Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT04079127
Status:
COMPLETED
Last Update Posted:
2021-05-14
First Post:
2019-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Avenir Müller Hip Stem Post Market Surveillance Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D006617', 'term': 'Hip Dislocation'}, {'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D004204', 'term': 'Joint Dislocations'}, {'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': 'Emilie.Rohmer@zimmerbiomet.com', 'phone': '+41 58 85 48210', 'title': 'Emilie Rohmer, Clinical Operations Manager', 'organization': 'Zimmer Biomet'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative).', 'description': 'All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Patients Suffering From Severe Hip Pain and Disability', 'description': 'Patients in need of a total hip arthroplasty.\n\nPatients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.: Consecutive cohort of patients enrolled at every site who received the Avenir Müller stem.', 'otherNumAtRisk': 141, 'deathsNumAtRisk': 141, 'otherNumAffected': 14, 'seriousNumAtRisk': 141, 'deathsNumAffected': 3, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Polymyalgia rheumatica', 'notes': 'Treated by medical corticosteroid.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney stone', 'notes': 'Treated by Lithotripsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaemia', 'notes': 'Treated by Medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'notes': 'Treated by Catheter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Arrhythmia', 'notes': 'Treated by Electrical Radioscopic Treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'notes': 'Treated by Antibiotics.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Infection', 'notes': 'Treated by Antibiotics', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'notes': 'Treated by operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislocation', 'notes': 'Treated by reduction with general anaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': "Hodgkin's disease", 'notes': 'Treated by hospitalizations and chemotherapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nephrectomy L and Partiel R', 'notes': 'Treated by surgery and hospitalization.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Instability', 'notes': 'Kept under surveillance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Subluxation', 'notes': 'Treated by hospitalisation traction Nonsteroidal anti-inflammatory drugs (NSAIDs)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankylosing Spondylartis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislocation', 'notes': 'Treated by reduction traction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Fracture of Femoral Shaft', 'notes': 'Treated by revision of the Avenir Muller Stem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bascule Implant cotyl', 'notes': 'Treated by revision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post traumatic Pain on acetabular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cup pain after Trauma', 'notes': 'Treated by revision of the Cup Head', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep Infection (>6 Weeks', 'notes': 'Treated by the revision of the whole prosthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Arrhythmia', 'notes': 'Treated by a pacemaker', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Retention', 'notes': 'Treated with a catheter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bascule Insert acetabular', 'notes': 'Treated by revision of the cup head', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myelofibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Reaction Due To Metal Bearing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metallosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Calcar crack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep Infection (>6 Weeks)', 'notes': 'Treated by rifadin and batrim', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Scar Inflammation', 'notes': 'Treated by Amoxiciline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'notes': 'Cause of Death unknown.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Evaluation of Pain and Functional Performance Determined by the Harris Hip Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Suffering From Severe Hip Pain and Disability', 'description': 'Patients in need of a total hip arthroplasty.\n\nPatients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.: Consecutive cohort of patients enrolled at every site who received the Avenir Müller stem.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.9', 'spread': '11.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 years', 'description': 'The Harris Hip Score is a questionnaire filled by the surgeon with the patient who received a hip implant. The domains covered are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication.\n\nThe function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction.\n\nThere are 10 items. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants', 'populationDescription': 'The HHS values are within the interval 0-100 points and the higher the score is, the better the outcome is for the individuals. The results are interpreted with the following ratings: \\<70 points = poor result; 70-79 points = fair, 80-89 points = good, and 90-100 points = excellent.\n\nNumber Of Unilateral Patients: 68; Number Of Bilateral Patients:7. Here, the data at 10 year post surgery of 75 patients (82 hips) were available for analysis.'}, {'type': 'SECONDARY', 'title': 'Confirmation of Safety Based on Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Suffering From Severe Hip Pain and Disability', 'description': 'Patients in need of a total hip arthroplasty.\n\nPatients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.: Consecutive cohort of patients enrolled at every site who received the Avenir Müller stem.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 10 years', 'description': 'Number of patients with adverse events related to the implant will be reported. Adverse events include: dislocations of the hip, revisions and removals of the implant components.\n\nHere, the entire cohort of patients (and hips) enrolled in the study were considered and are reported as the complications occured from the early stages of the study, and up to 10 year post surgery, and could occur to any patients.', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants', 'populationDescription': 'Revisions due to any component (Avenir Muller Hip Stem, Acetabular Insert , Acetabular Cup...) complication.'}, {'type': 'SECONDARY', 'title': 'Survivorship of the Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Suffering From Severe Hip Pain and Disability', 'description': 'Patients in need of a total hip arthroplasty.\n\nPatients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.: Consecutive cohort of patients enrolled at every site who received the Avenir Müller stem.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.54', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 years', 'description': 'Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method.\n\nHere, the entire cohort of patients (and hips) enrolled in the study were considered and are reported as the revisions could happen from the early stages of the study, and up to 10 year post surgery, and could occur to any patients. Even if a patient did not come back for a visit, the information if the implant was still in place was provided and taken into account for the survival analysis (gives higher numbers than for the clinical evaluation).', 'unitOfMeasure': 'percentage implant survival', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants', 'populationDescription': 'Kaplan-Meier survival rate at 10 years post-surgery,with Avenir Muller Hip Stem revision for any reason as endpoint.\n\nNumber of Unilateral Patients: 88; Number of Bilateral Patients: 4. Data of 88 patients,96 hips were received up to 10 years post surgery for the survival. Indeed, if a patient did not come back for a visit, the information if the implant was still in place was provided (gives higher numbers than for the clinical evaluation).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients Suffering From Severe Hip Pain and Disability', 'description': 'Patients in need of a total hip arthroplasty.\n\nPatients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.: Consecutive cohort of patients enrolled at every site who received the Avenir Müller stem.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'hips (in 141 patients)', 'groupId': 'FG000', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '89 hips have completed the study, and all 10 year data of 81 were available for analysis.', 'groupId': 'FG000', 'numSubjects': '89'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients Suffering From Severe Hip Pain and Disability', 'description': 'Patients in need of a total hip arthroplasty.\n\nConsecutive cohort of patients enrolled at every site who received the Avenir Müller stem and who met the study inclusion/exclusion criteria .'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '60.5', 'spread': '10.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '74', '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': 'Body Mass Index (BMI) kg/m2', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27.3', 'spread': '4.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height (cm)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '168.6', 'spread': '8.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight (kg)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '78.1', 'spread': '14.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2009-10-06', 'size': 99325, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-02T09:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-14', 'studyFirstSubmitDate': '2019-09-02', 'resultsFirstSubmitDate': '2020-04-15', 'studyFirstSubmitQcDate': '2019-09-04', 'lastUpdatePostDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-09', 'studyFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Pain and Functional Performance Determined by the Harris Hip Score', 'timeFrame': '10 years', 'description': 'The Harris Hip Score is a questionnaire filled by the surgeon with the patient who received a hip implant. The domains covered are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication.\n\nThe function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction.\n\nThere are 10 items. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).'}], 'secondaryOutcomes': [{'measure': 'Confirmation of Safety Based on Complications', 'timeFrame': 'up to 10 years', 'description': 'Number of patients with adverse events related to the implant will be reported. Adverse events include: dislocations of the hip, revisions and removals of the implant components.\n\nHere, the entire cohort of patients (and hips) enrolled in the study were considered and are reported as the complications occured from the early stages of the study, and up to 10 year post surgery, and could occur to any patients.'}, {'measure': 'Survivorship of the Implant', 'timeFrame': '10 years', 'description': 'Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method.\n\nHere, the entire cohort of patients (and hips) enrolled in the study were considered and are reported as the revisions could happen from the early stages of the study, and up to 10 year post surgery, and could occur to any patients. Even if a patient did not come back for a visit, the information if the implant was still in place was provided and taken into account for the survival analysis (gives higher numbers than for the clinical evaluation).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False}, 'conditionsModule': {'conditions': ['Osteoarthritis, Hip', 'Rheumatoid Arthritis', 'Fracture of Hip', 'Dislocated Hip', 'Osteonecrosis', 'Post-traumatic; Arthrosis', 'Subluxation Hip']}, 'referencesModule': {'references': [{'pmid': '30415580', 'type': 'RESULT', 'citation': 'Erivan R, Villatte G, Brientini JM, Kreider D, Descamps S, Boisgard S. 7-year results of primary total hip arthroplasty with the uncemented Avenir stem. Hip Int. 2019 Jul;29(4):418-423. doi: 10.1177/1120700018810211. Epub 2018 Nov 11.'}]}, 'descriptionModule': {'briefSummary': 'This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2. The data collected from this study will serve the purpose of confirming safety and performance of the Avenir Müller Hip Stem.', 'detailedDescription': 'The objective of this post market surveillance study is to obtain outcome data on the Avenir Müller Hip Stem by analysis of standard scoring systems, radiographs and adverse event records, and thus to assess the long-term performance and safety of this implant.\n\nThis is a multi-centre, retrospective post-market surveillance study involving orthopaedic surgeons skilled in hip surgery. Each case enrolled has received the Avenir Müller Hip Stem for a primary hip arthroplasty. The Avenir Müller Hip Stem is CE marked (European Conformity) and commercially available.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from severe hip pain and disability requiring a total hip arthroplasty.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients able to participate in a follow-up program based upon physical examination and medical history.\n* Patients or patient's legal representatives who have given written consent to take part in the study by signing the 'Patient Consent Form'.\n* 18 years minimum.\n* Male and female.\n* Baseline data exist (pre-, peri- and immediate postoperative)\n\nExclusion Criteria:\n\n* Patients who are unwilling or unable to comply with the follow-up program.\n* Known pregnancy.\n* Patients who are skeletally immature."}, 'identificationModule': {'nctId': 'NCT04079127', 'briefTitle': 'Avenir Müller Hip Stem Post Market Surveillance Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'A Multi-centre, Non-comparative, Retrospective Post-market Surveillance Study to Obtain Clinical Outcomes Data on the Zimmer Avenir Müller Hip Stem', 'orgStudyIdInfo': {'id': '09H08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients suffering from severe hip pain and disability', 'description': 'Patients in need of a total hip arthroplasty.', 'interventionNames': ['Device: Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.']}], 'interventions': [{'name': 'Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.', 'type': 'DEVICE', 'description': 'Consecutive cohort of patients enrolled at every site who received the Avenir Müller stem.', 'armGroupLabels': ['Patients suffering from severe hip pain and disability']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Paola Vivoda', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zimmer Biomet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}