Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-29 @ 10:33 PM
Study NCT ID:
NCT00854295
Status:
COMPLETED
Last Update Posted:
2023-02-14
First Post:
2009-02-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D056304', 'term': 'Genu Valgum'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D010020', 'term': 'Osteonecrosis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'erin.osborn@zimmerbiomet.com', 'phone': '574-371-9884', 'title': 'Erin Osborn', 'organization': 'Zimmer Biomet'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Group 2 (PAS Group) - Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year. Group 1 (Subjects in the previous IDE study who were eligible to participate in the PAS) - 4 year, 5 year, 6 year, 8 year, and 10 year', 'eventGroups': [{'id': 'EG000', 'title': 'LPS Flex Mobile Unilateral (Group 2)', 'description': 'Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in one knee were in the Unilateral Group.', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 82, 'seriousNumAtRisk': 106, 'deathsNumAffected': 7, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'LPS Flex Mobile Bilateral (Group 2)', 'description': 'Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in two knees were in the Bilateral Group.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'LPS Flex Fixed (Group 1)', 'description': 'Subjects in this group received the LPS-Flex Fixed Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 64, 'seriousNumAtRisk': 77, 'deathsNumAffected': 1, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'LPS Flex Mobile (Group 1)', 'description': 'Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 14, 'seriousNumAtRisk': 69, 'deathsNumAffected': 1, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'ACUTE BLOOD LOSS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ADHESIVE CAPSULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ALLERGIC REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ALZHEIMERS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ANEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ANKLE FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ANKLE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ANKLE TENDINITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AORTIC ANEURYSM VALVE REPLACEMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ARTHRALGIA SHOULDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BACK INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BENIGN MOLE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BICEP TEAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BICEP TENDON STRAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BLADDER INCONTINENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BLISTERS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BREAST CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BRONCHITITS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BURNING IN LEGS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BURSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BUTTOCKS BRUISE FROM FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BUTTOCKS PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CALF PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CALF STIFFNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CARDIAC ARRHYTHMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CARPAL TUNNEL SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CARPOMETACARPAL ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CATARACT SURGERY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CHOLECYSTECTOMY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CHONDROMALACIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CHRONIC BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CLL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CONGESTIVE HEART FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CONTACT DERMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CREPITATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DEGENERATIVE DISC DISEASE', 'stats': 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{'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CARDIAC BYPASS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'KNEE ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'KNEE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HIP PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'STROKE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TIBIAL COMPONENT LOOSENING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Group 2 - Total Knee Society Score (KSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LPS Flex Mobile Unilateral Group (Group 2)', 'description': 'Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in one knee were in the Unilateral Group.'}, {'id': 'OG001', 'title': 'LPS Flex Mobile Bilateral Group (Group 2)', 'description': 'Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in two knees were in the Bilateral Group.'}], 'classes': [{'title': 'Pre-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92.2', 'spread': '28.5', 'groupId': 'OG000'}, {'value': '78.5', 'spread': '29', 'groupId': 'OG001'}]}]}, {'title': '6 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '118.2', 'spread': '33', 'groupId': 'OG000'}, {'value': '96.7', 'spread': '34', 'groupId': 'OG001'}]}]}, {'title': '6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '148', 'spread': '29.7', 'groupId': 'OG000'}, {'value': '130.4', 'spread': '51.5', 'groupId': 'OG001'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '159.2', 'spread': '28.1', 'groupId': 'OG000'}, {'value': '137.2', 'spread': '56.9', 'groupId': 'OG001'}]}]}, {'title': '2 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '159.2', 'spread': '32.2', 'groupId': 'OG000'}, {'value': '149.4', 'spread': '34.7', 'groupId': 'OG001'}]}]}, {'title': '3 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '161.1', 'spread': '27.3', 'groupId': 'OG000'}, {'value': '147.3', 'spread': '45.3', 'groupId': 'OG001'}]}]}, {'title': '4 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '160.2', 'spread': '29.4', 'groupId': 'OG000'}, {'value': '121.3', 'spread': '56.7', 'groupId': 'OG001'}]}]}, {'title': '5 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '160.8', 'spread': '28.6', 'groupId': 'OG000'}, {'value': '167.1', 'spread': '29.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year', 'description': 'Total Knee Society Score is used to assess pain and function which is scored from 0 to 200 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with an evaluable endpoint at each time frame interval were used to calculate mean and standard deviations.'}, {'type': 'PRIMARY', 'title': 'Group 2 - Number of Subjects With Absence of Radiolucency/Bone Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LPS Flex Mobile Unilateral Group (Group 2)', 'description': 'Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in one knee were in the Unilateral Group.'}, {'id': 'OG001', 'title': 'LPS Flex Mobile Bilateral Group (Group 2)', 'description': 'Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in two knees were in the Bilateral Group.'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 year', 'description': 'Independent radiographic was performed on all required post-operative follow-up intervals and a detailed report was provided at the completion of the study. Each case was expected to have anteroposterio (A/P) and lateral radiographs obtained at all postoperative assessments. An independent review of the radiographs was assessed for progressive radiolucencies over time. Per the protocol, radiographic outcomes are defined as "An absence of subsidence of greater than or equal to 2 millimeters and an absence of both osteolysis and radiolucencies greater than or equal to 2 millimeters as determined by an independent radiographic reviewer."', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with an evaluable endpoint at the applicable time frame interval were used to calculate the count of participants.'}, {'type': 'PRIMARY', 'title': 'Group 2 - Number of Subjects With Absence of Implant Revision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LPS Flex Mobile Unilateral Group (Group 2)', 'description': 'Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in one knee were in the Unilateral Group.'}, {'id': 'OG001', 'title': 'LPS Flex Mobile Bilateral Group (Group 2)', 'description': 'Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in two knees were in the Bilateral Group.'}], 'classes': [{'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 year', 'description': 'Revision is defined as "No intended, actual, or planned removal of any component of the knee system."', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with an evaluable endpoint at the applicable time frame interval were used to calculate the count of participants.'}, {'type': 'PRIMARY', 'title': 'Group 2 - Number of Subjects With Absence of Severe Knee-Related Complication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LPS Flex Mobile Unilateral Group (Group 2)', 'description': 'Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in one knee were in the Unilateral Group.'}, {'id': 'OG001', 'title': 'LPS Flex Mobile Bilateral Group (Group 2)', 'description': 'Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in two knees were in the Bilateral Group.'}], 'classes': [{'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 year', 'description': 'All severe knee-related complications are determined by each study investigator. A severe adverse event is any undesirable experience associated with the use of the implant in a patient that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a birth defect. A knee-related complication is an adverse event that has been classified by the investigator to have a relation to the knee.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with an evaluable endpoint at the applicable time frame interval were used to calculate the count of participants.'}, {'type': 'PRIMARY', 'title': 'Group 1 - Total Knee Society Score (KSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LPS Flex Fixed (Group 1)', 'description': 'Subjects in this group received the LPS-Flex Fixed Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.'}, {'id': 'OG001', 'title': 'LPS Flex Mobile (Group 1)', 'description': 'Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee. Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in both knees. Subjects in this group received the LPS-Flex Fixed Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study. Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.'}], 'classes': [{'title': '4 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '164.6', 'spread': '32.9', 'groupId': 'OG000'}, {'value': '184.4', 'spread': '9.7', 'groupId': 'OG001'}]}]}, {'title': '5 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '142.4', 'spread': '32.2', 'groupId': 'OG000'}, {'value': '142.6', 'spread': '41.3', 'groupId': 'OG001'}]}]}, {'title': '6 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '161.9', 'spread': '28.1', 'groupId': 'OG000'}, {'value': '169.3', 'spread': '29.8', 'groupId': 'OG001'}]}]}, {'title': '8 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '164.8', 'spread': '31.0', 'groupId': 'OG000'}, {'value': '172.0', 'spread': '26.9', 'groupId': 'OG001'}]}]}, {'title': '10 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '166.6', 'spread': '25.5', 'groupId': 'OG000'}, {'value': '170.8', 'spread': '29.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 year, 5 year, 6 year, 8 year, and 10 year', 'description': 'Total Knee Society Score is used to assess pain and function which is scored from 0 to 200 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with an evaluable endpoint at each time frame interval were used to calculate mean and standard deviations.'}, {'type': 'PRIMARY', 'title': 'Group 1 - Number of Subjects With Absence of Radiolucency/Bone Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LPS Flex Fixed (Group 1)', 'description': 'Subjects in this group received the LPS-Flex Fixed Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.'}, {'id': 'OG001', 'title': 'LPS Flex Mobile (Group 1)', 'description': 'Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 year', 'description': 'Independent radiographic was performed on all required post-operative follow-up intervals and a detailed report was provided at the completion of the study. Each case was expected to have anteroposterio (A/P) and lateral radiographs obtained at all postoperative assessments. An independent review of the radiographs was assessed for progressive radiolucencies over time. Per the protocol, radiographic outcomes are defined as "An absence of subsidence of greater than or equal to 2 millimeters and an absence of both osteolysis and radiolucencies greater than or equal to 2 millimeters as determined by an independent radiographic reviewer."', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with an evaluable endpoint at the applicable time frame interval were used to calculate the count of participants.'}, {'type': 'PRIMARY', 'title': 'Group 1 - Number of Subjects With Absence of Implant Revision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LPS Flex Fixed (Group 1)', 'description': 'Subjects in this group received the LPS-Flex Fixed Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.'}, {'id': 'OG001', 'title': 'LPS Flex Mobile (Group 1)', 'description': 'Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 year', 'description': 'Revision is defined as "No intended, actual, or planned removal of any component of the knee system."', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with an evaluable endpoint at the applicable time frame interval were used to calculate the count of participants.'}, {'type': 'PRIMARY', 'title': 'Group 1 - Number of Subjects With Absence of Severe Knee-Related Complication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LPS Flex Fixed (Group 1)', 'description': 'Subjects in this group received the LPS-Flex Fixed Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.'}, {'id': 'OG001', 'title': 'LPS Flex Mobile (Group 1)', 'description': 'Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 year', 'description': 'All severe knee-related complications are determined by each study investigator. A severe adverse event is any undesirable experience associated with the use of the implant in a patient that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a birth defect. A knee-related complication is an adverse event that has been classified by the investigator to have a relation to the knee.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with an evaluable endpoint at the applicable time frame interval were used to calculate the count of participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LPS Flex Mobile Unilateral Group (Group 2)', 'description': 'Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee.'}, {'id': 'FG001', 'title': 'LPS Flex Mobile Bilateral Group (Group 2)', 'description': 'Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in both knees.'}, {'id': 'FG002', 'title': 'LPS Flex Fixed (Group 1)', 'description': 'Subjects in this group received the LPS-Flex Fixed Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.'}, {'id': 'FG003', 'title': 'LPS Flex Mobile (Group 1)', 'description': 'Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '77'}, {'groupId': 'FG003', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '21'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeons experienced in primary total knee replacement. Subjects who had one operative knee were in the Unilateral Group and subjects who had two operative knees were in the Bilateral Group. These subjects are considered "Group 2" per the study protocol.', 'preAssignmentDetails': 'All cases in "Group 1" per the protocol (subjects in the previous IDE study who were eligible to participate in the PAS) have study completed and are not included in these results. A final report for Group 1 was previously approved by FDA on June 29, 2016. Since 2016, only data from Group 2 subjects (PAS Group) was reported to FDA and are applicable to this clinicatrials.gov record.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}, {'value': '266', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'LPS Flex Mobile Uniliteral (Group 2)', 'description': 'Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in one knee were in the Unilateral Group.'}, {'id': 'BG001', 'title': 'LPS Flex Mobile Bilateral (Group 2)', 'description': 'Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in two knees were in the Bilateral Group.'}, {'id': 'BG002', 'title': 'LPS Flex Fixed (Group 1)', 'description': 'Subjects in this group received the LPS-Flex Fixed Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.'}, {'id': 'BG003', 'title': 'LPS Flex Mobile (Group 1)', 'description': 'Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.8', 'groupId': 'BG000', 'lowerLimit': '45', 'upperLimit': '85'}, {'value': '62.4', 'groupId': 'BG001', 'lowerLimit': '52', 'upperLimit': '72'}, {'value': '61.4', 'groupId': 'BG002', 'lowerLimit': '35', 'upperLimit': '81'}, {'value': '62.5', 'groupId': 'BG003', 'lowerLimit': '34', 'upperLimit': '80'}, {'value': '65.4', 'groupId': 'BG004', 'lowerLimit': '45', 'upperLimit': '85'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '171', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}, {'value': '239', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}, {'value': '266', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-08-06', 'size': 524213, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-12-15T16:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 266}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-18', 'studyFirstSubmitDate': '2009-02-26', 'resultsFirstSubmitDate': '2022-02-22', 'studyFirstSubmitQcDate': '2009-02-27', 'lastUpdatePostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-18', 'studyFirstPostDateStruct': {'date': '2009-03-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Group 2 - Total Knee Society Score (KSS)', 'timeFrame': 'Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year', 'description': 'Total Knee Society Score is used to assess pain and function which is scored from 0 to 200 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.'}, {'measure': 'Group 2 - Number of Subjects With Absence of Radiolucency/Bone Loss', 'timeFrame': '5 year', 'description': 'Independent radiographic was performed on all required post-operative follow-up intervals and a detailed report was provided at the completion of the study. Each case was expected to have anteroposterio (A/P) and lateral radiographs obtained at all postoperative assessments. An independent review of the radiographs was assessed for progressive radiolucencies over time. Per the protocol, radiographic outcomes are defined as "An absence of subsidence of greater than or equal to 2 millimeters and an absence of both osteolysis and radiolucencies greater than or equal to 2 millimeters as determined by an independent radiographic reviewer."'}, {'measure': 'Group 2 - Number of Subjects With Absence of Implant Revision', 'timeFrame': '5 year', 'description': 'Revision is defined as "No intended, actual, or planned removal of any component of the knee system."'}, {'measure': 'Group 2 - Number of Subjects With Absence of Severe Knee-Related Complication', 'timeFrame': '5 year', 'description': 'All severe knee-related complications are determined by each study investigator. A severe adverse event is any undesirable experience associated with the use of the implant in a patient that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a birth defect. A knee-related complication is an adverse event that has been classified by the investigator to have a relation to the knee.'}, {'measure': 'Group 1 - Total Knee Society Score (KSS)', 'timeFrame': '4 year, 5 year, 6 year, 8 year, and 10 year', 'description': 'Total Knee Society Score is used to assess pain and function which is scored from 0 to 200 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.'}, {'measure': 'Group 1 - Number of Subjects With Absence of Radiolucency/Bone Loss', 'timeFrame': '10 year', 'description': 'Independent radiographic was performed on all required post-operative follow-up intervals and a detailed report was provided at the completion of the study. Each case was expected to have anteroposterio (A/P) and lateral radiographs obtained at all postoperative assessments. An independent review of the radiographs was assessed for progressive radiolucencies over time. Per the protocol, radiographic outcomes are defined as "An absence of subsidence of greater than or equal to 2 millimeters and an absence of both osteolysis and radiolucencies greater than or equal to 2 millimeters as determined by an independent radiographic reviewer."'}, {'measure': 'Group 1 - Number of Subjects With Absence of Implant Revision', 'timeFrame': '10 year', 'description': 'Revision is defined as "No intended, actual, or planned removal of any component of the knee system."'}, {'measure': 'Group 1 - Number of Subjects With Absence of Severe Knee-Related Complication', 'timeFrame': '10 year', 'description': 'All severe knee-related complications are determined by each study investigator. A severe adverse event is any undesirable experience associated with the use of the implant in a patient that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a birth defect. A knee-related complication is an adverse event that has been classified by the investigator to have a relation to the knee.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['arthritis', 'osteoarthritis', 'degenerative knee disease', 'avascular necrosis', 'total knee replacement', 'TKA'], 'conditions': ['Osteoarthritis', 'Traumatic Arthritis', 'Avascular Necrosis of the Femoral Condyle', 'Moderate Varus', 'Valgus', 'Flexion Deformities']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the long-term performance of the NexGen LPS-Flex Mobile Bearing Knee in the treatment of patients with severe knee pain or degenerative knee disease.', 'detailedDescription': 'The NexGen LPS-FLex Mobile Bearing Knee received FDA approval for commercial distribution in the US on December 10, 2007. The approval was in accordance with a "condition of approval" to perform a 10-year post approval study to evaluate the longer-term safety and effectiveness of the LPS-Flex Mobile Bearing Knee. The post approval study will consist of patients from the investigational device exemption study arm (Group 1) as well as patients who are eligible for a total knee replacement and have been chosen to receive the LPS-Flex Mobile Knee (Group 2). Group 1 will be followed from 4 years through a total of 10 years from the date of surgery. Group 2 will be followed from pre-op through a total of 5 years from the date of surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Osteoarthritis\n* Primary and secondary traumatic arthritis\n* Avascular necrosis of the femoral condyle\n* Moderate varus, valgus, or flexion deformities (i.e. valgus/varus deformity of less than or equal to 15 degrees, fixed flexion deformity of less than or equal to 10 degrees)\n\nExclusion Criteria:\n\n* Previous history of infection in the affected joint and/or local/systemic infection that may affect the prosthetic joint\n* Insufficient bone stock on femoral or tibial surfaces\n* Skeletal immaturity\n* Neuropathic arthropathy\n* Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb\n* A stable, painless arthrodesis in a satisfactory functional position\n* Severe instability secondary to the absence of collateral integrity\n* Total knee arthroplasty is contraindicated in patients who have rheumatoid arthritis (RA) and an ulcer of the skin or a history of recurrent breakdown of the skin because their risk of postoperative infection is greater. RA patient using steroids may also have increased risk of infection. Late infections in RA patients have been reported 24+ months postoperative.\n* Patient is a poor compliance risk, i.e., history of ethanol or drug abuse, or mental handicap that would compromise patient compliance with respect to rehabilitation or follow-up\n* Patient is not willing or able to give informed consent to participate in the follow-up program\n* Patient is not willing to return for all scheduled follow-up appointments as defined by this protocol.'}, 'identificationModule': {'nctId': 'NCT00854295', 'briefTitle': 'Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee', 'orgStudyIdInfo': {'id': '07-100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Post-Approval Study Group (Group 2)', 'description': 'Subjects enrolled in a short-term study (5 years) consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by orthopedic surgeons experienced in primary total knee replacement. All Group 2 subjects, both unilateral and bilateral subjects, are in the same arm of the study. As part of the PAS study, these subjects were followed from Pre-operative to 5 years.', 'interventionNames': ['Device: NexGen LPS-Flex Mobile Bearing Knee']}, {'type': 'EXPERIMENTAL', 'label': 'Investigational Device Exemption Group (Group 1)', 'description': 'Subjects who were implanted with either the LPS Flex Fixed Bearing Knee (control population) or the LPS Flex Mobile Bearing Knee device during the previous Investigational Device Exemption study. As part of the PAS study, these subjects were followed from 4 years to 10 years.', 'interventionNames': ['Device: NexGen LPS-Flex Mobile Bearing Knee']}], 'interventions': [{'name': 'NexGen LPS-Flex Mobile Bearing Knee', 'type': 'DEVICE', 'otherNames': ['Mobile bearing knee'], 'description': 'Total Knee Replacement', 'armGroupLabels': ['Investigational Device Exemption Group (Group 1)', 'Post-Approval Study Group (Group 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33321', 'city': 'Tamarac', 'state': 'Florida', 'country': 'United States', 'facility': 'Phoenix Clinical Research', 'geoPoint': {'lat': 26.21286, 'lon': -80.24977}}, {'zip': '48236-2776', 'city': 'Auburn Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Advanced Orthopaedics', 'geoPoint': {'lat': 42.68753, 'lon': -83.2341}}, {'zip': '37923', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Orthopaedic Foundation for Education and Research', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}], 'overallOfficials': [{'name': 'Erin Osborn', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zimmer Biomet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}