Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT00905359
Status:
COMPLETED
Last Update Posted:
2017-02-10
First Post:
2009-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neurogenic Intermittent Claudication Evaluation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark', 'Netherlands']}, '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 Spinal and Biologics'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Overall study period, up to 24 months', 'eventGroups': [{'id': 'EG000', 'title': 'Aperius™ PercLID™ System', 'description': 'Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.', 'otherNumAtRisk': 77, 'otherNumAffected': 53, 'seriousNumAtRisk': 77, 'seriousNumAffected': 26}, {'id': 'EG001', 'title': 'Standalone Decompressive Surgery', 'description': 'Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.', 'otherNumAtRisk': 75, 'otherNumAffected': 57, 'seriousNumAtRisk': 75, 'seriousNumAffected': 25}], 'otherEvents': [{'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Faecal inconsistence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Prostate infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Back injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Dural tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Factured coccyx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Factured sacrum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Muscle injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Post procedural constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Post-traumatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Procedural nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Subcutaneous haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Wound discence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Biopsy stomach', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 24, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Buttock pain Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Epicondylitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Intervertebral disc compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Intervertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Osteitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Sacroiliitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Tenosynovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Meralgia paraesthetica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': "Parkinson's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Radiculitis lumbosacral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Restless legs syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders'}, {'term': 'Sensory abnormalities NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Sensory disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Prurigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Implant site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Orchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Parotitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Confusion postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Dural tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Extradural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Neurological and psychiatric procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Abdominal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Facet joint syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Peroneal nerve palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Radiculitis lumbosacral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Spinal claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Vertebral foraminal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cystocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Coronary arterial stent insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Gastric banding reversal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Femoral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '0.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Percentage Change From Baseline in Physical Function at 1 Year Follow-up Using the Patient Completed Zurich Claudication Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aperius™ PercLID™ System', 'description': 'Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.'}, {'id': 'OG001', 'title': 'Standalone Decompressive Surgery', 'description': 'Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '-32.31', 'spread': '32.06', 'groupId': 'OG000'}, {'value': '-37.48', 'spread': '22.79', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.172', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 't-test analysis performed using Multiple imputation and one-sided p-value testing non-inferiority of the percentage change from baseline at 10%. One-sided p-value is significant if \\<0.025 or the upper limit of the CI is less than 10%.'}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: Physical function (PF), Symptom Severity (SS), and post-treatment Patient Satisfaction (PS).PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. Mean percentage change from baseline in Physical Function at 1 year follow-up was reported.', 'unitOfMeasure': 'percentage change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).'}, {'type': 'SECONDARY', 'title': 'Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aperius™ PercLID™ System', 'description': 'Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.'}, {'id': 'OG001', 'title': 'Standalone Decompressive Surgery', 'description': 'Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.'}], 'classes': [{'title': 'at 14 days', 'categories': [{'measurements': [{'value': '-19.70', 'spread': '28.87', 'groupId': 'OG000'}, {'value': '-18.52', 'spread': '28.07', 'groupId': 'OG001'}]}]}, {'title': 'at 6 weeks', 'categories': [{'measurements': [{'value': '-32.17', 'spread': '27.36', 'groupId': 'OG000'}, {'value': '-34.60', 'spread': '24.19', 'groupId': 'OG001'}]}]}, {'title': 'at 6 months', 'categories': [{'measurements': [{'value': '-34.94', 'spread': '25.92', 'groupId': 'OG000'}, {'value': '-38.11', 'spread': '21.70', 'groupId': 'OG001'}]}]}, {'title': 'at 24 months', 'categories': [{'measurements': [{'value': '-37.86', 'spread': '21.72', 'groupId': 'OG000'}, {'value': '-35.15', 'spread': '22.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days, 6 weeks, 6 months, and 24 months', 'description': 'ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: Physical function (PF), Symptom Severity (SS), and post-treatment Patient Satisfaction (PS).PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. Mean percentage change from baseline in Physical Function at 14 days, 6 weeks, 6 months, and 24 months was reported.', 'unitOfMeasure': 'percentage change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).'}, {'type': 'SECONDARY', 'title': 'Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aperius™ PercLID™ System', 'description': 'Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.'}, {'id': 'OG001', 'title': 'Standalone Decompressive Surgery', 'description': 'Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.'}], 'classes': [{'title': 'At 14 days (n=67, 66)', 'categories': [{'measurements': [{'value': '-34.38', 'spread': '19.32', 'groupId': 'OG000'}, {'value': '-27.92', 'spread': '19.32', 'groupId': 'OG001'}]}]}, {'title': 'At 6 weeks (n=66, 68)', 'categories': [{'measurements': [{'value': '-35.72', 'spread': '22.08', 'groupId': 'OG000'}, {'value': '-36.38', 'spread': '19.26', 'groupId': 'OG001'}]}]}, {'title': 'at 6 months (n=60, 62)', 'categories': [{'measurements': [{'value': '-33.86', 'spread': '21.70', 'groupId': 'OG000'}, {'value': '-34.18', 'spread': '19.84', 'groupId': 'OG001'}]}]}, {'title': 'At 12 months (n=60, 63)', 'categories': [{'measurements': [{'value': '-31.24', 'spread': '26.85', 'groupId': 'OG000'}, {'value': '-36.40', 'spread': '24.53', 'groupId': 'OG001'}]}]}, {'title': 'At 24 months (n=50, 57)', 'categories': [{'measurements': [{'value': '-40.25', 'spread': '21.91', 'groupId': 'OG000'}, {'value': '-32.78', 'spread': '23.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14days, 6 week, 6 months, 12 months, 24 months', 'description': 'ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment PS. SS Score is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance) in ZCQ. 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 1 to 5. A lower score represents a better outcome/condition. Mean percentage of change from baseline in Symptom Severity is reported.', 'unitOfMeasure': 'percentage change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aperius™ PercLID™ System', 'description': 'Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.'}, {'id': 'OG001', 'title': 'Standalone Decompressive Surgery', 'description': 'Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.'}], 'classes': [{'title': 'PS score at 14 days', 'categories': [{'measurements': [{'value': '1.76', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '1.77', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'PS score at 6 weeks', 'categories': [{'measurements': [{'value': '1.71', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '1.64', 'spread': '0.48', 'groupId': 'OG001'}]}]}, {'title': 'PS score at 6 months', 'categories': [{'measurements': [{'value': '1.73', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '1.67', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'PS score at 12 months', 'categories': [{'measurements': [{'value': '1.73', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '1.73', 'spread': '0.70', 'groupId': 'OG001'}]}]}, {'title': 'PS score at 24 months', 'categories': [{'measurements': [{'value': '1.68', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '1.72', 'spread': '0.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days, 6 weeks, 6 months, 12 months, and 24 months', 'description': 'PS score is the mean score of 6 questions of ZCQ, ranging from 1 to 4 if the number of responses exceeded four. A lower score represents a better outcome. Patients with PS score less than 2.5 at postoperative evaluation were considered positive, which implied that patients were satisfied with their treatment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).'}, {'type': 'SECONDARY', 'title': 'Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aperius™ PercLID™ System', 'description': 'Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.'}, {'id': 'OG001', 'title': 'Standalone Decompressive Surgery', 'description': 'Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.'}], 'classes': [{'title': 'at 14 days', 'categories': [{'measurements': [{'value': '-67.62', 'spread': '35.57', 'groupId': 'OG000'}, {'value': '-57.64', 'spread': '35.70', 'groupId': 'OG001'}]}]}, {'title': 'at 6 weeks', 'categories': [{'measurements': [{'value': '-65.14', 'spread': '32.49', 'groupId': 'OG000'}, {'value': '-67.65', 'spread': '35.54', 'groupId': 'OG001'}]}]}, {'title': 'at 6 months', 'categories': [{'measurements': [{'value': '-56.10', 'spread': '37.97', 'groupId': 'OG000'}, {'value': '-66.75', 'spread': '34.62', 'groupId': 'OG001'}]}]}, {'title': 'At 12 months', 'categories': [{'measurements': [{'value': '-59.20', 'spread': '35.75', 'groupId': 'OG000'}, {'value': '-66.41', 'spread': '31.98', 'groupId': 'OG001'}]}]}, {'title': 'At 24 months', 'categories': [{'measurements': [{'value': '-70.71', 'spread': '34.44', 'groupId': 'OG000'}, {'value': '-66.55', 'spread': '31.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days, 6 weeks, 6 months, 12 months, and 24 months', 'description': 'Patients rated their leg pain using Visual Analog Scale (VAS) from 0 to 10, higher values represents a worse pain. Mean percentage change of VAS scores from baseline in leg pain is reported.', 'unitOfMeasure': 'percentage of change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).'}, {'type': 'SECONDARY', 'title': 'Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aperius™ PercLID™ System', 'description': 'Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.'}, {'id': 'OG001', 'title': 'Standalone Decompressive Surgery', 'description': 'Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.'}], 'classes': [{'title': 'percentage change of PCS at 14 days', 'categories': [{'measurements': [{'value': '35.93', 'spread': '50.06', 'groupId': 'OG000'}, {'value': '27.40', 'spread': '38.39', 'groupId': 'OG001'}]}]}, {'title': 'percentage change of PCS at 6 weeks', 'categories': [{'measurements': [{'value': '52.28', 'spread': '50.37', 'groupId': 'OG000'}, {'value': '46.16', 'spread': '42.02', 'groupId': 'OG001'}]}]}, {'title': 'percentage change of PCS at 6 months', 'categories': [{'measurements': [{'value': '53.95', 'spread': '53.04', 'groupId': 'OG000'}, {'value': '42.52', 'spread': '39.00', 'groupId': 'OG001'}]}]}, {'title': 'percentage change of PCS at 12 months', 'categories': [{'measurements': [{'value': '47.83', 'spread': '53.69', 'groupId': 'OG000'}, {'value': '44.82', 'spread': '37.77', 'groupId': 'OG001'}]}]}, {'title': 'percentage change of PCS at 24 months', 'categories': [{'measurements': [{'value': '51.53', 'spread': '49.37', 'groupId': 'OG000'}, {'value': '39.27', 'spread': '37.17', 'groupId': 'OG001'}]}]}, {'title': 'percentage change of MCS at 14 days', 'categories': [{'measurements': [{'value': '18.74', 'spread': '31.60', 'groupId': 'OG000'}, {'value': '23.42', 'spread': '39.98', 'groupId': 'OG001'}]}]}, {'title': 'percentage change of MCS at 6 weeks', 'categories': [{'measurements': [{'value': '25.27', 'spread': '35.05', 'groupId': 'OG000'}, {'value': '26.57', 'spread': '46.69', 'groupId': 'OG001'}]}]}, {'title': 'percentage change of MCS at 6 months', 'categories': [{'measurements': [{'value': '20.21', 'spread': '40.35', 'groupId': 'OG000'}, {'value': '25.90', 'spread': '44.57', 'groupId': 'OG001'}]}]}, {'title': 'percentage change of MCS at 12 months', 'categories': [{'measurements': [{'value': '18.21', 'spread': '34.86', 'groupId': 'OG000'}, {'value': '23.90', 'spread': '40.89', 'groupId': 'OG001'}]}]}, {'title': 'percentage change of MCS at 24 months', 'categories': [{'measurements': [{'value': '20.05', 'spread': '31.80', 'groupId': 'OG000'}, {'value': '21.74', 'spread': '40.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days, 6 weeks, 6 months, 12 months, and 24 months', 'description': 'The SF-36 questionnaire was used to assess the quality of life. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life. Mean percentage changes of SF-36 PCS and MCS from baseline are reported.', 'unitOfMeasure': 'percentage of change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Requiring Secondary Surgical Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aperius™ PercLID™ System', 'description': 'Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.'}, {'id': 'OG001', 'title': 'Standalone Decompressive Surgery', 'description': 'Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Overall study period, up to 24 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All patients who were operated within this study (either by an APERIUS® procedure or by SDS).'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Serious Adverse Device Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aperius™ PercLID™ System', 'description': 'Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.'}, {'id': 'OG001', 'title': 'Standalone Decompressive Surgery', 'description': 'Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Overall study period, up to 24 months', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All patients who were operated within this study (either by an APERIUS® procedure or by SDS).'}, {'type': 'SECONDARY', 'title': 'Changes in Stenosis of the Spinal Canal Assessed by Magnetic Resonance Imaging (MRI) at the Follow-up Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aperius™ PercLID™ System', 'description': 'Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.'}, {'id': 'OG001', 'title': 'Standalone Decompressive Surgery', 'description': 'Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.'}], 'classes': [{'title': 'First level operated at baseline (n=61, 62)', 'categories': [{'measurements': [{'value': '7.81', 'spread': '3.33', 'groupId': 'OG000'}, {'value': '8.20', 'spread': '2.97', 'groupId': 'OG001'}]}]}, {'title': 'First level operated at 12 months (n=53, 56)', 'categories': [{'measurements': [{'value': '9.55', 'spread': '3.61', 'groupId': 'OG000'}, {'value': '13.40', 'spread': '5.41', 'groupId': 'OG001'}]}]}, {'title': 'First level operated at 24 months (n=48, 49)', 'categories': [{'measurements': [{'value': '10.43', 'spread': '3.54', 'groupId': 'OG000'}, {'value': '13.80', 'spread': '5.32', 'groupId': 'OG001'}]}]}, {'title': 'Second level operated at baseline (n=28, 29)', 'categories': [{'measurements': [{'value': '7.30', 'spread': '2.91', 'groupId': 'OG000'}, {'value': '7.72', 'spread': '3.10', 'groupId': 'OG001'}]}]}, {'title': 'Second level operated at 12 months (n=26, 25)', 'categories': [{'measurements': [{'value': '9.44', 'spread': '4.45', 'groupId': 'OG000'}, {'value': '15.21', 'spread': '5.52', 'groupId': 'OG001'}]}]}, {'title': 'Second level operated at 24 months (n=21, 23)', 'categories': [{'measurements': [{'value': '10.20', 'spread': '4.94', 'groupId': 'OG000'}, {'value': '16.18', 'spread': '5.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 12 months, and 24 months', 'description': 'The lumen sizes of the spinal central canal were reported for the changes in stenosis of the spinal canal assessed by Magnetic Resonance Imaging (MRI) at the follow-up time points.', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).'}, {'type': 'SECONDARY', 'title': 'Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aperius™ PercLID™ System', 'description': 'Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.'}, {'id': 'OG001', 'title': 'Standalone Decompressive Surgery', 'description': 'Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.'}], 'classes': [{'title': 'First level operated at baseline', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'First level operated at 12 months', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'First level operated at 24 months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Second level operated at baseline', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Second level operated at 12 months', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Second level operated at 24 months', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline, 12 months, and 24 months', 'description': 'Number of subjects who had abnormal bony structure of Spinous process was reported for bony structure changes of Spinous process assessed by CT at the follow-up time points.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).'}, {'type': 'SECONDARY', 'title': 'Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-Back Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aperius™ PercLID™ System', 'description': 'Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.'}, {'id': 'OG001', 'title': 'Standalone Decompressive Surgery', 'description': 'Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.'}], 'classes': [{'title': 'First operated level at 12 months (n=49, 52)', 'categories': [{'measurements': [{'value': '-0.222', 'groupId': 'OG000'}, {'value': '-0.144', 'groupId': 'OG001'}]}]}, {'title': 'First operated level at 24 months (n=42, 39)', 'categories': [{'measurements': [{'value': '-0.013', 'groupId': 'OG000'}, {'value': '-0.229', 'groupId': 'OG001'}]}]}, {'title': 'Second operated level at 12 months (n=25, 20)', 'categories': [{'measurements': [{'value': '-0.200', 'groupId': 'OG000'}, {'value': '0.026', 'groupId': 'OG001'}]}]}, {'title': 'Second operated level at 24 months (n=17, 17)', 'categories': [{'measurements': [{'value': '0.029', 'groupId': 'OG000'}, {'value': '0.103', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months and 24 months', 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population analysis: all randomized patients who were operated, and had at least one post-operative assessment.'}, {'type': 'SECONDARY', 'title': 'Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-leg Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aperius™ PercLID™ System', 'description': 'Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.'}, {'id': 'OG001', 'title': 'Standalone Decompressive Surgery', 'description': 'Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.'}], 'classes': [{'title': 'First operated level at 12 months (n=49, 52)', 'categories': [{'measurements': [{'value': '-0.210', 'groupId': 'OG000'}, {'value': '-0.264', 'groupId': 'OG001'}]}]}, {'title': 'First operated level at 24 months (n=42, 39)', 'categories': [{'measurements': [{'value': '0.051', 'groupId': 'OG000'}, {'value': '-0.276', 'groupId': 'OG001'}]}]}, {'title': 'Second operated level at 12 months (n=25, 20)', 'categories': [{'measurements': [{'value': '0.181', 'groupId': 'OG000'}, {'value': '-0.050', 'groupId': 'OG001'}]}]}, {'title': 'Second operated level at 24 months (n=17, 17)', 'categories': [{'measurements': [{'value': '-0.065', 'groupId': 'OG000'}, {'value': '-0.287', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months and 24 months', 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population analysis: all randomized patients who were operated, and had at least one post-operative assessment.'}, {'type': 'SECONDARY', 'title': 'Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Physical Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aperius™ PercLID™ System', 'description': 'Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.'}, {'id': 'OG001', 'title': 'Standalone Decompressive Surgery', 'description': 'Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.'}], 'classes': [{'title': 'First level operated at 12 months (n=48, 50)', 'categories': [{'measurements': [{'value': '-0.179', 'groupId': 'OG000'}, {'value': '-0.242', 'groupId': 'OG001'}]}]}, {'title': 'First level operated at 24 months (n=41, 37)', 'categories': [{'measurements': [{'value': '0.193', 'groupId': 'OG000'}, {'value': '-0.163', 'groupId': 'OG001'}]}]}, {'title': 'Second operated level at 12 months (n=24, 20)', 'categories': [{'measurements': [{'value': '-0.016', 'groupId': 'OG000'}, {'value': '0.145', 'groupId': 'OG001'}]}]}, {'title': 'Second operated level at 24 months (n=17, 17)', 'categories': [{'measurements': [{'value': '0.173', 'groupId': 'OG000'}, {'value': '-0.104', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months and 24 months', 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population analysis: all randomized patients who were operated, and had at least one post-operative assessment.'}, {'type': 'SECONDARY', 'title': 'Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Symptom Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aperius™ PercLID™ System', 'description': 'Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.'}, {'id': 'OG001', 'title': 'Standalone Decompressive Surgery', 'description': 'Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.'}], 'classes': [{'title': 'First operated level at 12 months (n=48, 50)', 'categories': [{'measurements': [{'value': '-0.091', 'groupId': 'OG000'}, {'value': '-0.196', 'groupId': 'OG001'}]}]}, {'title': 'First operated level at 24 months (n=40, 37)', 'categories': [{'measurements': [{'value': '0.177', 'groupId': 'OG000'}, {'value': '-0.367', 'groupId': 'OG001'}]}]}, {'title': 'Second operated level at 12 months (n=24, 20)', 'categories': [{'measurements': [{'value': '0.114', 'groupId': 'OG000'}, {'value': '0.020', 'groupId': 'OG001'}]}]}, {'title': 'Second operated level at 24 months (n=16, 17)', 'categories': [{'measurements': [{'value': '-0.368', 'groupId': 'OG000'}, {'value': '-0.230', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months and 24 months', 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population analysis: all randomized patients who were operated, and had at least one post-operative assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aperius™ PercLID™ System', 'description': 'Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.'}, {'id': 'OG001', 'title': 'Standalone Decompressive Surgery', 'description': 'Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.'}], 'classes': [{'title': 'Improvement of symptoms at 14 days', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Improvement of symptoms at 6 weeks', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Improvement of symptoms at 6 months', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Improvement of symptoms at 12 months', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Improvement of symptoms at 24 months', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Symptom recurrence at 14 days', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Symptom recurrence at 6 weeks', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Symptom recurrence at 6 months', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Symptom recurrence at 12 months', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Symptom recurrence at 24 months', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Decreased therapeutic response at 14 days', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Decreased therapeutic response at 6 weeks', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Decreased therapeutic response at 6 months', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Decreased therapeutic response at 12 months', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Decreased therapeutic response at 24 months', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'No therapeutic response at 14 days', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'No therapeutic response at 6 weeks', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'No therapeutic response at 6 months', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'No therapeutic response at 12 months', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'No therapeutic response at 24 months', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Treatment failure at 14 days', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment failure at 6 weeks', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment failure at 6 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment failure at 12 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Treatment failure at 24 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 days, 6 weeks, 6 months, 12 months, and 24 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aperius™ PercLID™ System', 'description': 'Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.'}, {'id': 'FG001', 'title': 'Standalone Decompressive Surgery', 'description': 'Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': '12 Months Follow up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': '24 Months Follow up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aperius™ PercLID™ System', 'description': 'Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.'}, {'id': 'BG001', 'title': 'Standalone Decompressive Surgery', 'description': 'Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.29', 'spread': '10.91', 'groupId': 'BG000'}, {'value': '64.59', 'spread': '10.22', 'groupId': 'BG001'}, {'value': '64.94', 'spread': '10.55', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '28.54', 'spread': '3.50', 'groupId': 'BG000'}, {'value': '28.07', 'spread': '3.54', 'groupId': 'BG001'}, {'value': '28.31', 'spread': '3.51', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Per statistical analysis plan, populations excluded patients who withdrew consent during the study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 163}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-19', 'studyFirstSubmitDate': '2009-05-18', 'resultsFirstSubmitDate': '2016-04-28', 'studyFirstSubmitQcDate': '2009-05-19', 'lastUpdatePostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-06-17', 'studyFirstPostDateStruct': {'date': '2009-05-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Percentage Change From Baseline in Physical Function at 1 Year Follow-up Using the Patient Completed Zurich Claudication Questionnaire', 'timeFrame': '1 year', 'description': 'ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: Physical function (PF), Symptom Severity (SS), and post-treatment Patient Satisfaction (PS).PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. Mean percentage change from baseline in Physical Function at 1 year follow-up was reported.'}], 'secondaryOutcomes': [{'measure': 'Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire', 'timeFrame': '14 days, 6 weeks, 6 months, and 24 months', 'description': 'ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: Physical function (PF), Symptom Severity (SS), and post-treatment Patient Satisfaction (PS).PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. Mean percentage change from baseline in Physical Function at 14 days, 6 weeks, 6 months, and 24 months was reported.'}, {'measure': 'Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire', 'timeFrame': '14days, 6 week, 6 months, 12 months, 24 months', 'description': 'ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment PS. SS Score is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance) in ZCQ. 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 1 to 5. A lower score represents a better outcome/condition. Mean percentage of change from baseline in Symptom Severity is reported.'}, {'measure': 'Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire', 'timeFrame': '14 days, 6 weeks, 6 months, 12 months, and 24 months', 'description': 'PS score is the mean score of 6 questions of ZCQ, ranging from 1 to 4 if the number of responses exceeded four. A lower score represents a better outcome. Patients with PS score less than 2.5 at postoperative evaluation were considered positive, which implied that patients were satisfied with their treatment.'}, {'measure': 'Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain', 'timeFrame': '14 days, 6 weeks, 6 months, 12 months, and 24 months', 'description': 'Patients rated their leg pain using Visual Analog Scale (VAS) from 0 to 10, higher values represents a worse pain. Mean percentage change of VAS scores from baseline in leg pain is reported.'}, {'measure': 'Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire', 'timeFrame': '14 days, 6 weeks, 6 months, 12 months, and 24 months', 'description': 'The SF-36 questionnaire was used to assess the quality of life. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life. Mean percentage changes of SF-36 PCS and MCS from baseline are reported.'}, {'measure': 'Number of Subjects Requiring Secondary Surgical Intervention', 'timeFrame': 'Overall study period, up to 24 months'}, {'measure': 'Percentage of Subjects With Serious Adverse Device Effects', 'timeFrame': 'Overall study period, up to 24 months'}, {'measure': 'Changes in Stenosis of the Spinal Canal Assessed by Magnetic Resonance Imaging (MRI) at the Follow-up Time Points', 'timeFrame': 'baseline, 12 months, and 24 months', 'description': 'The lumen sizes of the spinal central canal were reported for the changes in stenosis of the spinal canal assessed by Magnetic Resonance Imaging (MRI) at the follow-up time points.'}, {'measure': 'Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points', 'timeFrame': 'baseline, 12 months, and 24 months', 'description': 'Number of subjects who had abnormal bony structure of Spinous process was reported for bony structure changes of Spinous process assessed by CT at the follow-up time points.'}, {'measure': 'Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-Back Pain', 'timeFrame': '12 months and 24 months'}, {'measure': 'Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-leg Pain', 'timeFrame': '12 months and 24 months'}, {'measure': 'Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Physical Function', 'timeFrame': '12 months and 24 months'}, {'measure': 'Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Symptom Severity', 'timeFrame': '12 months and 24 months'}, {'measure': 'Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months', 'timeFrame': '14 days, 6 weeks, 6 months, 12 months, and 24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Spinal Stenosis']}, 'descriptionModule': {'briefSummary': 'The objective of the NICE study is to provide clinical evidence proving that the Aperius™ PercLID™ System is safe and non-inferior to standalone decompressive surgery with regards to clinical outcomes in patients suffering from Degenerative Lumbar Spinal Stenosis with Neurogenic Intermittent Claudication, relieved by flexion.', 'detailedDescription': 'The NICE study is a Multicenter Prospective Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of the Aperius™ PercLID™System Versus Standalone Decompressive Surgery in Degenerative Lumbar Spinal Stenosis with Neurogenic Intermittent Claudication.\n\nDLSS patients suffering from NIC that would be candidates for surgical treatment without stabilization and/or fusion can be offered participation in the study. After randomization, patients will be treated with either the Aperius™ PercLID™ System or Standalone Decompressive Surgery (SDS). A sample size recalculation reduced the amount of patients to be enrolled from 280 to 128 in both treatment group.\n\nThe patient will undergo a study visit at screening / baseline and at 14 days, 6 weeks, 6, 12 and 24 months after surgery. Safety data will be collected during surgery and throughout the 24 months follow up. Procedural details will be collected during surgery and also duration of hospital stay will be collected. At screening / baseline and all follow up visits a physical examination will be performed, the use of pain medication will be documented and the subject will be asked to complete a pain VAS scale (back - leg - buttock / groin pain) and questionnaires (SF36 v2 and Zurich Claudication Questionnaire).\n\nStudy subjects are required to undergo X-ray, CT and MRI and fluoroscopy procedures at specified time points during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of symptomatic DLSS\n* Presence of NIC\n* Patient would be candidate for Standalone Decompressive Surgery\n* Patient has signed Informed Consent form (ICF)\n* Patient is 21 years old or older\n\nExclusion Criteria:\n\n* Previous lumbar surgery\n* Patient is candidate for instrumented Decompressive Surgery\n* Patient has back pain without leg pain\n* Degenerative Spondylolisthesis greater than grade 1 (Meyerding)\n* Symptomatic DLSS at more than 2 levels in the lumbar region\n* Spinal stenosis is present at L5-S1 level'}, 'identificationModule': {'nctId': 'NCT00905359', 'acronym': 'NICE', 'briefTitle': 'Neurogenic Intermittent Claudication Evaluation Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Spinal and Biologics'}, 'officialTitle': 'A Multicenter Prospective Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of the Aperius™ PercLID™ System Versus Standalone Decompressive Surgery in Degenerative Lumbar Spinal Stenosis With Neurogenic Intermittent Claudication', 'orgStudyIdInfo': {'id': 'CIP 0002 AP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aperius™ PercLID™ System', 'description': 'Aperius™ PercLID™ System arm. Patients randomized to this arm will undergo treatment with the Aperius™ PercLID™ System.', 'interventionNames': ['Procedure: Aperius™ PercLID™ System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standalone Decompressive Surgery', 'description': 'Patients randomized to this arm will receive Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.', 'interventionNames': ['Procedure: Standalone Decompressive Surgery']}], 'interventions': [{'name': 'Aperius™ PercLID™ System', 'type': 'PROCEDURE', 'description': 'Aperius™ PercLID™ System: implantation with the Interspinous Process Device Aperius.', 'armGroupLabels': ['Aperius™ PercLID™ System']}, {'name': 'Standalone Decompressive Surgery', 'type': 'PROCEDURE', 'description': 'Lumbar decompressive surgery without instrumentation or fusion', 'armGroupLabels': ['Standalone Decompressive Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4217', 'city': 'Benowa', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Pindara Specialist Suite', 'geoPoint': {'lat': -28.0077, 'lon': 153.38583}}, {'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'Ziekenhuis St. Jan - Orthopedie', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '1040', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Clinique Parc Leopold - Neurochirurgie', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '7100', 'city': 'La Louvière', 'country': 'Belgium', 'facility': 'CHU Tivoli - Neurochirurgie', 'geoPoint': {'lat': 50.48657, 'lon': 4.18785}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Clinique Saint Joseph - Neurochirurgie', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '7301', 'city': 'Mons', 'country': 'Belgium', 'facility': 'Centre hospitalier du Grand Hornu - Orthopédie / Traumatologie', 'geoPoint': {'lat': 50.45413, 'lon': 3.95229}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Centre Universitaire Pellegrin Tripode -Orthopédie-Traumatologie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Roger Salengro - Clinique de Neurochirurgie', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '06002', 'city': 'Nice', 'country': 'France', 'facility': 'CHU de Nice Hôpital Pasteur - Neurochirurgie', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Neurochirurgische Klinik - Campus Benjamin Franklin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '81675', 'city': 'München', 'country': 'Germany', 'facility': 'Klinikum rechts der Isar der TU München - Neurochirurgie', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '108', 'city': 'Reykjavik', 'country': 'Iceland', 'facility': 'Landspitali - National hospital of Iceland', 'geoPoint': {'lat': 64.13548, 'lon': -21.89541}}, {'zip': '00189', 'city': 'Rome', 'country': 'Italy', 'facility': "Azienda Ospedaliera Sant'Andrea - Neurochirurgia", 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '21100', 'city': 'Varese', 'country': 'Italy', 'facility': 'Ospedale di Circolo - Ortopedia e Traumatologia', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'city': 'Torun', 'country': 'Poland', 'facility': 'Municipal Hospital - Szpital Miejski', 'geoPoint': {'lat': 53.01375, 'lon': 18.59814}}, {'zip': '02-005', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Szpital Kliniczny Dziecatka Jezus - Orthopaedics', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '169608', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Singapore General Hospital - Orthopaedic Surgery', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Ortopedmottagningen SU/Sahlgrenska', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': 'AB15 6ZQ', 'city': 'Aberdeen', 'country': 'United Kingdom', 'facility': 'Woodend Hospital - Department of Orthopaedics', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}], 'overallOfficials': [{'name': 'Jean-Charles Le Huec, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Pellegrin Tripode'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Spinal and Biologics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}