Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2026-01-04 @ 8:39 AM
Study NCT ID:
NCT03672916
Status:
COMPLETED
Last Update Posted:
2025-02-12
First Post:
2018-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'martina.hersberger@zimmerbiomet.com', 'phone': '+41 79 535 90 29', 'title': 'Martina Hersberger, Clinical Project Lead', 'organization': 'Zimmer Biomet'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From surgery until the last study visit at 10 years post-op.', 'description': 'ISO definitions are applicable', 'eventGroups': [{'id': 'EG000', 'title': 'Patients Who Received the Allofit IT With BIOLOX Delta', 'description': 'Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners', 'otherNumAtRisk': 185, 'deathsNumAtRisk': 185, 'otherNumAffected': 52, 'seriousNumAtRisk': 185, 'deathsNumAffected': 6, 'seriousNumAffected': 45}], 'otherEvents': [{'term': 'Study-hip affected adverse events', 'notes': 'Squeaking hip (N=4), pain due to a fall (N=1), periprosthetic femur fracture (N=1)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal (non-study hip)', 'notes': 'Includes osteoarthritis other joints, fractures, pain, etc', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 36, 'numAffected': 28}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oncological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endocrine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Others', 'notes': 'Psychiatric disorder (N=2), Respiratory (N=1), Gastrointestinal (N=1), Dermatological (N=1),', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Study-hip affected: Revisions of implant system', 'notes': 'One or more components revised. Reasons for revision: dislocation (N=4), femur fracture (N=1), deep infection (N=1)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Study-hip affected: Luxation/Dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Study-hip affected: Periprosthetic femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal (non-study hip)', 'notes': 'Includes contralateral THA, TKAs, etc', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 26, 'numAffected': 22}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oncological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection (non-study hip)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary/Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Reported deaths with unknown causes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Survivorship', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Who Received the Allofit IT With BIOLOX Delta', 'description': 'Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners'}], 'classes': [{'categories': [{'measurements': [{'value': '179', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 years post-surgery', 'description': 'The objective of this study is implant survival at 10 years which is assessed by revision of the the study device calculated using the Kaplan-Meier Survival Estimation. The survivorship with Kaplan-Meier (K-M) was calculated at 10 year for endpoint revision of any component.', 'unitOfMeasure': 'Implants', 'reportingStatus': 'POSTED', 'populationDescription': 'All study patients'}, {'type': 'PRIMARY', 'title': 'Safety of the Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Who Received the Allofit IT With BIOLOX Delta', 'description': 'Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners'}], 'classes': [{'title': 'Hip Related complications (AE and SAE)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Revisions', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': "SAE's not related to study hip", 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 10 years postoperative', 'description': 'Will be evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) b) Efficacy:', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The count of all participants with adverse events is summarized. Details are available in the Adverse Event overview of the results section'}, {'type': 'SECONDARY', 'title': 'Harris Hip Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Who Received the Allofit IT With BIOLOX Delta', 'description': 'Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners'}], 'classes': [{'title': 'Pre-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.8', 'spread': '11.5', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.2', 'spread': '11.3', 'groupId': 'OG000'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.1', 'spread': '7.9', 'groupId': 'OG000'}]}]}, {'title': '2 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.9', 'spread': '6.9', 'groupId': 'OG000'}]}]}, {'title': '3 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.1', 'spread': '9', 'groupId': 'OG000'}]}]}, {'title': '5 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.2', 'spread': '9.5', 'groupId': 'OG000'}]}]}, {'title': '7 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.0', 'spread': '8.3', 'groupId': 'OG000'}]}]}, {'title': '10 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.9', 'spread': '11.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year', 'description': 'The Harris Hip Score (HHS) is an outcome measure that includes a series of questions answered by the patient and physical examinations recorded by a qualified health care professional. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). To obtain a final score, the points are summed. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: \\< 70', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All study patients'}, {'type': 'SECONDARY', 'title': 'EQ-5D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Who Received the Allofit IT With BIOLOX Delta', 'description': 'Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners'}], 'classes': [{'title': 'pre-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.3', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.2', 'groupId': 'OG000'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.2', 'groupId': 'OG000'}]}]}, {'title': '2 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.2', 'groupId': 'OG000'}]}]}, {'title': '3 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.2', 'groupId': 'OG000'}]}]}, {'title': '5 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.2', 'groupId': 'OG000'}]}]}, {'title': '7 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.2', 'groupId': 'OG000'}]}]}, {'title': '10 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year', 'description': "The EQ-5D-3L is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life. The questionnaire includes five dimensions referring to mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each question can be answered in three ways/levels indicating no problems, some problems, and extreme problems. In the derived EQ-5D-3L score, the highest score is 1 and the lowest score is -0.594; negative numbers correspond to a self-assessed health state worse than being dead.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants decreased over time, reasons are: questionnaire not completed in full (score calculation not possible), missed visits, lost to follow-up or withdrawn from the study.'}, {'type': 'SECONDARY', 'title': 'SF-12 Physical and Mental Functional Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Who Received the Allofit IT With BIOLOX Delta', 'description': 'Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners'}], 'classes': [{'title': 'Pre-op, SF12 Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.8', 'spread': '7.1', 'groupId': 'OG000'}]}]}, {'title': '6 months, SF12 Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.5', 'spread': '9.9', 'groupId': 'OG000'}]}]}, {'title': '1 Year, SF12 Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.5', 'spread': '8.9', 'groupId': 'OG000'}]}]}, {'title': '2 Year, SF12 Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49.5', 'spread': '9.3', 'groupId': 'OG000'}]}]}, {'title': '3 Year, SF12 Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47.0', 'spread': '10.6', 'groupId': 'OG000'}]}]}, {'title': '5 Year, SF12 Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.9', 'spread': '9.8', 'groupId': 'OG000'}]}]}, {'title': '7 Year, SF12 Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47.2', 'spread': '10.8', 'groupId': 'OG000'}]}]}, {'title': '10 Year, SF12 Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47.3', 'spread': '9.9', 'groupId': 'OG000'}]}]}, {'title': 'Pre-op, SF12 Mental', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.9', 'spread': '11.8', 'groupId': 'OG000'}]}]}, {'title': '6 months, SF12 Mental', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.7', 'spread': '7.9', 'groupId': 'OG000'}]}]}, {'title': '1 Year, SF12 Mental', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.0', 'spread': '7.8', 'groupId': 'OG000'}]}]}, {'title': '2 Year, SF12 Mental', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.6', 'spread': '7.2', 'groupId': 'OG000'}]}]}, {'title': '3 Year, SF12 Mental', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.6', 'spread': '8.4', 'groupId': 'OG000'}]}]}, {'title': '5 Year, SF12 Mental', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.1', 'spread': '9.1', 'groupId': 'OG000'}]}]}, {'title': '7 Year, SF12 Mental', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.5', 'spread': '10.4', 'groupId': 'OG000'}]}]}, {'title': '10 Year, SF12 Mental', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.2', 'spread': '8.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year', 'description': 'The SF-12 is a multipurpose short-form (SF) generic measure of health status. It consists of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). Scores ranges from 0 to 100, with higher scores indicating better physical and mental health functioning and lower scores indicating worse physical and mental health functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All study patients'}, {'type': 'SECONDARY', 'title': 'UCLA Activity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Who Received the Allofit IT With BIOLOX Delta', 'description': 'Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners'}], 'classes': [{'title': 'Pre-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.1', 'spread': '1.7', 'groupId': 'OG000'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.4', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': '2 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.6', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': '3 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.2', 'spread': '1.7', 'groupId': 'OG000'}]}]}, {'title': '5 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.4', 'spread': '1.7', 'groupId': 'OG000'}]}]}, {'title': '7 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '1.9', 'groupId': 'OG000'}]}]}, {'title': '10 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.4', 'spread': '1.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year', 'description': "The case administered University of California at Los Angeles (UCLA) score allows assessment of the case's activity level at each time point with scores from 1 (Wholly inactive: dependent on others; cannot leave residence) to 10 (Regularly participates in impact sports)", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants decreased over time, reasons are: questionnaire not completed, missed visits, lost to follow-up or withdrawn from the study.'}, {'type': 'SECONDARY', 'title': 'Radiographic Evaluations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Who Received the Allofit IT With BIOLOX Delta', 'description': 'Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners'}], 'classes': [{'title': 'Stem Subsidence (0.2mm - 6mm)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Radiolucency (>2mm)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Cup Migration (0.3mm - 0.9mm)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Osteolysis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Heterotopic Ossification (Class III and class IV)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Calcar Resorption (0.3mm - 5mm)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 Years post-surgery', 'description': 'Radiographic evaluation was done to assess (radiolucency, osteolysis, subsidence, cup migration, change in cup angle and change in femoral shaft angle) of study subjects who received the Allofit IT Acetabular System', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All study patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients Who Received the Allofit IT With BIOLOX Delta', 'description': 'Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '185'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients Who Received the Allofit IT With BIOLOX Delta', 'description': 'Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '56.4', 'spread': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Age (years) at date of surgery', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '66', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '118', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-15', 'size': 295030, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-22T08:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-22', 'studyFirstSubmitDate': '2018-09-13', 'resultsFirstSubmitDate': '2024-04-18', 'studyFirstSubmitQcDate': '2018-09-13', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-22', 'studyFirstPostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survivorship', 'timeFrame': '10 years post-surgery', 'description': 'The objective of this study is implant survival at 10 years which is assessed by revision of the the study device calculated using the Kaplan-Meier Survival Estimation. The survivorship with Kaplan-Meier (K-M) was calculated at 10 year for endpoint revision of any component.'}, {'measure': 'Safety of the Implant', 'timeFrame': 'Up to 10 years postoperative', 'description': 'Will be evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) b) Efficacy:'}], 'secondaryOutcomes': [{'measure': 'Harris Hip Score', 'timeFrame': 'pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year', 'description': 'The Harris Hip Score (HHS) is an outcome measure that includes a series of questions answered by the patient and physical examinations recorded by a qualified health care professional. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). To obtain a final score, the points are summed. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: \\< 70'}, {'measure': 'EQ-5D', 'timeFrame': 'pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year', 'description': "The EQ-5D-3L is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life. The questionnaire includes five dimensions referring to mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each question can be answered in three ways/levels indicating no problems, some problems, and extreme problems. In the derived EQ-5D-3L score, the highest score is 1 and the lowest score is -0.594; negative numbers correspond to a self-assessed health state worse than being dead."}, {'measure': 'SF-12 Physical and Mental Functional Scores', 'timeFrame': 'pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year', 'description': 'The SF-12 is a multipurpose short-form (SF) generic measure of health status. It consists of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). Scores ranges from 0 to 100, with higher scores indicating better physical and mental health functioning and lower scores indicating worse physical and mental health functioning.'}, {'measure': 'UCLA Activity Score', 'timeFrame': 'pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year', 'description': "The case administered University of California at Los Angeles (UCLA) score allows assessment of the case's activity level at each time point with scores from 1 (Wholly inactive: dependent on others; cannot leave residence) to 10 (Regularly participates in impact sports)"}, {'measure': 'Radiographic Evaluations', 'timeFrame': '10 Years post-surgery', 'description': 'Radiographic evaluation was done to assess (radiolucency, osteolysis, subsidence, cup migration, change in cup angle and change in femoral shaft angle) of study subjects who received the Allofit IT Acetabular System'}]}, 'oversightModule': {'isFdaRegulatedDrug': False}, 'conditionsModule': {'keywords': ['Total hip arthroplasty', 'Medical Device', 'Safety', 'Hip prosthesis'], 'conditions': ['Avascular Necrosis of Hip', 'Osteoarthritis, Hip', 'Inflammatory Arthritis', 'Post-Traumatic Osteoarthritis of Hip']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, prospective, non-controlled post market surveillance study. The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty.', 'detailedDescription': 'The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty.\n\nThis will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility and survivorship, and to confirm the safety and performance of the Allofit IT Ceramic Bearing System.\n\nA total of 200 patients are planned to be enrolled in this study which will last 12 years (2 year enrollment plus 10 years follow-up) with the follow-up visits at 6 months, 1, 2, 3, 5, 7, and 10 years post-operatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be comprised of a maximum of 200 males and females who require primary total hip arthroplasty. Subjects will be enrolled at 4 investigative centers. Subjects must be geographically accessible throughout the study and be willing and able to attend required follow-up appointments. Candidates who express interest in study participation will be offered informed consent, and eligibility will be determined based upon the inclusion/exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is 18 to 75 years of age, inclusive.\n* Patient is skeletally mature.\n* Patient qualifies for primary unilateral or bilateral total hip arthroplasty (THA) based on physical exam and medical history including the following:\n\n * Avascular necrosis (AVN)\n * Osteoarthritis (OA)\n * Inflammatory arthritis (i.e. Rheumatoid arthritis)\n * Post-traumatic arthritis\n* Patient has no history of previous prosthetic replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) of the affected hip joint(s).\n* Patient has a Harris Hip Score \\<70 in the affected hip\n* Patient is willing and able to provide written informed consent.\n* Patient is willing and able to cooperate in the required post-operative therapy.\n* Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.\n* Patient has participated in the Informed Consent process and has signed the Ethics Committee approved informed consent.\n\nExclusion Criteria:\n\n* The patient is:\n\n * A prisoner\n * Mentally incompetent or unable to understand what participation in the study entails\n * A known alcohol or drug abuser\n * Anticipated to be non-compliant.\n* The patient has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care.\n* The patient has a vascular (large and small vessel disease) insufficiency.\n* The patient has a neurologic condition in the ipsalateral or contralateral limb which affects lower limb function.\n* The patient has a diagnosed systemic disease that could affect his/her safety or the study outcome.\n* The patient is known to be pregnant.\n* The patient is unwilling or unable to give informed consent, or to comply with the follow-up program.\n* The patient has received an investigational drug or device within the previous 6 months.\n* The patient has an active or latent infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously.\n* The patient has insufficient bone stock to fix the component. Insufficient bone stock exists in the presence of metabolic bone disease (i.e. osteoporosis), cancer, and radiation. Note: Dual Energy X-ray Absorptiometry (DEXA) may be used to assess the presence of adequate bone stock.\n* The patient has osteoradionecrosis in the operative hip joint\n* The patient has a known sensitivity or allergic reaction to one or more of the implanted materials.\n* The patient has known local bone tumors in the operative hip.\n* The patient is Grade III obese with a Body Mass Index (BMI) \\> 40.'}, 'identificationModule': {'nctId': 'NCT03672916', 'briefTitle': 'Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty: A Multi-center, Prospective, Non-controlled Post Market Surveillance Study', 'orgStudyIdInfo': {'id': 'CME2010-24H'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients who received the Allofit IT with BIOLOX delta', 'description': 'Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners'}]}, 'contactsLocationsModule': {'locations': [{'zip': '16766', 'city': 'Kremmen', 'country': 'Germany', 'facility': 'Sana Kliniken Sommerfeld', 'geoPoint': {'lat': 52.76216, 'lon': 13.02515}}, {'zip': '39120', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Magdeburg A.ö.R.', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '41749', 'city': 'Viersen', 'country': 'Germany', 'facility': 'LVR-Klinik für Orthopädie', 'geoPoint': {'lat': 51.25435, 'lon': 6.39441}}, {'zip': '221 85', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Skåne University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Hassan Achakri', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zimmer Biomet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}