Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
Study NCT ID:
NCT00637156
Status:
COMPLETED
Last Update Posted:
2018-05-01
First Post:
2008-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011843', 'term': 'Radiculopathy'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059145', 'term': 'Total Disc Replacement'}, {'id': 'D001860', 'term': 'Bone Plates'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D016268', 'term': 'Internal Fixators'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D009984', 'term': 'Orthopedic Fixation Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'msbkclinicalresearch@medtronic.com', 'phone': '1800-876-3133', 'title': 'Clinical Department', 'phoneExt': '6068', 'organization': 'Medtronic Spine and biologics'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'up to 24 months', 'eventGroups': [{'id': 'EG000', 'title': 'PRESTIGE LP Device', 'description': 'PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.', 'otherNumAtRisk': 209, 'otherNumAffected': 191, 'seriousNumAtRisk': 209, 'seriousNumAffected': 72}, {'id': 'EG001', 'title': 'ATLANTIS Cervical Plate System', 'description': 'Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.', 'otherNumAtRisk': 188, 'otherNumAffected': 171, 'seriousNumAtRisk': 188, 'seriousNumAffected': 90}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Congenital choroid plexus cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders'}, {'term': 'Spine malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Eustachian tube dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': "Meniere's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Adrenal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders'}, {'term': 'Blepharospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Conjunctival discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Eye swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Eyelid ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Papilloedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Scintillating scotoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Acquired oesophageal web', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Functional gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastric polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastrointestinal sounds abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Intestinal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Loose tooth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Salivary gland mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Tooth erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Complication of device insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Device connection issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Device deployment issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Gait disturbance', 'stats': 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188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Uterine enlargement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Lung infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Nasal septum deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Nasal septum perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pleural fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Respiratory depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Telangiectasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Tobacco user', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances'}, {'term': 'Bunion operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Carpal tunnel decompression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Gastric banding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Hysterectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Peripheral nerve decompression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Prolapse repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Rotator cuff repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Skin graft', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Spinal decompression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Spinal fusion surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Vascular stent insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders'}, {'term': 'Femoral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '0.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Overall Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRESTIGE LP Device', 'description': 'PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.'}, {'id': 'OG001', 'title': 'ATLANTIS Cervical Plate System', 'description': 'Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.4', 'groupId': 'OG000'}, {'value': '69.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.113', 'ciLowerLimit': '0.022', 'ciUpperLimit': '0.201', 'pValueComment': 'The posterior probability of non-inferiority was calculated and presented instead of the p-value.', 'estimateComment': 'The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.', 'groupDescription': 'The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \\> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P(p1 - p0 \\> -d \\| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.', 'statisticalMethod': 'Bayesian model', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The non-inferiority margin is 0.1.'}, {'pValue': '0.993', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The posterior probability of superiority was calculated and presented instead of the p-value.', 'groupDescription': 'Superiority comparison of overall success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated. If the posterior probability is at least 0.95, a claim of superiority can be made.', 'statisticalMethod': 'Bayesian model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '24 Months', 'description': 'Rate of overall success is reported as the percentage of participants who met all of the following criteria:\n\n1. Postoperative Neck Disability Index (NDI) score improvement of at least a 15-point increase from preoperative;\n2. Maintenance or improvement in neurological status;\n3. No serious adverse event classified as implant associated or implant/surgical procedure associated; and\n4. No additional surgical procedure classified as a "failure."', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis dataset for this study included all subjects who received study devices and completed the initial surgical procedures. The analysis was based on the observed data and missing data due to lost-to-follow-ups were imputed. For the primary endpoint, the analysis consists of 199 investigational subjects and 160 control subjects.'}, {'type': 'SECONDARY', 'title': 'Success Rate of Neck Disability Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRESTIGE LP Device', 'description': 'PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.'}, {'id': 'OG001', 'title': 'ATLANTIS Cervical Plate System', 'description': 'Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.9', 'groupId': 'OG000'}, {'value': '79.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.088', 'ciLowerLimit': '0.012', 'ciUpperLimit': '0.167', 'pValueComment': 'The posterior probability of non-inferiority was calculated and presented instead of the p-value.', 'estimateComment': 'The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.', 'groupDescription': 'The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \\> p0 where P0 and P1 are the NDI success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \\> -d \\| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.', 'statisticalMethod': 'Bayesian model', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority margin is 0.1.'}, {'pValue': '0.990', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The posterior probability of superiority was calculated and presented instead of the p-value.', 'groupDescription': 'Superiority comparison of NDI success rates in two treatment groups was performed if non-inferiority was demonstrated.', 'statisticalMethod': 'Bayesian model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met the following criterion: Pre-treatment Score - Post-treatment Score ≥ 15.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable NDI success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.'}, {'type': 'SECONDARY', 'title': 'Success Rate of Neurological Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRESTIGE LP Device', 'description': 'PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.'}, {'id': 'OG001', 'title': 'ATLANTIS Cervical Plate System', 'description': 'Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.5', 'groupId': 'OG000'}, {'value': '86.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.014', 'ciUpperLimit': '0.119', 'pValueComment': 'The posterior probability of non-inferiority was calculated and presented instead of the p-value.', 'estimateComment': 'The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.', 'groupDescription': 'The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \\> p0 where P0 and P1 are the neurological success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \\> -d \\| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.', 'statisticalMethod': 'Bayesian model', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority margin is 0.1.'}, {'pValue': '0.931', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The posterior probability of superiority was calculated and presented instead of the p-value.', 'groupDescription': 'Superiority comparison of neurological success rates in two treatment groups was performed if non-inferiority was demonstrated.', 'statisticalMethod': 'Bayesian model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must either remain the same or improve from the time of the preoperative evaluation to the time period evaluated.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neurological success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.'}, {'type': 'SECONDARY', 'title': 'Neck Pain Success Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRESTIGE LP Device', 'description': 'PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.'}, {'id': 'OG001', 'title': 'ATLANTIS Cervical Plate System', 'description': 'Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.0', 'groupId': 'OG000'}, {'value': '95.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.021', 'ciLowerLimit': '-0.019', 'ciUpperLimit': '0.062', 'pValueComment': 'The posterior probability of non-inferiority was calculated and presented instead of the p-value.', 'estimateComment': 'The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.', 'groupDescription': 'The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \\> p0 where P0 and P1 are the neck pain success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \\> -d \\| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.', 'statisticalMethod': 'Bayesian model', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority margin is 0.1.'}, {'pValue': '0.852', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The posterior probability of superiority was calculated and presented instead of the p-value.', 'groupDescription': 'Superiority comparison of neck pain success rates in two treatment groups was performed if non-inferiority was demonstrated.', 'statisticalMethod': 'Bayesian model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and frequency scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Neck pain success rate is reported as the percentage of participants whose neck pain improvement met the following criterion: Preoperative Score - Postoperative Score \\> 0.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neck pain success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.'}, {'type': 'SECONDARY', 'title': 'Arm Pain Success Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRESTIGE LP Device', 'description': 'PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.'}, {'id': 'OG001', 'title': 'ATLANTIS Cervical Plate System', 'description': 'Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000'}, {'value': '89.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.997', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.008', 'ciLowerLimit': '-0.073', 'ciUpperLimit': '0.056', 'pValueComment': 'The posterior probability of non-inferiority was calculated and presented instead of the p-value.', 'estimateComment': 'The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.', 'groupDescription': 'The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \\> p0 where P0 and P1 are the arm pain success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \\> -d \\| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.', 'statisticalMethod': 'Bayesian model', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority margin is 0.1.'}, {'pValue': '0.395', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The posterior probability of superiority was calculated and presented instead of the p-value.', 'groupDescription': 'Superiority comparison of arm pain success rates in two treatment groups was performed if non-inferiority was demonstrated.', 'statisticalMethod': 'Bayesian model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and frequency scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Arm pain success rate is reported as the percentage of participants whose arm pain improvement met the following criterion: Preoperative Score - Postoperative Score \\> 0.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable arm pain success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.'}, {'type': 'SECONDARY', 'title': 'Success Rate of SF-36 PCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRESTIGE LP Device', 'description': 'PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.'}, {'id': 'OG001', 'title': 'ATLANTIS Cervical Plate System', 'description': 'Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.4', 'groupId': 'OG000'}, {'value': '87.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.024', 'ciLowerLimit': '-0.042', 'ciUpperLimit': '0.088', 'pValueComment': 'The posterior probability of non-inferiority was calculated and presented instead of the p-value.', 'estimateComment': 'The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.', 'groupDescription': 'The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \\> p0 where P0 and P1 are the SF-36 PCS success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \\> -d \\| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.', 'statisticalMethod': 'Bayesian model', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority margin is 0.1.'}, {'pValue': '0.767', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The posterior probability of superiority was calculated and presented instead of the p-value.', 'groupDescription': 'Superiority comparison of SF-36 PCS success rates in two treatment groups was performed if non-inferiority was demonstrated.', 'statisticalMethod': 'Bayesian model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 PCS was defined as: Post Score - Pre Score \\>= 0. The Success rate of SF-36 PCS is reported as the percentage of the participants who were classified as a success for SF-36 PCS.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 PCS success status at 24 months, which leads to 197 subjects in the investigational group and 156 subjects in the control group.'}, {'type': 'SECONDARY', 'title': 'Success Rate of SF-36 MCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRESTIGE LP Device', 'description': 'PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.'}, {'id': 'OG001', 'title': 'ATLANTIS Cervical Plate System', 'description': 'Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000'}, {'value': '72.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.945', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.024', 'ciLowerLimit': '-0.120', 'ciUpperLimit': '0.067', 'pValueComment': 'The posterior probability of non-inferiority was calculated and presented instead of the p-value.', 'estimateComment': 'The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.', 'groupDescription': 'The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \\> p0 where P0 and P1 are the SF-36 MCS success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \\> -d \\| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.', 'statisticalMethod': 'Bayesian model', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority margin is 0.1.'}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 MCS were defined as: Post Score - Pre Score \\>= 0. The Success rate of SF-36 MCS is reported as the percentage of the participants who were classified as a success for SF-36 MCS.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 MCS success status at 24 months, which leads to 197 subjects in the investigational group and 156 subjects in the control group.'}, {'type': 'SECONDARY', 'title': 'Rate of Disc Height Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRESTIGE LP Device', 'description': 'PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.'}, {'id': 'OG001', 'title': 'ATLANTIS Cervical Plate System', 'description': 'Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.5', 'groupId': 'OG000'}, {'value': '95.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.997', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.017', 'ciLowerLimit': '-0.072', 'ciUpperLimit': '0.040', 'pValueComment': 'The posterior probability of non-inferiority was calculated and presented instead of the p-value.', 'estimateComment': 'The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.', 'groupDescription': 'The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \\> p0 where P0 and P1 are the FSU success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \\> -d \\| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.', 'statisticalMethod': 'Bayesian model', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority margin is 0.1.'}, {'pValue': '0.271', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The posterior probability of superiority was calculated and presented instead of the p-value.', 'groupDescription': 'Superiority comparison of FSU success rates in two treatment groups was performed if non-inferiority was demonstrated.', 'statisticalMethod': 'Bayesian model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Disc height was assessed by determining the Functional Spinal Unit (FSU) height. The rate of disc height success is reported as the percentage of participants whose disc height for each level based on either the anterior or posterior measurements met the following criterion: Postoperative Height - 6 Week Postoperative Height \\>= -2mm', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable disc height success (FSU success) status at 24 months, which leads to 170 subjects in the investigational group and 138 subjects in the control group.'}, {'type': 'SECONDARY', 'title': 'Gait Success Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRESTIGE LP Device', 'description': 'PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.'}, {'id': 'OG001', 'title': 'ATLANTIS Cervical Plate System', 'description': 'Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '98.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.013', 'ciLowerLimit': '-0.013', 'ciUpperLimit': '0.040', 'pValueComment': 'The posterior probability of non-inferiority was calculated and presented instead of the p-value.', 'estimateComment': 'The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.', 'groupDescription': 'The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \\> p0 where P0 and P1 are the gait success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \\> -d \\| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.', 'statisticalMethod': 'Bayesian model', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority margin is 0.1.'}, {'pValue': '0.859', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The posterior probability of superiority was calculated and presented instead of the p-value.', 'groupDescription': 'Superiority comparison of gait success rates in two treatment groups was performed if non-inferiority was demonstrated.', 'statisticalMethod': 'Bayesian model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': "Patient's gait was assessed by using Nurick's classification, and indicated either as normal or graded on a scale of 0 to 5. Success was defined as maintenance or improvement in the postoperative status as compared to the preoperative condition: Preoperative Score - Postoperative Score \\>= 0. The gait success rate is reported as the percentage of participants who had gait success.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable gait success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.'}, {'type': 'SECONDARY', 'title': 'Operative Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRESTIGE LP Device', 'description': 'PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.'}, {'id': 'OG001', 'title': 'ATLANTIS Cervical Plate System', 'description': 'Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.400', 'ciLowerLimit': '0.252', 'ciUpperLimit': '0.548', 'pValueComment': 'The posterior probably of superiority was calculated and presented instead of the p-value.', 'estimateComment': 'The posterior mean difference (µ1- µ0) and the corresponding 95% highest posterior density (HPD) interval were presented instead of the usual 95% CI.', 'groupDescription': 'Superiority comparison of the operative time in two treatment groups was assessed. The null hypothesis is H0: μ1 = μ0 and the alternative hypothesis is Ha: μ1 ≠ μ0, where μ0 and μ1 denote the mean in control group the investigational group, respectively. Should the posterior probability of superiority P(μ1- μ0 \\< 0\\|data) be at least 97.5%, the superiority would be claimed.', 'statisticalMethod': 'Bayesian model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Time of operation, an average of 1.7-2.1hrs', 'description': 'Operative time was recorded from skin incision to wound closure.', 'unitOfMeasure': 'hrs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRESTIGE LP Device', 'description': 'PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.'}, {'id': 'OG001', 'title': 'ATLANTIS Cervical Plate System', 'description': 'Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.2', 'spread': '64.1', 'groupId': 'OG000'}, {'value': '55.7', 'spread': '46.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.500', 'ciLowerLimit': '0.560', 'ciUpperLimit': '22.440', 'estimateComment': 'The posterior mean difference (µ1- µ0) and the corresponding 95% highest posterior density (HPD) interval were presented instead of the usual 95% CI.', 'groupDescription': 'Superiority comparison of the blood loss in two treatment groups was assessed.The null hypothesis is H0: μ1 = μ0 and the alternative hypothesis is Ha: μ1 ≠ μ0, where μ0 and μ1 denote the mean in control group the investigational group, respectively. Should the posterior probability of superiority P(μ1- μ0 \\< 0\\|data) be at least 97.5%, the superiority would be claimed.', 'statisticalMethod': 'Bayesian model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'During the time of operation, an average of 1.7-2.1 hrs', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRESTIGE LP Device', 'description': 'PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.'}, {'id': 'OG001', 'title': 'ATLANTIS Cervical Plate System', 'description': 'Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.892', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.100', 'ciLowerLimit': '-0.258', 'ciUpperLimit': '0.058', 'pValueComment': 'The posterior probably of superiority was calculated and presented instead of the p-value.', 'estimateComment': 'The posterior mean difference (µ1- µ0) and the corresponding 95% highest posterior density (HPD) interval were presented instead of the usual 95% CI.', 'groupDescription': 'Superiority comparison of the hospital stay in two treatment groups was assessed.The null hypothesis is H0: μ1 = μ0 and the alternative hypothesis is Ha: μ1 ≠ μ0, where μ0 and μ1 denote the mean in control group the investigational group, respectively. Should the posterior probability of superiority P(μ1- μ0 \\< 0\\|data) be at least 97.5%, the superiority would be claimed.', 'statisticalMethod': 'Bayesian model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From admission to discharge, an average of 1.0-1.5 day', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Secondary Surgery at Index Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRESTIGE LP Device', 'description': 'PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.'}, {'id': 'OG001', 'title': 'ATLANTIS Cervical Plate System', 'description': 'Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '8.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Secondary surgical procedures at the index level included revisions, removals, supplemental fixations and reoperations. Rate of secondary surgery at index level is reported as percentage of subjects who had secondary surgeries at index level.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change of Neck Disability Index Score From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRESTIGE LP Device', 'description': 'PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.'}, {'id': 'OG001', 'title': 'ATLANTIS Cervical Plate System', 'description': 'Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.'}], 'classes': [{'title': 'NDI at baseline (n=209, 188)', 'categories': [{'measurements': [{'value': '52.1', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '53.2', 'spread': '14.8', 'groupId': 'OG001'}]}]}, {'title': 'NDI at 24 months (n=199, 159)', 'categories': [{'measurements': [{'value': '15.0', 'spread': '16.6', 'groupId': 'OG000'}, {'value': '20.0', 'spread': '20.5', 'groupId': 'OG001'}]}]}, {'title': 'NDI change (n=199, 159)', 'categories': [{'measurements': [{'value': '-37.0', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '-32.5', 'spread': '19.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 months post-operation', 'description': 'The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Change of NDI was defined as NDI at 24 month minus NDI at baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change of Neck Pain Score From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRESTIGE LP Device', 'description': 'PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.'}, {'id': 'OG001', 'title': 'ATLANTIS Cervical Plate System', 'description': 'Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.'}], 'classes': [{'title': 'Neck pain at baseline (n=209, 188)', 'categories': [{'measurements': [{'value': '16.2', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '16.3', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Neck pain at 24 months (n=199, 159)', 'categories': [{'measurements': [{'value': '4.3', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'Neck pain change (n=199, 159)', 'categories': [{'measurements': [{'value': '-11.8', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '-10.3', 'spread': '5.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 months post-operation', 'description': 'Numerical rating scales were used to evaluate neck pain intensity and frequency. Subjects rated their neck pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, subjects recorded their neck pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total neck pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of neck pain score was defined as neck pain score at 24 months minus neck pain score at baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change of Arm Pain Score From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRESTIGE LP Device', 'description': 'PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.'}, {'id': 'OG001', 'title': 'ATLANTIS Cervical Plate System', 'description': 'Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.'}], 'classes': [{'title': 'Arm pain at baseline (n=209, 188)', 'categories': [{'measurements': [{'value': '13.8', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '14.4', 'spread': '4.3', 'groupId': 'OG001'}]}]}, {'title': 'Arm pain at 24 months (n=199, 159)', 'categories': [{'measurements': [{'value': '3.0', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '5.6', 'groupId': 'OG001'}]}]}, {'title': 'Arm pain change (n=199, 159)', 'categories': [{'measurements': [{'value': '-10.9', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '-10.2', 'spread': '6.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 months post-operation', 'description': 'Numerical rating scales were also used to evaluate arm pain intensity and frequency. Subjects rated their arm pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, subjects recorded their arm pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total arm pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of arm pain score was defined as arm pain score at 24 months minus arm pain score at baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change of General Health Status -- SF-36 PCS From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRESTIGE LP Device', 'description': 'PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.'}, {'id': 'OG001', 'title': 'ATLANTIS Cervical Plate System', 'description': 'Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.'}], 'classes': [{'title': 'SF-36 PCS at baseline (n=209, 188)', 'categories': [{'measurements': [{'value': '31.8', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '30.8', 'spread': '7.4', 'groupId': 'OG001'}]}]}, {'title': 'SF-36 PCS at 24 months (n=197, 156)', 'categories': [{'measurements': [{'value': '47.3', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '45.4', 'spread': '11.5', 'groupId': 'OG001'}]}]}, {'title': 'SF-36 PCS change (n=197, 156)', 'categories': [{'measurements': [{'value': '15.3', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '13.8', 'spread': '11.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 months post-operation', 'description': 'The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 PCS score was defined as PCS score at 24 months minus PCS score at baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change of General Health Status -- SF-36 MCS From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRESTIGE LP Device', 'description': 'PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.'}, {'id': 'OG001', 'title': 'ATLANTIS Cervical Plate System', 'description': 'Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.'}], 'classes': [{'title': 'SF-36 MCS at baseline (n=209, 188)', 'categories': [{'measurements': [{'value': '43.9', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '43.8', 'spread': '12.2', 'groupId': 'OG001'}]}]}, {'title': 'SF-36 MCS at 24 months (n=197, 156)', 'categories': [{'measurements': [{'value': '52.1', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '50.9', 'spread': '10.5', 'groupId': 'OG001'}]}]}, {'title': 'SF-36 MCS change (n=197, 156)', 'categories': [{'measurements': [{'value': '8.1', 'spread': '14.5', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '12.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 months post-operation', 'description': 'The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 MCS score was defined as MCS score at 24 months minus MCS score at baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PRESTIGE LP Device', 'description': 'PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.'}, {'id': 'FG001', 'title': 'ATLANTIS Cervical Plate System', 'description': 'Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '209'}, {'groupId': 'FG001', 'numSubjects': '188'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '199'}, {'groupId': 'FG001', 'numSubjects': '164'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '397', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PRESTIGE LP Device', 'description': 'PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.'}, {'id': 'BG001', 'title': 'ATLANTIS Cervical Plate System', 'description': 'Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.1', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '47.3', 'spread': '7.7', 'groupId': 'BG001'}, {'value': '47.2', 'spread': '8.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '367', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '67.2', 'spread': '3.9', 'groupId': 'BG000'}, {'value': '67.6', 'spread': '4.0', 'groupId': 'BG001'}, {'value': '67.4', 'spread': '3.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'inches', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '182.1', 'spread': '42.6', 'groupId': 'BG000'}, {'value': '186.3', 'spread': '37.2', 'groupId': 'BG001'}, {'value': '184.0', 'spread': '40.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'lbs', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '28.2', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '28.6', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '28.4', 'spread': '5.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Marital Status', 'classes': [{'title': 'Single', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}, {'title': 'Married', 'categories': [{'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}]}]}, {'title': 'Divorced', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': 'Separated', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Widowed', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education Level', 'classes': [{'title': '<High school', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'High school', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}]}, {'title': '>High school', 'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': "Worker's Compensation", 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '352', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Unresolved Spinal litigation', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '209', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '396', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Alcohol Used', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Preoperative Work Status', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '259', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 397}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'dispFirstSubmitDate': '2011-12-07', 'completionDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-03', 'studyFirstSubmitDate': '2008-03-03', 'dispFirstSubmitQcDate': '2011-12-07', 'resultsFirstSubmitDate': '2016-08-02', 'studyFirstSubmitQcDate': '2008-03-10', 'dispFirstPostDateStruct': {'date': '2011-12-22', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-09-27', 'studyFirstPostDateStruct': {'date': '2008-03-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Overall Success', 'timeFrame': '24 Months', 'description': 'Rate of overall success is reported as the percentage of participants who met all of the following criteria:\n\n1. Postoperative Neck Disability Index (NDI) score improvement of at least a 15-point increase from preoperative;\n2. Maintenance or improvement in neurological status;\n3. No serious adverse event classified as implant associated or implant/surgical procedure associated; and\n4. No additional surgical procedure classified as a "failure."'}], 'secondaryOutcomes': [{'measure': 'Success Rate of Neck Disability Index', 'timeFrame': '24 months', 'description': 'Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met the following criterion: Pre-treatment Score - Post-treatment Score ≥ 15.'}, {'measure': 'Success Rate of Neurological Status', 'timeFrame': '24 months', 'description': 'Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must either remain the same or improve from the time of the preoperative evaluation to the time period evaluated.'}, {'measure': 'Neck Pain Success Rate', 'timeFrame': '24 months', 'description': 'Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and frequency scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Neck pain success rate is reported as the percentage of participants whose neck pain improvement met the following criterion: Preoperative Score - Postoperative Score \\> 0.'}, {'measure': 'Arm Pain Success Rate', 'timeFrame': '24 months', 'description': 'Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and frequency scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Arm pain success rate is reported as the percentage of participants whose arm pain improvement met the following criterion: Preoperative Score - Postoperative Score \\> 0.'}, {'measure': 'Success Rate of SF-36 PCS', 'timeFrame': '24 months', 'description': 'Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 PCS was defined as: Post Score - Pre Score \\>= 0. The Success rate of SF-36 PCS is reported as the percentage of the participants who were classified as a success for SF-36 PCS.'}, {'measure': 'Success Rate of SF-36 MCS', 'timeFrame': '24 months', 'description': 'Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 MCS were defined as: Post Score - Pre Score \\>= 0. The Success rate of SF-36 MCS is reported as the percentage of the participants who were classified as a success for SF-36 MCS.'}, {'measure': 'Rate of Disc Height Success', 'timeFrame': '24 months', 'description': 'Disc height was assessed by determining the Functional Spinal Unit (FSU) height. The rate of disc height success is reported as the percentage of participants whose disc height for each level based on either the anterior or posterior measurements met the following criterion: Postoperative Height - 6 Week Postoperative Height \\>= -2mm'}, {'measure': 'Gait Success Rate', 'timeFrame': '24 months', 'description': "Patient's gait was assessed by using Nurick's classification, and indicated either as normal or graded on a scale of 0 to 5. Success was defined as maintenance or improvement in the postoperative status as compared to the preoperative condition: Preoperative Score - Postoperative Score \\>= 0. The gait success rate is reported as the percentage of participants who had gait success."}, {'measure': 'Operative Time', 'timeFrame': 'Time of operation, an average of 1.7-2.1hrs', 'description': 'Operative time was recorded from skin incision to wound closure.'}, {'measure': 'Blood Loss', 'timeFrame': 'During the time of operation, an average of 1.7-2.1 hrs'}, {'measure': 'Hospital Stay', 'timeFrame': 'From admission to discharge, an average of 1.0-1.5 day'}, {'measure': 'Rate of Secondary Surgery at Index Level', 'timeFrame': '24 months', 'description': 'Secondary surgical procedures at the index level included revisions, removals, supplemental fixations and reoperations. Rate of secondary surgery at index level is reported as percentage of subjects who had secondary surgeries at index level.'}, {'measure': 'Change of Neck Disability Index Score From Baseline', 'timeFrame': 'Baseline and 24 months post-operation', 'description': 'The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Change of NDI was defined as NDI at 24 month minus NDI at baseline.'}, {'measure': 'Change of Neck Pain Score From Baseline', 'timeFrame': 'Baseline and 24 months post-operation', 'description': 'Numerical rating scales were used to evaluate neck pain intensity and frequency. Subjects rated their neck pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, subjects recorded their neck pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total neck pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of neck pain score was defined as neck pain score at 24 months minus neck pain score at baseline.'}, {'measure': 'Change of Arm Pain Score From Baseline', 'timeFrame': 'Baseline and 24 months post-operation', 'description': 'Numerical rating scales were also used to evaluate arm pain intensity and frequency. Subjects rated their arm pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, subjects recorded their arm pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total arm pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of arm pain score was defined as arm pain score at 24 months minus arm pain score at baseline.'}, {'measure': 'Change of General Health Status -- SF-36 PCS From Baseline', 'timeFrame': 'Baseline and 24 months post-operation', 'description': 'The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 PCS score was defined as PCS score at 24 months minus PCS score at baseline.'}, {'measure': 'Change of General Health Status -- SF-36 MCS From Baseline', 'timeFrame': 'Baseline and 24 months post-operation', 'description': 'The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 MCS score was defined as MCS score at 24 months minus MCS score at baseline.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Symptomatic DDD at Two Adjacent Levels of cervical spine'], 'conditions': ['Cervical Degenerative Disc Disease', 'Radiculopathy', 'Myelopathy']}, 'referencesModule': {'references': [{'pmid': '31970051', 'type': 'DERIVED', 'citation': 'Gornet MF, Lanman TH, Burkus JK, Hodges SD, McConnell JR, Dryer RF, Schranck FW, Copay AG. One-Level Versus 2-Level Treatment With Cervical Disc Arthroplasty or Fusion: Outcomes Up to 7 Years. Int J Spine Surg. 2019 Dec 31;13(6):551-560. doi: 10.14444/6076. eCollection 2019 Dec.'}, {'pmid': '31226684', 'type': 'DERIVED', 'citation': 'Gornet MF, Lanman TH, Burkus JK, Dryer RF, McConnell JR, Hodges SD, Schranck FW. Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial. J Neurosurg Spine. 2019 Jun 21;31(4):508-518. doi: 10.3171/2019.4.SPINE19157. Print 2019 Oct 1.'}, {'pmid': '28387616', 'type': 'DERIVED', 'citation': 'Lanman TH, Burkus JK, Dryer RG, Gornet MF, McConnell J, Hodges SD. Long-term clinical and radiographic outcomes of the Prestige LP artificial cervical disc replacement at 2 levels: results from a prospective randomized controlled clinical trial. J Neurosurg Spine. 2017 Jul;27(1):7-19. doi: 10.3171/2016.11.SPINE16746. Epub 2017 Apr 7.'}, {'pmid': '28304237', 'type': 'DERIVED', 'citation': 'Gornet MF, Lanman TH, Burkus JK, Hodges SD, McConnell JR, Dryer RF, Copay AG, Nian H, Harrell FE Jr. Cervical disc arthroplasty with the Prestige LP disc versus anterior cervical discectomy and fusion, at 2 levels: results of a prospective, multicenter randomized controlled clinical trial at 24 months. J Neurosurg Spine. 2017 Jun;26(6):653-667. doi: 10.3171/2016.10.SPINE16264. Epub 2017 Mar 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical investigation is to assess the safety and effectiveness of using the PRESTIGE-LP device in the treatment of patients with symptomatic degenerative disc disease at two adjacent levels of the cervical spine, with overall success being the primary endpoint of the clinical trial. The primary objective is to show non-inferiority of the investigational device to the control treatment. If non-inferiority is established, superiority will also be examined as the secondary objective.', 'detailedDescription': "This clinical investigation is being conducted to evaluate the PRESTIGE-LP device's performance at two adjacent cervical levels (C3-C7) in the treatment of patients with symptomatic degenerative disc disease. One-half of the patients in this randomized pivotal clinical trial will be treated at two adjacent cervical levels with the PRESTIGE-LP device. The remaining patients will receive a bi-level anterior cervical discectomy and fusion with cortical ring allografts and the ATLANTIS Cervical Plate System."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has cervical DDD at 2 adjacent cervical levels (C3-C7) requiring surgical treatment \\& involving intractable radiculopathy, myelopathy, or both\n* Has a herniated disc and/or osteophyte formation at each level to be treated that is producing symptomatic nerve root and/or spinal cord compression. The condition is documented by patient history, and the requirement for surgical treatment is evidenced by radiographic studies\n* Unresponsive to non-operative treatment for approximately 6 weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management\n* Has no previous surgical intervention at the involved levels or any subsequent planned/staged surgical procedure at the involved or adjacent level(s)\n* Must be ≥ 18 years; skeletally mature at time of surgery\n* Preoperative NDI score ≥ 30\n* Preoperative neck pain score ≥ 8 based on the preoperative Neck and Arm Pain Questionnaire\n* If a female of childbearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant during the study period\n* Is willing to comply with the study plan and sign Patient Informed Consent Form\n\nExclusion Criteria:\n\n* Has a cervical spinal condition other than symptomatic cervical DDD requiring surgical treatment at the involved levels\n* Has documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion/extension) radiographs showing: Sagittal plane translation \\> 3.5 mm, or Sagittal plane angulation \\> 20 degrees.\n* Has more than two cervical levels requiring surgical treatment\n* Has a fused level adjacent to the levels to be treated\n* Has severe pathology of the facet joints of the involved vertebral bodies\n* Has had previous surgical intervention at either one or both of the involved levels or at adjacent levels\n* Has been previously diagnosed with osteopenia or osteomalacia\n* Has any of the following that may be associated with a diagnosis of osteoporosis (If "Yes" to any of the below a DEXA Scan will be required to determine eligibility.)\n\n * Postmenopausal non-Black female over age of 60 who weighs \\< 140 pounds\n * Postmenopausal female who has sustained a non-traumatic hip, spine, or wrist fracture\n * Male \\> 70 years\n * Male \\> 60 years who has sustained a non-traumatic hip or spine fracture\n * If the level of BMD is a T score of -3.5 or lower or a T score of -2.5 or lower with vertebral crush fracture, then the patient is excluded from the study\n* Has presence of spinal metastases\n* Has overt or active bacterial infection, either local or systemic\n* Has insulin dependent diabetes\n* Is a tobacco user who does not agree to suspend smoking prior to surgery\n* Has chronic or acute renal failure or prior history of renal disease\n* Has a documented allergy or intolerance to stainless steel, titanium, or a titanium alloy\n* Is mentally incompetent (If questionable, obtain psychiatric consult)\n* Is a prisoner\n* Is pregnant\n* Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse\n* Is involved with current or pending litigation regarding a spinal condition\n* Has received drugs that may interfere with bone metabolism within two weeks prior to the planned date of spinal surgery (e.g., steroids or methotrexate), excluding routine perioperative anti-inflammatory drugs\n* Has a history of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget\'s Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta)\n* Has a condition that requires postoperative medications that interfere with the stability of the implant, such as steroids. (This does not include low-dose aspirin for prophylactic anticoagulation and routine perioperative anti-inflammatory drugs.)\n* Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following implantation'}, 'identificationModule': {'nctId': 'NCT00637156', 'briefTitle': 'Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Spinal and Biologics'}, 'officialTitle': 'A Prospective, Randomized, Controlled, Multicenter Pivotal Clinical Trial of the Artificial Cervical Disc-LP at Two Levels for Symptomatic Cervical Disc Disease', 'orgStudyIdInfo': {'id': 'PRESTIGE LP Two Level Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRESTIGE LP Device', 'interventionNames': ['Device: PRESTIGE LP device at two adjacent levels']}, {'type': 'OTHER', 'label': 'ATLANTIS Cervical Plate System', 'interventionNames': ['Device: Bi-level fusion with ATLANTIS Cervical Plate System']}], 'interventions': [{'name': 'PRESTIGE LP device at two adjacent levels', 'type': 'DEVICE', 'otherNames': ['disc', 'artificial disc', 'cervical disc'], 'description': 'PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.', 'armGroupLabels': ['PRESTIGE LP Device']}, {'name': 'Bi-level fusion with ATLANTIS Cervical Plate System', 'type': 'DEVICE', 'otherNames': ['plate', 'cervical plate', 'fusion', 'cervical fusion'], 'description': 'Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.', 'armGroupLabels': ['ATLANTIS Cervical Plate System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'The Orthopaedic Center; Crestwood Medical Center', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Todd Lanman, MD, FACS, A Professional Corp.;', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92324', 'city': 'Colton', 'state': 'California', 'country': 'United States', 'facility': 'Bone & Spine Surgery', 'geoPoint': {'lat': 34.0739, 'lon': -117.31365}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'La Jolla Neurological Associates, AMC; Scripps Memorial Hospital La Jolla; Scripps Memorial Hospital Encinitas', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94117', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': "St. Mary's Spine Center; St. Mary's Hospital", 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Delaware Neurosurgical Group; Christiana Care Health Systems', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '32405', 'city': 'Panama City', 'state': 'Florida', 'country': 'United States', 'facility': 'Spinal Associates, Gulf Coast Hospital', 'geoPoint': {'lat': 30.15946, 'lon': -85.65983}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Peachtree Neurosurgery, Northside Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '31908', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Hughston Clinic, P.C., Hughston Hospital and Rehabilitation Center', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Neuro Spine & Pain Center; Lutheran Hospital', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals & Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '49505', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Great Lakes Neurosurgical; Spectrum Health East Campus', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '48604', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'facility': 'Adams Neurosurgery; Mid Michigan Medical Center', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '48322', 'city': 'West Bloomfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.56891, 'lon': -83.38356}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'The Orthopedic Center of St. Louis; Barnes Jewish West County Hospital', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '59802', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': "Montana Neuro Science Institute; St. Patrick's Medical Center", 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'University at Buffalo Neurosurgery, Inc. Kaleida Health-Buffalo General Medical center/Gates Vascular Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '14224', 'city': 'West Seneca', 'state': 'New York', 'country': 'United States', 'facility': 'Buffalo Neurosurgery Group', 'geoPoint': {'lat': 42.85006, 'lon': -78.79975}}, {'zip': '44333', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Crystal Clinic, Inc.; Akron General Medical Center', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '43081', 'city': 'Westerville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Central Ohio Neurological Surgeons; Mt. Carmel East Hospital', 'geoPoint': {'lat': 40.12617, 'lon': -82.92907}}, {'zip': '97701', 'city': 'Bend', 'state': 'Oregon', 'country': 'United States', 'facility': 'The Center Orthopaedic & Neurosurgical Care & Research', 'geoPoint': {'lat': 44.05817, 'lon': -121.31531}}, {'zip': '18104', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'OAA Orthopaedic Specialists', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny Neurosurgery; Washington Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29169', 'city': 'West Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Lexington Brain and Spine Institute', 'geoPoint': {'lat': 33.99349, 'lon': -81.07398}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Center for Sports Medicine and Orthopaedics; Memorial Hospital', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37604', 'city': 'Johnson City', 'state': 'Tennessee', 'country': 'United States', 'facility': 'East Tennessee Brain & Spine Center, Johnson City Medical Center', 'geoPoint': {'lat': 36.31344, 'lon': -82.35347}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Central Texas Spine Institute; Health South Surgical Center', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '22601', 'city': 'Winchester', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Brain and Spine; Winchester Medical Center', 'geoPoint': {'lat': 39.18566, 'lon': -78.16333}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University; Ruby Memorial Hospital, WVU Hospitals, Inc.', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'John K Burkus, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hughston Clinic, P.C.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Spinal and Biologics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}