Ignite Creation Date:
2025-12-24 @ 3:58 PM
Ignite Modification Date:
2026-02-25 @ 8:27 PM
Study NCT ID:
NCT00534092
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2007-09-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-Term Outcomes for Lumbar Spinal Stenosis Patients Treated With X STOP®
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013130', 'term': 'Spinal Stenosis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'msbkclinicalresearch@medtronic.com', 'phone': '1800-876-3133', 'title': 'Clinical Department', 'phoneExt': '6068', 'organization': 'Medtronic Spine and Biologics'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '3+ years following first 2 years post-X-STOP implant through IDE study', 'description': 'An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified.\n\nPatients may have had multiple adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Target', 'description': 'Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score \\>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).', 'otherNumAtRisk': 55, 'otherNumAffected': 48, 'seriousNumAtRisk': 55, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Safety', 'description': 'Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.', 'otherNumAtRisk': 14, 'otherNumAffected': 13, 'seriousNumAtRisk': 14, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Total', 'description': 'Total patients included target group and safety group.', 'otherNumAtRisk': 69, 'otherNumAffected': 61, 'seriousNumAtRisk': 69, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'factor v leiden mutation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'deafness neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'acromegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'thyroid disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'oesophageal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'drug withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'multiple allergies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'post-traumatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'pedal pulse decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'hypocholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'back disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastrointestinal arteriovenous malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 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pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Spinal claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardiac pacemaker insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hip surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Intervertebral disc operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Spinal fusion surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment Success Rates (At ≥ 5 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Target', 'description': 'Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score \\>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).'}, {'id': 'OG001', 'title': 'Safety', 'description': 'Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.'}, {'id': 'OG002', 'title': 'Total', 'description': 'Total patients included target group and safety group.'}], 'classes': [{'title': 'Treatment success rate (n=49, 13, 62)', 'categories': [{'measurements': [{'value': '40.8', 'groupId': 'OG000'}, {'value': '30.8', 'groupId': 'OG001'}, {'value': '38.7', 'groupId': 'OG002'}]}]}, {'title': 'SS improved >=0.5 point (n=52, 13, 65)', 'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000'}, {'value': '84.6', 'groupId': 'OG001'}, {'value': '60.0', 'groupId': 'OG002'}]}]}, {'title': 'PF improved >=0.5 point (n=52, 14, 66)', 'categories': [{'measurements': [{'value': '73.1', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '68.2', 'groupId': 'OG002'}]}]}, {'title': 'PS Score <2.5 (n=53, 14, 67)', 'categories': [{'measurements': [{'value': '81.1', 'groupId': 'OG000'}, {'value': '92.9', 'groupId': 'OG001'}, {'value': '83.6', 'groupId': 'OG002'}]}]}, {'title': 'No additional surgery at index level(n=53, 14, 67)', 'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '95.5', 'groupId': 'OG002'}]}]}, {'title': 'Maintenance of distraction (n=42, 11, 53)', 'categories': [{'measurements': [{'value': '95.2', 'groupId': 'OG000'}, {'value': '90.9', 'groupId': 'OG001'}, {'value': '94.3', 'groupId': 'OG002'}]}]}, {'title': 'No dislodgement of implant (n=43, 11, 54)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '81.8', 'groupId': 'OG001'}, {'value': '96.3', 'groupId': 'OG002'}]}]}, {'title': 'No device-related complication (n=53, 14, 67)', 'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '92.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3+ years following first 2 years post-X-STOP implant through IDE study', 'description': 'Seven treatment success criteria were defined as follows: clinically significant improvement (at least 0.5 points) in Symptom Severity (SS) domain of Zurich Claudication Questionnaire (ZCQ), clinically significant improvement (at least 0.5 points) in Physical Function (PF) domain of ZCQ, Patient Satisfaction (PS) score of \\<2.5 points in ZCQ, no additional lumbar spinal stenosis surgery at the index level, maintenance of distraction, no device dislodgement, no device-related complications. All 7 criteria must be met to be considered a treatment success.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who received the X-STOP and 1) completed the IDE trial or CAP/COS under IDE #G990128 or 2) were participating in the CAP/COS program, were eligible for the LTOS study. 55 included in analysis met moderately impaired baseline physical function. 14 had mildly impaired physical function at baseline and were analyzed as separate safety cohort.'}, {'type': 'SECONDARY', 'title': 'Change in Symptom Severity (SS) and Physical Functioning (PF) as Using Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Target', 'description': 'Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score \\>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).'}, {'id': 'OG001', 'title': 'Safety', 'description': 'Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.'}, {'id': 'OG002', 'title': 'Total', 'description': 'Total patients included target group and safety group.'}], 'classes': [{'title': 'Mean Change in SS (n=52, 13, 65)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Mean change in PF (n=52, 14, 66)', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '0.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study', 'description': 'ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). SS domain is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance). The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire ranging from 1to 5. If more than two items were missing, the SS score was considered as missing. PF score is the mean of five physical function questions ranging from 1 to 4. If more than one item were missing, the PF score was considered as missing. In each domain, a lower score represents a better outcome/condition. The change is calculated as the score at 5+ years after X-STOP implantation minus the baseline score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction (PS) as Assessed by Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Target', 'description': 'Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score \\>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).'}, {'id': 'OG001', 'title': 'Safety', 'description': 'Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.'}, {'id': 'OG002', 'title': 'Total', 'description': 'Total patients included target group and safety group.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '0.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3+ years following first 2 years post-X-STOP implant through IDE study', 'description': 'ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). PS score is the mean of 6 questions scored from 1 to 4 if the number of responses exceeded four, a lower score represents a better outcome. Patients with mean scores \\<2.5 at 5 years postoperative evaluation were considered positive, which implied patient treatment satisfaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Target', 'description': 'Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score \\>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).'}, {'id': 'OG001', 'title': 'Safety', 'description': 'Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.'}, {'id': 'OG002', 'title': 'Total', 'description': 'Total patients included target group and safety group.'}], 'classes': [{'title': 'Bodily Pain (n=52, 14, 66)', 'categories': [{'measurements': [{'value': '23.4', 'spread': '26.2', 'groupId': 'OG000'}, {'value': '31.1', 'spread': '19.9', 'groupId': 'OG001'}, {'value': '25.0', 'spread': '25.1', 'groupId': 'OG002'}]}]}, {'title': 'General Health (n=52, 14, 66)', 'categories': [{'measurements': [{'value': '-5.4', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '11.4', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '13.6', 'groupId': 'OG002'}]}]}, {'title': 'MCS (n=49, 13, 62)', 'categories': [{'measurements': [{'value': '3.9', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '8.9', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '11.9', 'groupId': 'OG002'}]}]}, {'title': 'Mental Health (n=52, 14, 66)', 'categories': [{'measurements': [{'value': '3.8', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '10.9', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '17.9', 'groupId': 'OG002'}]}]}, {'title': 'PCS (n=49, 13, 62)', 'categories': [{'measurements': [{'value': '8.6', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '11.6', 'spread': '9.2', 'groupId': 'OG001'}, {'value': '9.2', 'spread': '10.2', 'groupId': 'OG002'}]}]}, {'title': 'Physical Functioning (n=52, 14, 66)', 'categories': [{'measurements': [{'value': '28.0', 'spread': '30.0', 'groupId': 'OG000'}, {'value': '27.1', 'spread': '15.9', 'groupId': 'OG001'}, {'value': '27.8', 'spread': '27.5', 'groupId': 'OG002'}]}]}, {'title': 'Role-Emotional (n=50, 13, 63)', 'categories': [{'measurements': [{'value': '24.0', 'spread': '58.7', 'groupId': 'OG000'}, {'value': '35.9', 'spread': '44.0', 'groupId': 'OG001'}, {'value': '26.5', 'spread': '55.9', 'groupId': 'OG002'}]}]}, {'title': 'Role-Physical (n=50, 14, 64)', 'categories': [{'measurements': [{'value': '28.5', 'spread': '51.8', 'groupId': 'OG000'}, {'value': '50.0', 'spread': '42.7', 'groupId': 'OG001'}, {'value': '33.2', 'spread': '50.4', 'groupId': 'OG002'}]}]}, {'title': 'Social Functioning (n=52, 14, 66)', 'categories': [{'measurements': [{'value': '32.0', 'spread': '34.9', 'groupId': 'OG000'}, {'value': '15.2', 'spread': '23.1', 'groupId': 'OG001'}, {'value': '28.4', 'spread': '33.3', 'groupId': 'OG002'}]}]}, {'title': 'Vitality (n=52, 14, 66)', 'categories': [{'measurements': [{'value': '7.9', 'spread': '25.2', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '14.3', 'groupId': 'OG001'}, {'value': '8.3', 'spread': '23.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study', 'description': 'Quality of life was assessed by the SF-36 health survey. It includes 8 subdomains (bodily pain, physical functioning, role-physical, general health and vitality, social functioning, role-emotional, and mental health) and 2 component summaries (physical component summary \\[PCS\\] and mental component summary \\[MCS\\]). Scores for each subdomain and component summary range from 0 "worst" to 100 "best. The change from baseline to the 5 year postoperative visit for each of these domains is presented.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Target', 'description': 'Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score \\>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).'}, {'id': 'OG001', 'title': 'Safety', 'description': 'Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.'}, {'id': 'OG002', 'title': 'Total', 'description': 'Total patients included target group and safety group.'}], 'classes': [{'title': 'Number of Patients with Subsequent surgeries', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Number of Patients with Revision', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Number of Patients with Removal', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Number of Patients with Re-operations', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Number of Patients with Supplemental Fixations', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Number of Patients with other subsequent surgeries', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3+ years following first 2 years post-X-STOP implant through IDE study', 'description': 'The surgeries that occurred subsequent to the original X-STOP implantation were categorized as revision, removal, reoperation, supplemental fixation, and other.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Target', 'description': 'Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score \\>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).'}, {'id': 'OG001', 'title': 'Safety', 'description': 'Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.'}, {'id': 'OG002', 'title': 'Total', 'description': 'Total patients included target group and safety group.'}], 'classes': [{'title': 'Implant related', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Procedure related', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Implant & Procedure related', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Undetermined', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Not related', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3+ years following first 2 years post-X-STOP implant through IDE study', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Target', 'description': 'Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score \\>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).'}, {'id': 'FG001', 'title': 'Safety', 'description': 'Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'personal reasons/family concerns', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Target', 'description': 'Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score \\>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).'}, {'id': 'BG001', 'title': 'Safety', 'description': 'Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.1', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '76.0', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '72.9', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian / Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-10', 'studyFirstSubmitDate': '2007-09-20', 'resultsFirstSubmitDate': '2011-06-02', 'studyFirstSubmitQcDate': '2007-09-21', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-07-27', 'studyFirstPostDateStruct': {'date': '2007-09-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-07-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study', 'timeFrame': '3+ years following first 2 years post-X-STOP implant through IDE study', 'description': 'The surgeries that occurred subsequent to the original X-STOP implantation were categorized as revision, removal, reoperation, supplemental fixation, and other.'}, {'measure': 'Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study', 'timeFrame': '3+ years following first 2 years post-X-STOP implant through IDE study'}], 'primaryOutcomes': [{'measure': 'Treatment Success Rates (At ≥ 5 Years)', 'timeFrame': '3+ years following first 2 years post-X-STOP implant through IDE study', 'description': 'Seven treatment success criteria were defined as follows: clinically significant improvement (at least 0.5 points) in Symptom Severity (SS) domain of Zurich Claudication Questionnaire (ZCQ), clinically significant improvement (at least 0.5 points) in Physical Function (PF) domain of ZCQ, Patient Satisfaction (PS) score of \\<2.5 points in ZCQ, no additional lumbar spinal stenosis surgery at the index level, maintenance of distraction, no device dislodgement, no device-related complications. All 7 criteria must be met to be considered a treatment success.'}], 'secondaryOutcomes': [{'measure': 'Change in Symptom Severity (SS) and Physical Functioning (PF) as Using Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years)', 'timeFrame': 'Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study', 'description': 'ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). SS domain is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance). The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire ranging from 1to 5. If more than two items were missing, the SS score was considered as missing. PF score is the mean of five physical function questions ranging from 1 to 4. If more than one item were missing, the PF score was considered as missing. In each domain, a lower score represents a better outcome/condition. The change is calculated as the score at 5+ years after X-STOP implantation minus the baseline score.'}, {'measure': 'Patient Satisfaction (PS) as Assessed by Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years)', 'timeFrame': '3+ years following first 2 years post-X-STOP implant through IDE study', 'description': 'ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). PS score is the mean of 6 questions scored from 1 to 4 if the number of responses exceeded four, a lower score represents a better outcome. Patients with mean scores \\<2.5 at 5 years postoperative evaluation were considered positive, which implied patient treatment satisfaction.'}, {'measure': 'Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years)', 'timeFrame': 'Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study', 'description': 'Quality of life was assessed by the SF-36 health survey. It includes 8 subdomains (bodily pain, physical functioning, role-physical, general health and vitality, social functioning, role-emotional, and mental health) and 2 component summaries (physical component summary \\[PCS\\] and mental component summary \\[MCS\\]). Scores for each subdomain and component summary range from 0 "worst" to 100 "best. The change from baseline to the 5 year postoperative visit for each of these domains is presented.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lumbar Spinal Stenosis', 'X STOP'], 'conditions': ['Lumbar Spinal Stenosis']}, 'referencesModule': {'references': [{'pmid': '17176013', 'type': 'BACKGROUND', 'citation': 'Hsu KY, Zucherman JF, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ, Johnson DR 2nd, Skidmore GA, Vessa PP, Dwyer JW, Cauthen JC, Ozuna RM. Quality of life of lumbar stenosis-treated patients in whom the X STOP interspinous device was implanted. J Neurosurg Spine. 2006 Dec;5(6):500-7. doi: 10.3171/spi.2006.5.6.500.'}, {'pmid': '15959362', 'type': 'BACKGROUND', 'citation': 'Zucherman JF, Hsu KY, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ, Johnson DR 2nd, Skidmore GA, Vessa PP, Dwyer JW, Puccio ST, Cauthen JC, Ozuna RM. A multicenter, prospective, randomized trial evaluating the X STOP interspinous process decompression system for the treatment of neurogenic intermittent claudication: two-year follow-up results. Spine (Phila Pa 1976). 2005 Jun 15;30(12):1351-8. doi: 10.1097/01.brs.0000166618.42749.d1.'}]}, 'descriptionModule': {'briefSummary': 'The Long-Term Outcomes Study (LTOS) is a multi-center longitudinal cohort study of all patients who received the X-STOP device in the Pivotal Trial, Continued Access Protocol (CAP), or Cross-over Study (COS). It is designed to supplement postmarket safety and effectiveness data to be gathered in a Condition of Approval (CoA) study of a population of patients with moderately impaired physical function who elect to undergo X-STOP surgery.', 'detailedDescription': 'Evaluate the long term safety and effectiveness of the X-Stop interspinous process decompression system In the patients who received the X-Stop under the IDE. These patients consist of two cohorts to be evaluated: patients who had moderately impaired physical function prior to X-Stop implantation (as determined by a baseline score \\>2.0 in the physical function (PF) domain of the Zurich claudication questionnaire), and patients who had mildly impaired physical function prior to X-Stop surgery(as determined by a baseline score \\<=2.0 in the PF domain of the Zurich claudication questionnaire (ZCQ), through the fifth postoperative year. Clinical examination will be performed at each office visit to confirm the absence of neurological complications. X-ray films (AP/lateral views) taken during the fifth postoperative year will, be analyzed to confirm A) maintenance of distraction and B) the absence of radiological evidence of device-related complications. Secondary endpoints will include mean scores from the SF-36, and incidence rates of adverse events, device failures, and secondary surgeries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who received implants and completed participation in the Pivotal, CAP, or COS studies and has the implant intact and is willing and able to provide consent and return to the clinic for evaluation or complete study questionnaires.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nA patient will be admitted into the LTOS program if he/she meets all of the following inclusion criteria:\n\n1. Completed participation in the Pivotal Trial, CAP, or COS and has the X STOP implant(s) intact at the time of LTOS enrollment; OR is an active CAP/COS participant, has the X STOP implant(s) intact, and has not completed a 24-month follow-up visit in his/her CAP/COS study.\n2. Is willing and able to provide Informed Consent\n3. Is willing and able to return to the clinic for a clinical evaluation or complete study questionnaires without a clinic visit.\n\nExclusion Criteria:\n\nA patient will not be admitted into the LTOS program if he/she meets any of the following exclusion criteria:\n\n1. Participated in the Pivotal Trial as part of the X STOP group, but the device has been removed.\n2. Participated in the CAP or COS programs, but the device has been removed.'}, 'identificationModule': {'nctId': 'NCT00534092', 'briefTitle': 'Long-Term Outcomes for Lumbar Spinal Stenosis Patients Treated With X STOP®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Spinal and Biologics'}, 'officialTitle': 'Long-term Outcomes Among Patients With Lumbar Spinal Stenosis Treated With the X STOP® Interspinous Process Decompression System: Five-Year Follow-up of IDE Patient Cohorts', 'orgStudyIdInfo': {'id': 'LSS-004-LTO'}}, 'armsInterventionsModule': {'interventions': [{'name': 'X STOP® Interspinous Process Decompression System', 'type': 'DEVICE', 'description': 'The X STOP is a titanium implant that fits between the spinous processes of the lumbar spine. It is made from Ti-6AI-4V Eli titanium alloy (ISO 5832/3) and consists of two components: a spacer assembly and a wing assembly.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94117', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': "St. Mary's Spine Center", 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '04074', 'city': 'Scarborough', 'state': 'Maine', 'country': 'United States', 'facility': 'Neurological & Spine Associates', 'geoPoint': {'lat': 43.57814, 'lon': -70.32172}}, {'zip': '21093', 'city': 'Timonium', 'state': 'Maryland', 'country': 'United States', 'facility': 'Greater Baltimore Spine Care', 'geoPoint': {'lat': 39.43705, 'lon': -76.61969}}, {'zip': '23510', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Neurological Specialist', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University Hospital', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Spine LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}