Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT00289133
Status:
COMPLETED
Last Update Posted:
2017-04-24
First Post:
2006-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Gamma Vacuum Foil (GVF) Versus Cross-linked Polyethylene in Total Knee Arthroplasty Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shimden@its.jnj.com', 'phone': '574-372-7231', 'title': 'Clinical Portfolio Leader', 'organization': 'DePuy Orthopaedics, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "Serious adverse events were not collected in this study per the modern definition. All adverse events collected for this study will be reported in the 'Other Adverse Events' table. MedDRA was used to classify each AE into SOC, but not Preferred Term."}}, 'adverseEventsModule': {'timeFrame': 'Intraoperatively and postoperatively through 6 years.', 'description': 'Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.', 'eventGroups': [{'id': 'EG000', 'title': 'GVF Poly', 'description': 'Gamma Vacuum Foil polyethylene tibial component', 'otherNumAtRisk': 461, 'otherNumAffected': 146, 'seriousNumAtRisk': 461, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'XLK Poly', 'description': 'Cross-linked polyethylene tibial component', 'otherNumAtRisk': 477, 'otherNumAffected': 164, 'seriousNumAtRisk': 477, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other-Syncope Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 17, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 14, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Central Nervous System', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other-Positive Nasal Culture for MRSA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Wound Problem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Endocrine/Metabolic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Central Nervous System', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Endocrine/Metabolic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Extensor Mechanism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 68, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 87, 'numAffected': 37}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other- Feeling of Instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other-Follow-up right knee arthroscope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other- Grade 1 Strain Medial Collateral Ligament', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': "Other-Inflamed bursa over Gerdy's Tubercle", 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other-Mild Limp Secondary to Stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other- Patella Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other- Patella Clunk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other- Pes Bursitis; ITB syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other- Pesanserinus Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other- Pre Patellar Bursitis with Peri Patellar tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other- Routine F/U to Bilateral knee arthroscopic debulking', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other- F/U Right Knee Arthroscope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'other- Right Ankle Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other- Subject has continuous right knee pain (non-surgical knee)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other- Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Central Nervous System', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Peripheral Nervous System', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Respiratory System', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other- Dermis Contact Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other- Itchy Red Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other- Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other- Skin Rash on Low Bilateral Legs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Wound Problem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other- Change in Insurance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Peri-op AE - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Thrombosis/Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Stiffness, Arthrofibrosis, Ankylosis, Limited Range of Motion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other - Systemic: Voluntary Withdrawal', 'notes': 'Reason not specified; Surgical Site not specified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Endocrine/Metabolic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Central Nervous System', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 34, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Wound Problem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hematological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hematological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': "Other - Advanced Alzheimer's", 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other - Radiographic subsidence of the femoral component - asymptomatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Extensor Mechanism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other - Left knee artrhoscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other - Atraumatic onset of right buttock pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hemarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other - 20 degree flexion contracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other - Bilateral knee pain', 'notes': 'Right knee pain greater than left knee pain; Arthroscope 2 months post-op', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other - Bilateral hand numbness and pain', 'notes': 'Carpal Tunnel Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other - Fell and injured quad', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Death', 'notes': 'Unknown Cause', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Death', 'notes': 'Complications from Septic Shock due to Necrotic Gallbladder and Bowel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other - Had fall and fractured left shoulder and had a concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other - Flexion Instability', 'notes': 'Revision of right total knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other - Left Hip Revision', 'notes': 'Underwent Total Hip Replacement after Breaking Hip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other - Severe Low Back Pain', 'notes': 'Led to Neurological Deficit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other - Death', 'notes': 'Unknown Cause', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other - Ovarian Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other - Stage 4 Terminal Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other - Stage 4 Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other - Death', 'notes': "From Respiratory Complications and Parkinson's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other - Death', 'notes': 'Reported Suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other - Follow-up Left Knee Arthroscope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other - Glioblastoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Other - Fall Injured Quad Repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Loosening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Central Nervous System', 'stats': [{'groupId': 'EG000', 'numAtRisk': 461, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 477, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Survivorship (Revision of Any Component for Any Reason)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}, {'units': 'number of knees', 'counts': [{'value': '402', 'groupId': 'OG000'}, {'value': '422', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GVF Poly', 'description': 'Gamma Vacuum Foil polyethylene tibial insert total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert'}, {'id': 'OG001', 'title': 'XLK Poly', 'description': 'Cross-linked polyethylene tibial insert total knee arthroplasty: cross-linked polyethylene tibial insert'}], 'classes': [{'categories': [{'measurements': [{'value': '96.8', 'groupId': 'OG000', 'lowerLimit': '93.9', 'upperLimit': '98.4'}, {'value': '98.1', 'groupId': 'OG001', 'lowerLimit': '95.6', 'upperLimit': '99.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Survival was estimated by Kaplan-Meier method. Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.', 'unitOfMeasure': 'percentage of knees', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of knees', 'denomUnitsSelected': 'number of knees', 'populationDescription': 'Survivorship can only be calculated on knees (not participants as some study subjects had bilateral knees in the study) with post-operative follow-up. 35 knees were excluded due to post-operative follow-up not being available. 67 knees were excluded due to protocol violations.'}, {'type': 'SECONDARY', 'title': 'American Knee Society Evaluation - Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}, {'units': 'Knees', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GVF Poly', 'description': 'Gamma Vacuum Foil polyethylene'}, {'id': 'OG001', 'title': 'XLK Poly', 'description': 'Cross-linked polyethylene'}], 'classes': [{'categories': [{'measurements': [{'value': '94.7', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '93.5', 'spread': '9.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 year', 'description': 'American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Knees', 'denomUnitsSelected': 'Knees', 'populationDescription': 'The number of knees analyzed was the number available for analysis at this post-operative timepoint.'}, {'type': 'SECONDARY', 'title': 'American Knee Society Evaluation - Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}, {'units': 'Knees', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GVF Poly', 'description': 'Gamma Vacuum Foil polyethylene tibial component'}, {'id': 'OG001', 'title': 'XLK Poly', 'description': 'Cross-linked polyethylene tibial component'}], 'classes': [{'categories': [{'measurements': [{'value': '93.5', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '93.1', 'spread': '8.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Minimum 5 years, up to 7.6 years', 'description': 'American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Knees', 'denomUnitsSelected': 'Knees', 'populationDescription': 'The number of knees analyzed was the number available for analysis at this post-operative timepoint.'}, {'type': 'SECONDARY', 'title': 'Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}, {'units': 'Knees', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GVF Poly', 'description': 'Gamma Vacuum Foil polyethylene'}, {'id': 'OG001', 'title': 'XLK Poly', 'description': 'Cross-linked polyethylene'}], 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '15.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 year', 'description': 'WOMAC is a patient reported outcome (PRO) that evaluates the condition of subjects with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint. The total score ranged from 0 to 96. The subscales are combined (summed) to compute a total score, where a lower score indicates a better outcome.', 'unitOfMeasure': 'scores (points) on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Knees', 'denomUnitsSelected': 'Knees', 'populationDescription': 'The number of knees analyzed was the number available for analysis at this post-operative timepoint.'}, {'type': 'SECONDARY', 'title': 'Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}, {'units': 'Knees', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GVF Poly', 'description': 'Gamma Vacuum Foil polyethylene'}, {'id': 'OG001', 'title': 'XLK Poly', 'description': 'Cross-linked polyethylene'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '13.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Minimum 5 years, up to 7.6 years', 'description': 'WOMAC is a patient reported outcome (PRO) that evaluates the condition of subjects with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint. The total score ranged from 0 to 96. The subscales are combined (summed) to compute a total score, where a lower score indicates a better outcome.', 'unitOfMeasure': 'scores (points) on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Knees', 'denomUnitsSelected': 'Knees', 'populationDescription': 'The number of knees analyzed was the number available for analysis at this post-operative timepoint.'}, {'type': 'SECONDARY', 'title': 'Radiographic Outcomes - Percentage of Knees With Femoral Radiolucencies (>2mm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}, {'units': 'Knees', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GVF Poly', 'description': 'Gamma Vacuum Foil polyethylene'}, {'id': 'OG001', 'title': 'XLK Poly', 'description': 'Cross-linked polyethylene'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}, {'value': '7.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Minimum 5 years, up to 7.6 years', 'unitOfMeasure': 'percentage of knees', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Knees', 'denomUnitsSelected': 'Knees', 'populationDescription': 'The number of knees analyzed was the number available for analysis at this post-operative timepoint.'}, {'type': 'SECONDARY', 'title': 'Radiographic Outcomes - Percentage of Knees With Tibial Radiolucencies (>2mm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}, {'units': 'Knees', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GVF Poly', 'description': 'Gamma Vacuum Foil polyethylene'}, {'id': 'OG001', 'title': 'XLK Poly', 'description': 'Cross-linked polyethylene'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Minimum 5 years, up to 7.6 years', 'unitOfMeasure': 'percentage of knees', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Knees', 'denomUnitsSelected': 'Knees', 'populationDescription': 'The number of knees in which the radiographs were analyzed was the number available for analysis at this post-operative timepoint.'}, {'type': 'SECONDARY', 'title': 'Radiographic Outcomes - Percentage of Knees With Femoral Osteolysis (>2mm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}, {'units': 'Knees', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GVF Poly', 'description': 'Gamma Vacuum Foil polyethylene'}, {'id': 'OG001', 'title': 'XLK Poly', 'description': 'Cross-linked polyethylene'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Minimum 5 years, up to 7.6 years', 'unitOfMeasure': 'percentage of knees', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Knees', 'denomUnitsSelected': 'Knees', 'populationDescription': 'The number of knees in which radiographs were analyzed was the number available for analysis at this post-operative timepoint.'}, {'type': 'SECONDARY', 'title': 'Radiographic Outcomes - Percentage of Knees With Tibial Osteolysis (>2mm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}, {'units': 'Knees', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GVF Poly', 'description': 'Gamma Vacuum Foil polyethylene'}, {'id': 'OG001', 'title': 'XLK Poly', 'description': 'Cross-linked polyethylene'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Minimum 5 years, up to 7.6 years', 'unitOfMeasure': 'percentage of knees', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Knees', 'denomUnitsSelected': 'Knees', 'populationDescription': 'The number of knees in which radiographs were analyzed was the number available for analysis at this post-operative timepoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GVF Poly', 'description': 'Gamma Vacuum Foil polyethylene tibial component'}, {'id': 'FG001', 'title': 'XLK Poly', 'description': 'Cross-linked polyethylene tibial component'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '461'}, {'groupId': 'FG001', 'numSubjects': '477'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '189'}, {'groupId': 'FG001', 'numSubjects': '179'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '272'}, {'groupId': 'FG001', 'numSubjects': '298'}]}], 'dropWithdraws': [{'type': 'Non-study device implanted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up - Hurricane Katri', 'reasons': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'Revision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '115'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'BG000'}, {'value': '477', 'groupId': 'BG001'}, {'value': '926', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'GVF Poly', 'description': 'Gamma Vacuum Foil polyethylene tibial insert total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert'}, {'id': 'BG001', 'title': 'XLK Poly', 'description': 'Cross-linked polyethylene tibial insert total knee arthroplasty: cross-linked polyethylene tibial insert'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.3', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '66.4', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '66.3', 'spread': '8.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '290', 'groupId': 'BG000'}, {'value': '308', 'groupId': 'BG001'}, {'value': '598', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '328', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '449', 'groupId': 'BG000'}, {'value': '477', 'groupId': 'BG001'}, {'value': '926', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Enrolled Subjects'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 938}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2013-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-23', 'studyFirstSubmitDate': '2006-02-07', 'resultsFirstSubmitDate': '2014-05-30', 'studyFirstSubmitQcDate': '2006-02-07', 'lastUpdatePostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-05-31', 'studyFirstPostDateStruct': {'date': '2006-02-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survivorship (Revision of Any Component for Any Reason)', 'timeFrame': '5 years', 'description': 'Survival was estimated by Kaplan-Meier method. Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.'}], 'secondaryOutcomes': [{'measure': 'American Knee Society Evaluation - Total Score', 'timeFrame': '2 year', 'description': 'American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.'}, {'measure': 'American Knee Society Evaluation - Total Score', 'timeFrame': 'Minimum 5 years, up to 7.6 years', 'description': 'American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.'}, {'measure': 'Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score', 'timeFrame': '2 year', 'description': 'WOMAC is a patient reported outcome (PRO) that evaluates the condition of subjects with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint. The total score ranged from 0 to 96. The subscales are combined (summed) to compute a total score, where a lower score indicates a better outcome.'}, {'measure': 'Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score', 'timeFrame': 'Minimum 5 years, up to 7.6 years', 'description': 'WOMAC is a patient reported outcome (PRO) that evaluates the condition of subjects with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint. The total score ranged from 0 to 96. The subscales are combined (summed) to compute a total score, where a lower score indicates a better outcome.'}, {'measure': 'Radiographic Outcomes - Percentage of Knees With Femoral Radiolucencies (>2mm)', 'timeFrame': 'Minimum 5 years, up to 7.6 years'}, {'measure': 'Radiographic Outcomes - Percentage of Knees With Tibial Radiolucencies (>2mm)', 'timeFrame': 'Minimum 5 years, up to 7.6 years'}, {'measure': 'Radiographic Outcomes - Percentage of Knees With Femoral Osteolysis (>2mm)', 'timeFrame': 'Minimum 5 years, up to 7.6 years'}, {'measure': 'Radiographic Outcomes - Percentage of Knees With Tibial Osteolysis (>2mm)', 'timeFrame': 'Minimum 5 years, up to 7.6 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Arthroplasty, Replacement, Knee'], 'conditions': ['Osteoarthritis, Knee', 'Arthritis, Rheumatoid']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate long-term clinical and radiographic data between geometrically identical GVF and cross-linked polyethylene-bearing inserts in total knee arthroplasty.', 'detailedDescription': 'In 1996, Gamma Vacuum Foil (GVF) polyethylene was introduced as the first polyethylene to be gamma irradiated and packaged in an inert environment. This polyethylene, with its patented process and packaging, continues to be the only barrier-packaged process that is impermeable to both Hydrogen (H2) and Oxygen (O2), and allows the polyethylene to recombine and cross-link in the package. Though the new moderately cross-linked polyethylene being evaluated in this protocol is comparable to GVF geometrically and mechanically, the P.F.C.® Sigma™ cross-linked polyethylene also has the added benefit of being completely oxidatively stable both on the shelf and in-vivo.\n\nThe P.F.C. Sigma tibial tray component being assessed in this study is made of Cobalt Chrome (CoCr). The new CoCr tibial tray has the same design geometrically as the original titanium (Ti) tray, however, it features a highly polished top surface where it is joined to the polyethylene. This polished surface is designed to decrease the coefficient of friction between the polyethylene and the tray, thus minimizing backside wear. A comparative clinical study will be conducted to evaluate long-term clinical and radiographic data between geometrically identical cemented implants using GVF and crosslinked polyethylene tibial tray bearing inserts in Total Knee Arthroplasty (TKA) using the P.F.C. Sigma Total Knee System. Patients will be assigned to study treatment groups at random if they meet specific demographic and pathophysiologic criteria for cemented total knee arthroplasty. The anticipated duration of this investigation is a minimum six years, which includes a one-year enrollment phase.\n\nThe specific aims of this study are as follows:\n\n1. Examine whether crosslinked polyethylene performs as well, if not better, than GVF polyethylene through standard clinical evaluations.\n2. Evaluate long-term survivorship rates.\n3. Report complications/adverse events.\n4. Report radiographic findings of geometrically identical implants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Osteoarthritis of the affected joint appropriate for Total Knee Arthroplasty.\n2. Diagnosis of any of the following: rheumatoid or other inflammatory arthritis, post-traumatic arthritis, juvenile rheumatoid arthritis.\n3. Radiographic evidence of sufficient sound bone stock to seat and support the prosthesis.\n4. Subject requires a primary total knee replacement and is considered to be suitable for the specific knee prosthesis identified in protocol.\n5. Subject has given consent to the transfer of his/her information to sponsor.\n6. Subject will be compliant with requirements of protocol by returning for follow-up visits.\n\nExclusion Criteria:\n\n1. History of recent/active joint sepsis.\n2. Charcot neuropathy.\n3. Psycho-social disorders that would limit rehabilitation.\n4. Women who are pregnant or planning on being pregnant.\n5. Greater than 80 years of age at the time of surgery.\n6. Prior ipsilateral knee arthroplasty.\n7. Metabolic disorders of calcified tissues, such as Paget's disease.\n8. Severe diabetes mellitus that is not controlled by diet or oral agents.\n9. Require joint replacement due to immunodeficiency syndromes.\n10. Skeletal immaturity.\n11. Avascular necrosis of the affected knee.\n12. Chronic renal disease.\n13. Subjects involved in medical-legal or worker's compensation claims."}, 'identificationModule': {'nctId': 'NCT00289133', 'briefTitle': 'Gamma Vacuum Foil (GVF) Versus Cross-linked Polyethylene in Total Knee Arthroplasty Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'DePuy Orthopaedics'}, 'officialTitle': 'Prospective, Comparative, Randomized Study of GVF Versus Cross-linked Polyethylene in Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '03111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GVF', 'description': 'Gamma Vacuum Foil polyethylene tibial insert', 'interventionNames': ['Device: total knee arthroplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'P.F.C.', 'description': 'Cross-linked polyethylene tibial insert', 'interventionNames': ['Device: total knee arthroplasty']}], 'interventions': [{'name': 'total knee arthroplasty', 'type': 'DEVICE', 'description': 'Gamma Vacuum Foil polyethylene tibial insert', 'armGroupLabels': ['GVF']}, {'name': 'total knee arthroplasty', 'type': 'DEVICE', 'otherNames': ['P.F.C. Sigma cross-linked bearing'], 'description': 'cross-linked polyethylene tibial insert', 'armGroupLabels': ['P.F.C.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Orthopaedic Clinic', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '94705', 'city': 'Berkley', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Bone and Joint Clinic'}, {'zip': '80525', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Orthopedic Center of the Rockies', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Holy Cross Hospital', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32817', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Jewett Orthopaedic Clinic', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32792', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Jewett Orthopaedic Clinic', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '60153', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '61107', 'city': 'Rockford', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rockford Orthopedic Associates', 'geoPoint': {'lat': 42.27113, 'lon': -89.094}}, {'zip': '17402', 'city': 'York', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Orthopaedic & Spine Specialists', 'geoPoint': {'lat': 39.9626, 'lon': -76.72774}}], 'overallOfficials': [{'name': 'Gracia Etienne, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopaedic & Spine Specialists'}, {'name': 'Michael L. Granberry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alabama Orthopaedic Clinic'}, {'name': 'Richard M. Konsens, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jewett Orthopaedic Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DePuy Orthopaedics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}