': 'Lumbar spondylosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Neck pain', 'notes': 'Subsequent surgery due to neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Differing Severity of Adjacent Level Ossification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACDF With MaxAn Plate', 'description': 'Any subject with DDD, tumor, deformity ot trauma to the cervical spine in which the investigator determines the subject will require an ACDF using the MaxAn Plate.'}], 'classes': [{'categories': [{'title': 'Grade 0', 'measurements': [{'value': '36', 'groupId': 'OG000'}]}, {'title': 'Grade 1', 'measurements': [{'value': '38', 'groupId': 'OG000'}]}, {'title': 'Grade 2', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Grade 3', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Unable to Assess', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Missing Radiographs', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 Months', 'description': 'Qualitatively assessed by an independent Radiologist using lateral radiographs Grade 0 - None Grade 1 - Mild (if the ossification extended across \\<50% of the disc space) Grade 2 - Moderate (if the ossification extended across ≥ 50% of the disc space) Grade 3 - Severe (if there is complete bridging of the adjacent disc space)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Ten of the 110 patients with 24 month follow up were not evaluated for this endpoint. Eight had missing radiographs and 2 had unevaluable radiographs.'}, {'type': 'SECONDARY', 'title': 'Change in Neck Disability Index (NDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACDF With MaxAn Plate', 'description': 'Any subject with DDD, tumor, deformity ot trauma to the cervical spine in which the investigator determines the subject will require an ACDF using the MaxAn Plate.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.0', 'spread': '20.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 Months', 'description': "The Neck Disability Index (NDI) is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain', with the points summed to a total score. The test can be interpretated as a raw score, with a minimum score of 0 and a maximum score of 50. A higher score indicates more patient-rated disability. To use the NDI for patient decisions, a clinically important change was calculated as 5 points.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ACDF With MaxAn Plate', 'description': 'Any subject with DDD, tumor, deformity ot trauma to the cervical spine in which the investigator determines the subject will require an ACDF using the MaxAn Plate.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ACDF With MaxAn Plate', 'description': 'Any subject with DDD, tumor, deformity ot trauma to the cervical spine in which the investigator determines the subject will require an ACDF using the MaxAn Plate.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '54.3', 'groupId': 'BG000', 'lowerLimit': '31.4', 'upperLimit': '81.1'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '66', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '119', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI (kg/m^2)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '29.8', 'spread': '5.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Employment Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Currently Working', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Disabled/Retired Due to Ill Health', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Retired', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Unemployed', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Workers Compensation', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Tobacco Use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Current', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'Past', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Never', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Cervical Spine Surgery', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '95', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'History of any previous spine surgery in the cervical region, included fusion, discectomy, decompression, laminectomy.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Operated Levels', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}]}], 'categories': [{'title': 'One vertebral level', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Two vertebral levels', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}, {'title': 'Three vertebral levels', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-02-02', 'size': 222660, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-06-17T12:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-17', 'studyFirstSubmitDate': '2011-04-27', 'resultsFirstSubmitDate': '2019-06-17', 'studyFirstSubmitQcDate': '2011-04-27', 'lastUpdatePostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-17', 'studyFirstPostDateStruct': {'date': '2011-04-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Differing Severity of Adjacent Level Ossification', 'timeFrame': '24 Months', 'description': 'Qualitatively assessed by an independent Radiologist using lateral radiographs Grade 0 - None Grade 1 - Mild (if the ossification extended across \\<50% of the disc space) Grade 2 - Moderate (if the ossification extended across ≥ 50% of the disc space) Grade 3 - Severe (if there is complete bridging of the adjacent disc space)'}], 'secondaryOutcomes': [{'measure': 'Change in Neck Disability Index (NDI)', 'timeFrame': '24 Months', 'description': "The Neck Disability Index (NDI) is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain', with the points summed to a total score. The test can be interpretated as a raw score, with a minimum score of 0 and a maximum score of 50. A higher score indicates more patient-rated disability. To use the NDI for patient decisions, a clinically important change was calculated as 5 points."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DDD', 'Deformity', 'Tumor', 'Fracture', 'Cervical'], 'conditions': ['DDD', 'Deformity', 'Tumor', 'Fracture']}, 'descriptionModule': {'briefSummary': 'This study is being performed to document the outcomes of subjects using our MaxAn Anterior Cervical Plate and assess them for Adjacent level Disease. All subjects will be followed for 2 years.', 'detailedDescription': 'The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the MaxAn® Anterior Cervical Plate System. Dr. Park, et.al conducted a retrospective review and found a positive association between adjacent-level ossification following anterior cervical plate procedures and the plate-to-disc distance. 1 They concluded that when the anterior cervical plates were placed at least 5mm away from the adjacent disc spaces, there was a decrease in the likelihood of moderate-to-severe adjacent-level ossification. The design of the MaxAn Anterior Cervical Plate and accompanying technique allows this type of plate placement; therefore we will be looking at the radiographic outcomes of these subjects and comparing them to the retrospective chart review conducted by Dr. Park using the MaxAn Technique allows you to achieve plate placement of 5mm from the supraadjacent level which will help minimize the risk of adjacent level ossification.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This post market surveillance study will enroll two hundred (200) subjects across 10 clinical centers within the United States with subjects followed for 24 months post-surgery. All subjects enrolled in the study will be recruited from the pool of subjects presenting to each investigational site for an anterior cervical fusion procedure. The 10 surgeons chosen to participate in this study will be thoroughly knowledgeable in the medical, surgical and mechanical aspects of the MaxAn® Anterior Cervical Plate System. The following inclusion and exclusion criteria must be met for a patient to be considered eligible for participation in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is scheduled to undergo a one to three-level primary spinal fusion surgery between the levels of C2-T1 (Cervical 2 to Thoracic 1) using the MaxAn® Anterior Cervical Plate System.\n* Subject has agreed to participate in this study, sign the informed consent and have agreed to return for the 6, 12 and 24 month follow-up visits.\n* Subjects or their representative must be willing and able to give informed consent.\n\nExclusion Criteria:\n\n* Subject has spinal infection or inflammation at any level.\n* Subject is morbidly obese, defined as a BMI greater than 40.\n* Subject has a mental illness, alcoholism or drug abuse.\n* Subject has a metal sensitivity/foreign body sensitivity.\n* Subject has inadequate tissue coverage over the operative site.\n* Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, osteopenia and/or osteoporosis.\n* Female subjects who are pregnant or plan to become pregnant in the next 24 months or who are lactating.\n* Subject who does not meet the specific indications for use of the MaxAn® Anterior Cervical Plate System.\n* Subjects participating in another clinical research study.\n* Any previous cervical spinal surgery.'}, 'identificationModule': {'nctId': 'NCT01343693', 'acronym': 'MaxAn', 'briefTitle': 'MaxAn Post Market Surveillance Validation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'A Post Market Surveillance Validation to Evaluate the Effectiveness of the MaxAn Anterior Cervical Plate', 'orgStudyIdInfo': {'id': 'CS-059'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anterior cervical discectomy and fusion', 'description': 'Any subject with DDD, tumor, deformity ot trauma to the cervical spine in which the investigator determines the subject will require an ACDF using the MaxAn Plate.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '36116', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'Montgomery Spine Center', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Tallahassee Neurological Clinic', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '46219', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Community Neurosurgery', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21401', 'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'facility': 'Maryland Spine and Brain', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}, {'zip': '27518', 'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Cary Orthopedics', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'zip': '76107', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'DFW Center for Spinal Disorders', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'overallOfficials': [{'name': 'Gary Dix, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maryland Spine and Brain'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}