Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT01063751
Status:
TERMINATED
Last Update Posted:
2025-04-16
First Post:
2010-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Tritanium® Primary Acetabular Shell Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D010020', 'term': 'Osteonecrosis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'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': 'filesha.haniff@stryker.com', 'phone': '1 470.528.9214', 'title': 'Filesha Haniff / Clinical Study Manager', 'organization': 'Stryker - Joint Replacement'}, 'certainAgreement': {'otherDetails': 'There is an agreement between Principal Investigators and the Sponsor (or its agents) that requires Investigators to allow Sponsor at least 30 days to review material intended for publications in order to redact any Confidential Information or Inventions therefrom.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Participants were assessed up to 10 years.', 'description': 'Censored cases were not included as at risk. Date of occurrence, date diagnosed, type of complication and treatment were collected. Industry standard adverse events (AE) and serious adverse events (SAE) terms were used in this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Operative Site Adverse Event(s)', 'description': 'Operative site adverse events are reported by study hip because in the case of bilateral participants (participants who have the study device implanted in both hips), an event can occur in one hip, both hips or the same hip, but at different times and are counted as separate events for this reason.', 'otherNumAtRisk': 241, 'deathsNumAtRisk': 241, 'otherNumAffected': 61, 'seriousNumAtRisk': 241, 'deathsNumAffected': 0, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Non-operative Site Adverse Event(s)', 'description': 'Non-operative site adverse events that were reported by participant.', 'otherNumAtRisk': 234, 'deathsNumAtRisk': 234, 'otherNumAffected': 0, 'seriousNumAtRisk': 234, 'deathsNumAffected': 13, 'seriousNumAffected': 56}], 'otherEvents': [{'term': 'Operative Site', 'notes': 'Tendonitis; Bursitis; Hip Pain; Soft Tissue Trauma; Groin Pain: Neuritis; Acetabular Component Loosening; Femoral Crack fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 90, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 234, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Operative Site', 'notes': 'Deep Joint Infection; Superficial Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Operative Site', 'notes': 'Wound Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Operative Site', 'notes': 'Acetabular Component Loosening; Femoral Component Loosening, Hip Pain, Femoral Crack Fracture, Trauma, Tibial Plateau Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-Operative', 'notes': 'Anemia; Hemolytic Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-Operative', 'notes': 'AV Block; A-FIB; NSTEMI; Abdominal Aortic Aneurysm; Angina / Acute Coronary Syndrome; Unstable Angina Pectoris; HTN; Exacerbation of CHF; CHF; Pacemaker Implant; HTN Crisis; Symptomatic Bradycardia with Hypotension; Vertigo; MI; Microcytic Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-Operative', 'notes': 'R-Eye Retinal Detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-operative', 'notes': 'Ischemic Colitis; Cholecystitis; Mild Postoperative Ileus; Partial SBO; Partial Bowel Obstruction; Small Bowel Obstruction; Acute Colitis and Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-Operative', 'notes': 'Death (cause unspecified); vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-Operative', 'notes': 'Acute Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-Operative', 'notes': 'Pneumonia; Infection; Urinary Tract Infection; Pneumonia, Acute Exacerbation of COPD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-Operative', 'notes': 'Herniated Disk; Tibial \\& Fibula Fractures, Sprained Muscle; Trauma; Lumbar Pain; Hip OA; Spinal Stenosis; Scoliosis; Herniated Nucleus Pulposus; Spondylosis; Knee OA; Lumbar/Lateral Recess Stenosis; MVC, Polytrauma; Rib Fractures; Subscap Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-Operative', 'notes': 'Breast; Colon; Osteosarcoma and Metastatic Osteosarcoma; Sarcoma; Leiomyosarcoma; Squamous Cell, Prostate; GI malignancy; Pituitary Adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-Operative', 'notes': 'Neuropathy; Lower Extremity Weakness; Altered Mental Status; Headaches; Aneurysm; Disorientation and Memory Loss; Idiopathic Tremor; Encephalopathy, Cognitive Decline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-operative', 'notes': 'Alcoholism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-Operative', 'notes': 'COPD; Exacerbation of COPD; Anaphylactic Shock (Insect Sting); Choked', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-Operative', 'notes': 'Evacuation of hematoma and removal of extruded herniated nucleus pulposus and endplate cartilage.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-Operative', 'notes': 'DVT; Pulmonary Embolism; Cerebrovascular Accident, Stroke, Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-Operative', 'notes': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Operative', 'notes': 'Femoral osteosarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absence of Acetabular Revision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '241', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanium® Primary Acetabular Shell', 'description': 'Tritanium® Primary Acetabular Shell\n\nTritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '5 years', 'description': 'To evaluate the success rate of cementless primary total hip replacement (THR) in hips implanted with the Tritanium® Acetabular Shell, as compared to the published results of similar acetabular components. Success will be defined as absence of acetabular shell revision for any reason at 5 years postoperative. It is expected that the survivorship of the Tritanium® Acetabular Shell group will be non-inferior to the survivorship reported in the literature for similar competitive devices.', 'unitOfMeasure': 'hips', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hips', 'denomUnitsSelected': 'hips'}, {'type': 'SECONDARY', 'title': 'Rates of Screw Fixation Usage in the Tritanium® Acetabular Shell', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '241', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanium® Primary Acetabular Shell', 'description': 'Tritanium® Primary Acetabular Shell\n\nTritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '178', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Intraoperative', 'description': 'Usage of bone screw fixation will be recorded and compared between the Tritanium® Acetabular Shell group and the Trident® Hemispherical Acetabular (HA) Shell group (Trident® X3® Polyethylene Insert Study).', 'unitOfMeasure': 'Hips', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Hips', 'denomUnitsSelected': 'Hips', 'populationDescription': 'Bone screws used.'}, {'type': 'SECONDARY', 'title': 'Harris Hip Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '241', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanium® Primary Acetabular Shell', 'description': 'Tritanium® Primary Acetabular Shell\n\nTritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement.'}], 'classes': [{'title': '1-Year Harris Hip Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '192', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.01', 'spread': '13.6', 'groupId': 'OG000'}]}]}, {'title': '3-Year Harris Hip Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.99', 'spread': '13.64', 'groupId': 'OG000'}]}]}, {'title': '5-Year Harris Hip Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.7', 'spread': '14.37', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1, 3, and 5 years', 'description': 'The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Hips', 'denomUnitsSelected': 'Hips', 'populationDescription': 'A calculable HHS score is a case where all data points are present to calculate the stated score.'}, {'type': 'SECONDARY', 'title': 'Short Form- 12 (SF-12) Heath Survey Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '241', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanium® Primary Acetabular Shell', 'description': 'Tritanium® Primary Acetabular Shell\n\nTritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement.'}], 'classes': [{'title': '1-Year Physical Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.77', 'spread': '10.45', 'groupId': 'OG000'}]}]}, {'title': '1-Year Mental Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.26', 'spread': '8.95', 'groupId': 'OG000'}]}]}, {'title': '3-Year Physical Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.62', 'spread': '10.48', 'groupId': 'OG000'}]}]}, {'title': '3-Year Mental Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.63', 'spread': '8.51', 'groupId': 'OG000'}]}]}, {'title': '5-Year Physical Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.68', 'spread': '10.38', 'groupId': 'OG000'}]}]}, {'title': '5-Year Mental Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.34', 'spread': '7.78', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1, 3, and 5 years', 'description': 'The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Hips', 'denomUnitsSelected': 'Hips', 'populationDescription': 'An evaluable case is one where all data points are present to calculate the stated score.'}, {'type': 'SECONDARY', 'title': 'Lower Extremity Activity Scale (LEAS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '241', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanium® Primary Acetabular Shell', 'description': 'Tritanium® Primary Acetabular Shell\n\nTritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement.'}], 'classes': [{'title': '1-Year LEAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.74', 'spread': '3.06', 'groupId': 'OG000'}]}]}, {'title': '3-Year LEAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.61', 'spread': '3.11', 'groupId': 'OG000'}]}]}, {'title': '5-Year LEAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.11', 'spread': '3.41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1, 3, and 5 years', 'description': 'The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Hips', 'denomUnitsSelected': 'Hips', 'populationDescription': 'An evaluable case is one where all data points are present to calculate the stated score.'}, {'type': 'SECONDARY', 'title': 'EuroQol Five-Dimensional (EQ-5D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '241', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanium® Primary Acetabular Shell', 'description': 'Tritanium® Primary Acetabular Shell\n\nTritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement.'}], 'classes': [{'title': '1-Year EQ5D Health State Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.87', 'spread': '17.32', 'groupId': 'OG000'}]}]}, {'title': '1-Year EQ5D TTO Valuation Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '.87', 'spread': '.16', 'groupId': 'OG000'}]}]}, {'title': '2-Year EQ5D Health State Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.87', 'spread': '17.01', 'groupId': 'OG000'}]}]}, {'title': '2-Year EQ5D TTO Valuation Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '.84', 'spread': '.18', 'groupId': 'OG000'}]}]}, {'title': '3-Year EQ5D Health State Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82.75', 'spread': '13.62', 'groupId': 'OG000'}]}]}, {'title': '3-Year EQ5D TTO Valuation Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '.88', 'spread': '.15', 'groupId': 'OG000'}]}]}, {'title': '4-Year EQ5D Health State Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '131', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.8', 'spread': '15.55', 'groupId': 'OG000'}]}]}, {'title': '4-Year EQ5D TTO Valuation Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '131', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '.86', 'spread': '.14', 'groupId': 'OG000'}]}]}, {'title': '5-Year EQ5D Health State Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.95', 'spread': '16.78', 'groupId': 'OG000'}]}]}, {'title': '5-Year EQ5D TTO Valuation Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '.86', 'spread': '.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1,2,3,4, and 5 years', 'description': 'The EuroQol five-dimensional (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas: the EQ visual analogue scale (EQ VAS) and EQ-5D descriptive system. The EQ VAS collects health state values using a 20 cm visual analogue scale with the endpoints labeled best imaginable health state at the top and worst imaginable health state at the bottom, having numeric values of 100 to 0 respectively. The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems, where an overall score of 1 represents full health.\n\nThe index values on a scale between -1 (low) and 1 (high) are showing the average health status. A low score shows worse health, and a high score shows better health.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Hips', 'denomUnitsSelected': 'Hips', 'populationDescription': 'A calculable case is one where all data points are present to calculate the stated score.'}, {'type': 'SECONDARY', 'title': 'Follow-Up Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '241', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanium® Primary Acetabular Shell', 'description': 'Tritanium® Primary Acetabular Shell\n\nTritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement.'}], 'classes': [{'title': '6-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - YES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': '6-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - NO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': '6-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - YES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}]}]}, {'title': '6-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - NO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': '6-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - YES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '6-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - NO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}, {'title': '7-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - YES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': '7-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - NO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': '7-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - YES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}, {'title': '7-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - NO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': '7-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - YES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '7-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - NO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}, {'title': '8-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - YES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': '8-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - NO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': '8-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - YES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}, {'title': '8-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - NO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': '8-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - YES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '8-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - NO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': '9-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - YES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': '9-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - NO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': '9-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - YES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': '9-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - NO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '9-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - YES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '9-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - NO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': '10-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - YES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': '10-Year_ Follow-up Questionnaire _Q1: Pain in Study Hip? - NO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': '10-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - YES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': '10-Year_Follow-up Questionnaire_Q2: Satisfied with Results of Hip Replacement? - NO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '10-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - YES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '10-Year_Follow-up Questionnaire_Q3: Surgery on Study Hip Since Last Study visit? - NO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '6, 7, 8, 9, and 10 years', 'description': 'The Follow-up Questionnaire is a short patient questionnaire intended to provide information on patient satisfaction, pain, and whether or not there have been any revisions or removals since the last follow-up visit. It consists of three questions:\n\n* Patient satisfaction with the hip replacement\n* Presence of any pain in the study hip\n* Any surgeries performed on the study hip', 'unitOfMeasure': 'Hips', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Hips', 'denomUnitsSelected': 'Hips', 'populationDescription': 'Not all participants completed the Follow-Up Questionnaire at the respective timepoints.'}, {'type': 'SECONDARY', 'title': 'Acetabular Shell Radiographic Stability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '241', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tritanium® Primary Acetabular Shell', 'description': 'Tritanium® Primary Acetabular Shell\n\nTritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement.'}], 'classes': [{'title': '6- Weeks Postoperative: Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '227', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '227', 'groupId': 'OG000'}]}]}, {'title': '6- Weeks Postoperative: Fibrous Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '227', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '6- Weeks Postoperative: Unstable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '227', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '1-Year Postoperative: Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '194', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '192', 'groupId': 'OG000'}]}]}, {'title': '1-Year Postoperative: Fibrous Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '194', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '1-Year Postoperative: Unstable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '194', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '3-Years Postoperative: Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}]}]}, {'title': '3-Years Postoperative: Fibrous Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': '3-Years Postoperative: Unstable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '5-Years Postoperative: Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}, {'title': '5-Years Postoperative: Fibrous Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': '5-Years Postoperative: Unstable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '6 weeks, 1, 3, 5 years', 'description': 'Numerous parameters will be reviewed by zone, including radiolucency and migration. All data will be evaluated in order to classify each case as stable or unstable.', 'unitOfMeasure': 'Hips', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Hips', 'denomUnitsSelected': 'Hips', 'populationDescription': 'Frequency of the acetabular shell stability.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tritanium® Primary Acetabular Shell', 'description': 'Tritanium® Primary Acetabular Shell\n\nTritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '275 subjects were enrolled making up 284 hip cases. There were 266 unilateral hip cases and 9 bilateral hips cases', 'groupId': 'FG000', 'numUnits': '284', 'numSubjects': '275'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '1 bilateral participant had 1 case/hip which completed the study and 1 case/hip which was censored from the study analyses. This participant is being included in the "Completed" category and will not be included in the "Censored from analyses" category.', 'groupId': 'FG000', 'numUnits': '43', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '241', 'numSubjects': '234'}]}], 'dropWithdraws': [{'type': 'Censored from analyses', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Sponsored Terminated Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'Cases terminated due to investigator leaving the site and site closure.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'Investigator site closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Revision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'typeUnitsAnalyzed': 'Hips', 'preAssignmentDetails': '275 participants/284 hip cases were enrolled. There were 266 unilateral hip cases and 9 bilateral hips cases.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'BG000'}]}, {'units': 'hips', 'counts': [{'value': '241', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tritanium® Primary Acetabular Shell', 'description': 'Tritanium® Primary Acetabular Shell\n\nTritanium® Primary Acetabular Shell: Tritanium® Primary Acetabular Shell in total hip replacement.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.60', 'groupId': 'BG000', 'lowerLimit': '31', 'upperLimit': '84'}]}]}], 'paramType': 'MEAN', 'description': 'For bilateral total knee replacement participants, the age at the time of initial knee replacement surgery is used.', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '100', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '134', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '207', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '241', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Cases', 'denomUnitsSelected': 'hips'}], 'typeUnitsAnalyzed': 'hips', 'populationDescription': '275 participants were enrolled making up 284 hip cases. Of the 284 hips, 43 cases were censored and not included in the data analyses. Therefore, 241 cases were included in the analyses.\n\nOf the 284 cases/234 participants, 42 cases completed the study per protocol. 40 participants made up these 42 cases.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-24', 'size': 6301756, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2023-06-08T16:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 275}}, 'statusModule': {'whyStopped': 'As longitudinal patient follow-up continues to lag, Stryker has determined that the study is no longer able to meet the regulatory requirements this study intends to support.\n\nTermination is not related to any safety concerns with the products.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'dispFirstSubmitDate': '2023-04-20', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-28', 'studyFirstSubmitDate': '2010-02-04', 'resultsFirstSubmitDate': '2023-06-16', 'studyFirstSubmitQcDate': '2010-02-04', 'dispFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-12', 'studyFirstPostDateStruct': {'date': '2010-02-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absence of Acetabular Revision', 'timeFrame': '5 years', 'description': 'To evaluate the success rate of cementless primary total hip replacement (THR) in hips implanted with the Tritanium® Acetabular Shell, as compared to the published results of similar acetabular components. Success will be defined as absence of acetabular shell revision for any reason at 5 years postoperative. It is expected that the survivorship of the Tritanium® Acetabular Shell group will be non-inferior to the survivorship reported in the literature for similar competitive devices.'}], 'secondaryOutcomes': [{'measure': 'Rates of Screw Fixation Usage in the Tritanium® Acetabular Shell', 'timeFrame': 'Intraoperative', 'description': 'Usage of bone screw fixation will be recorded and compared between the Tritanium® Acetabular Shell group and the Trident® Hemispherical Acetabular (HA) Shell group (Trident® X3® Polyethylene Insert Study).'}, {'measure': 'Harris Hip Score', 'timeFrame': '1, 3, and 5 years', 'description': 'The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor'}, {'measure': 'Short Form- 12 (SF-12) Heath Survey Scores', 'timeFrame': '1, 3, and 5 years', 'description': 'The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.'}, {'measure': 'Lower Extremity Activity Scale (LEAS) Score', 'timeFrame': '1, 3, and 5 years', 'description': 'The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.'}, {'measure': 'EuroQol Five-Dimensional (EQ-5D)', 'timeFrame': '1,2,3,4, and 5 years', 'description': 'The EuroQol five-dimensional (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas: the EQ visual analogue scale (EQ VAS) and EQ-5D descriptive system. The EQ VAS collects health state values using a 20 cm visual analogue scale with the endpoints labeled best imaginable health state at the top and worst imaginable health state at the bottom, having numeric values of 100 to 0 respectively. The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems, where an overall score of 1 represents full health.\n\nThe index values on a scale between -1 (low) and 1 (high) are showing the average health status. A low score shows worse health, and a high score shows better health.'}, {'measure': 'Follow-Up Questionnaire', 'timeFrame': '6, 7, 8, 9, and 10 years', 'description': 'The Follow-up Questionnaire is a short patient questionnaire intended to provide information on patient satisfaction, pain, and whether or not there have been any revisions or removals since the last follow-up visit. It consists of three questions:\n\n* Patient satisfaction with the hip replacement\n* Presence of any pain in the study hip\n* Any surgeries performed on the study hip'}, {'measure': 'Acetabular Shell Radiographic Stability', 'timeFrame': '6 weeks, 1, 3, 5 years', 'description': 'Numerous parameters will be reviewed by zone, including radiolucency and migration. All data will be evaluated in order to classify each case as stable or unstable.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'Traumatic arthritis', 'Avascular Necrosis'], 'conditions': ['Arthroplasty, Replacement, Hip']}, 'descriptionModule': {'briefSummary': 'This study will be a prospective, non-randomized evaluation of the Tritanium® Acetabular Shell for primary total hip replacement (THR) with a cementless application in a consecutive series of patients who meet the eligibility criteria. Half of the cases will use the Trident® X3® polyethylene insert alone as the bearing surface; the other half will use the modular dual mobility (MDM™) liner coupled with a compatible anatomic dual mobility (ADM™)/MDM™ X3® insert as the bearing surface.\n\nThe success rate, defined as freedom from acetabular revision for any reason, for hips implanted with the Tritanium® Acetabular Shell, is no worse than for hips implanted with similar technology as reported in the literature and Trident® X3® Study historical control at 5 years postoperative.', 'detailedDescription': "The Tritanium® Acetabular Shell, cleared for use under FDA 510(k) K081171, is a hemispherical acetabular shell with a 3D surface for biological fixation, fabricated from Commercially Pure Titanium (CPTi). The shell is built upon the design features and clinical history of the existing Trident® Tritanium®, Trident® AD, and Trident® hemispherical acetabular (HA) shells. The device is designed with a roughened surface and high coefficient of friction to resist micromotion and promote initial fixation. The Tritanium® Acetabular Shell, intended for use in a cementless application, is available in sizes from 44 millimeter (mm) through 66 mm and is compatible with Trident® polyethylene insert and acetabular screws. This advanced technology is designed to address the need for improved initial and biological fixation. Data in support of these marketing claims will be collected in the Tritanium® Primary Acetabular Shell Study.\n\nA prospective, post-market, multi-center design will be employed. Radiographs will be assessed by an independent reviewer.\n\nCases will be enrolled at 7 to 12 centers. The enrollment goal ranges from 20 to 34 cases implanted with the Tritanium® Acetabular Shell per center. The enrollment goal range is dependent upon the number of participating centers as well as the relative rates of enrollment of the two treatment groups. Although a range is presented, there is no maximum limit to the number of cases that a center may enroll. In the event that a center far exceeds the overall enrollment goal or enrollment into one of the treatment groups is completed, Stryker may ask the center to cease enrollment so as not to skew the data. All participating centers will comply with the federal regulations regarding patient informed consent and Institutional Review Board (IRB) approval. Non-compliance of a study center may result in termination of the center's participation in the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A. Patient has signed an IRB approved, study specific Informed Patient Consent Form.\n* B. Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.\n* C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).\n* D. Patient is a candidate for a primary cementless total hip replacement.\n* E. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.\n\nExclusion Criteria:\n\n* F. Patient has a Body Mass Index (BMI) ≥ 40.\n* G. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.\n* H. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.\n* I. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.\n* J. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \\> 30 days).\n* K. Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.\n* L. Patient has a known sensitivity to device materials.\n* M. Patient is a prisoner."}, 'identificationModule': {'nctId': 'NCT01063751', 'briefTitle': 'Tritanium® Primary Acetabular Shell Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stryker Orthopaedics'}, 'officialTitle': 'A Prospective, Post-market, Multi-center Study of the Tritanium® Acetabular Shell', 'orgStudyIdInfo': {'id': '69'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Tritanium® Primary Acetabular Shell', 'description': 'Tritanium® Primary Acetabular Shell', 'interventionNames': ['Device: Tritanium® Primary Acetabular Shell']}], 'interventions': [{'name': 'Tritanium® Primary Acetabular Shell', 'type': 'DEVICE', 'description': 'Tritanium® Primary Acetabular Shell in total hip replacement.', 'armGroupLabels': ['Tritanium® Primary Acetabular Shell']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94574', 'city': 'St. Helena', 'state': 'California', 'country': 'United States', 'facility': 'Adventist Health St. Helena', 'geoPoint': {'lat': 38.50519, 'lon': -122.47026}}, {'zip': '33542', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Medical Clinic', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky Research Foundation', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '70601', 'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Center for Orthopaedics and Spine, LLP', 'geoPoint': {'lat': 30.21309, 'lon': -93.2044}}, {'zip': '04401', 'city': 'Bangor', 'state': 'Maine', 'country': 'United States', 'facility': 'Northern Light Eastern Maine Medical Center', 'geoPoint': {'lat': 44.79884, 'lon': -68.77265}}, {'zip': '13214', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Syracuse Orthopedic Specialists, P.C.', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'Kevin Kopko, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Syracuse Orthopedic Specialists, P.C.'}, {'name': 'John Noble, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Orthopaedics and Spine, LLP'}, {'name': 'Carmen Crofoot, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northern Light Eastern Maine Medical Center'}, {'name': 'John Diana, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Adventist Health St. Helena'}, {'name': 'Stephen Duncan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky Research Foundation'}, {'name': 'Brock Lindsey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West Virginia University'}, {'name': 'Stephen Raterman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida Medical Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stryker Orthopaedics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}