Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2026-02-26 @ 4:31 PM
Study NCT ID:
NCT02062450
Status:
COMPLETED
Last Update Posted:
2017-05-04
First Post:
2014-02-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Observational Study Evaluating Outcomes of Hip Arthroplasty Using Tornier Dual Mobility Acetabular Cup
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005271', 'term': 'Femur Head Necrosis'}, {'id': 'D005265', 'term': 'Femoral Neck Fractures'}], 'ancestors': [{'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006620', 'term': 'Hip Fractures'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012086', 'term': 'Reoperation'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nathalie.tretout@tornier.com', 'phone': '+33 4 76 71 35 00', 'title': 'Nathalie TRETOUT', 'organization': 'TORNIER SAS'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '2 years postoperative', 'eventGroups': [{'id': 'EG000', 'title': 'Total Safety Population', 'description': 'All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.', 'otherNumAtRisk': 379, 'otherNumAffected': 11, 'seriousNumAtRisk': 379, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Primary Surgery Sub-group', 'description': 'Patients who underwent a Primary Hip Replacement surgery', 'otherNumAtRisk': 191, 'otherNumAffected': 4, 'seriousNumAtRisk': 191, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Revision Surgery Sub-group', 'description': 'Patients who underwent a Revision Hip Replacement surgery', 'otherNumAtRisk': 64, 'otherNumAffected': 2, 'seriousNumAtRisk': 64, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Infection without revision surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Recurrent Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound affection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Asymptomatic implant mobilisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Dual Mobility Cup dislocation', 'notes': 'Orthopedic reduction only - No Revision surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Revision surgery for Implant Mobilisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Revision surgery for Implant Loosening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Revision surgery for Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Revision surgery for Implant Malposition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Revision surgery for Instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Transfemoral Amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteosynthesis surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteolysis surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With an Implant Dislocation After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Safety Population', 'description': 'All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-year postoperative', 'description': 'The primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '2 implants dislocations were reported in the 379 patients making up the Total Safety Population, of which 1 concerned a Primary surgery and the other concerned a Revision surgery. In both cases, orthopaedic reduction was performed without changing the implant.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With an Implant Dislocation After Surgery (= Dislocation Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Safety Population', 'description': 'All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.53', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-year postoperative', 'description': 'The primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Performance - PMA Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Surgery Sub-group', 'description': 'Patients who undergone a primary hip replacement surgery'}, {'id': 'OG001', 'title': 'Revision Sub-group', 'description': 'patients who undergone a revision hip replacement surgery'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.8', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '3.3', 'groupId': 'OG001'}]}]}, {'title': '2-y FU visit', 'categories': [{'measurements': [{'value': '16.4', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '15.2', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Improvement at 2-y FU vs Baseline', 'categories': [{'measurements': [{'value': '6.1', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '3.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years postoperative', 'description': "Postel-Merle-d'Aubigné (PMA) score is known since 1954 and is a very widespread mean of evaluating the clinical function of the hip by the physician.\n\nIt contains three items: pain, function and hip mobility, each noted on 6 points (0 is the worst possible score and 18 is the best possible score) :\n\n* a score between 15 and 18 points is defined as good,\n* a score between 12 and 14 points is defined as average,\n* a score inferior to 12 is defined as bad", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Performance - HOOS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Surgery Sub-group', 'description': 'Patients who undergone a primary hip replacement surgery'}, {'id': 'OG001', 'title': 'Revision Sub-group', 'description': 'patients who undergone a revision hip replacement surgery'}], 'classes': [{'title': 'Pain', 'categories': [{'measurements': [{'value': '91.8', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '86.4', 'spread': '15.1', 'groupId': 'OG001'}]}]}, {'title': 'Symptoms', 'categories': [{'measurements': [{'value': '87.5', 'spread': '15.1', 'groupId': 'OG000'}, {'value': '84.5', 'spread': '13.4', 'groupId': 'OG001'}]}]}, {'title': 'Daily living', 'categories': [{'measurements': [{'value': '84.2', 'spread': '22.0', 'groupId': 'OG000'}, {'value': '76.6', 'spread': '18.2', 'groupId': 'OG001'}]}]}, {'title': 'Sports and recreational activities)', 'categories': [{'measurements': [{'value': '63.8', 'spread': '33.2', 'groupId': 'OG000'}, {'value': '43.2', 'spread': '27.6', 'groupId': 'OG001'}]}]}, {'title': 'Quality of Life', 'categories': [{'measurements': [{'value': '85.2', 'spread': '20.5', 'groupId': 'OG000'}, {'value': '67.0', 'spread': '26.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years postoperative', 'description': "The HOOS (Hip disability and Osteoarthritis Outcome Score) is a patient questionnaire evaluating patients' feelings about their operated hip. It consists of 40 questions divided into 5 subgroups: pain, symptoms, daily living, quality of life, sports and recreational activities. Each category is scored on 100 points, 0 being the worse outcome and 100 the best outcome.", 'unitOfMeasure': 'units on a scale of 100', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Performance - HARRIS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Surgery Sub-group', 'description': 'Patients who undergone a primary hip replacement surgery'}, {'id': 'OG001', 'title': 'Revision Sub-group', 'description': 'patients who undergone a revision hip replacement surgery'}], 'classes': [{'title': 'Excellent', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Mediocre', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-year postoperative', 'description': 'The HARRIS score is a physician questionnaire assessing hip pain, function and mobility on a total of 100 points, 100 being the maximum score. A result between 90 and 100 points is considered "excellent", between 80 and 90 "good", between 70 and 80 "mediocre" and less than 70 "poor".', 'unitOfMeasure': 'percentage of partipants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Implant Survivorship', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Safety Population', 'description': 'All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-year postoperative', 'description': 'Implant survivorship criteria was assessed by investigators during patients visits : is the implanted device still in place 2 years after surgery ? Negative answers were quantified.', 'unitOfMeasure': 'percentage of implants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hip Acetabular Replacement, Using a Dual Mobility Cup.', 'description': 'Studied cohort includes 2 subgroups :\n\n* Patients with primary hip replacement.\n* Patients with revision surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '379 patients were successfully reached by phone and convoked for the 2-year follow-up visit.', 'groupId': 'FG000', 'numSubjects': '379'}]}, {'type': 'Per Protocol Cohort', 'achievements': [{'comment': '255 patients attended their 2-year follow-up visit.', 'groupId': 'FG000', 'numSubjects': '255'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '255'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}]}], 'dropWithdraws': [{'type': 'No follow-up visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '124'}]}]}], 'recruitmentDetails': '472 patients who underwent hip arthroplasty with a Dual Mobility Cup between September 2010 and December 2011, in the 5 participating centers, have been identified.\n\n379 out of them have been successfully reached by phone to be convoked for their 2-year postoperative follow-up visit. The other 93 patients were considered "lost to follow-up".', 'preAssignmentDetails': 'Of the 379 contacted patients, 255 came to visit their surgeons for the 2-year follow-up. The other 124 who declined to visit were evaluated by phone for safety criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '255', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Primary Surgery', 'description': 'Patients who underwent a primary hip replacement surgery with Dual Mobility Cup'}, {'id': 'BG001', 'title': 'Revision Surgery', 'description': 'Patients who underwent a revision hip replacement surgery with Dual Mobility Cup'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.7', 'spread': '9.4', 'groupId': 'BG000'}, {'value': '71.3', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '72.2', 'spread': '10.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '191', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '255', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'A total of 255 patients were included in the Global Study Cohort of which 191 had a Primary Hip surgery and 64 had a Revision Hip surgery.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 379}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-02', 'studyFirstSubmitDate': '2014-02-11', 'resultsFirstSubmitDate': '2015-12-09', 'studyFirstSubmitQcDate': '2014-02-12', 'lastUpdatePostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-04-11', 'studyFirstPostDateStruct': {'date': '2014-02-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With an Implant Dislocation After Surgery', 'timeFrame': '2-year postoperative', 'description': 'The primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.'}, {'measure': 'Percentage of Participants With an Implant Dislocation After Surgery (= Dislocation Rate)', 'timeFrame': '2-year postoperative', 'description': 'The primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.'}, {'measure': 'Implant Survivorship', 'timeFrame': '2-year postoperative', 'description': 'Implant survivorship criteria was assessed by investigators during patients visits : is the implanted device still in place 2 years after surgery ? Negative answers were quantified.'}], 'secondaryOutcomes': [{'measure': 'Clinical Performance - PMA Score', 'timeFrame': '2 years postoperative', 'description': "Postel-Merle-d'Aubigné (PMA) score is known since 1954 and is a very widespread mean of evaluating the clinical function of the hip by the physician.\n\nIt contains three items: pain, function and hip mobility, each noted on 6 points (0 is the worst possible score and 18 is the best possible score) :\n\n* a score between 15 and 18 points is defined as good,\n* a score between 12 and 14 points is defined as average,\n* a score inferior to 12 is defined as bad"}, {'measure': 'Clinical Performance - HOOS Score', 'timeFrame': '2 years postoperative', 'description': "The HOOS (Hip disability and Osteoarthritis Outcome Score) is a patient questionnaire evaluating patients' feelings about their operated hip. It consists of 40 questions divided into 5 subgroups: pain, symptoms, daily living, quality of life, sports and recreational activities. Each category is scored on 100 points, 0 being the worse outcome and 100 the best outcome."}, {'measure': 'Clinical Performance - HARRIS Score', 'timeFrame': '2-year postoperative', 'description': 'The HARRIS score is a physician questionnaire assessing hip pain, function and mobility on a total of 100 points, 100 being the maximum score. A result between 90 and 100 points is considered "excellent", between 80 and 90 "good", between 70 and 80 "mediocre" and less than 70 "poor".'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Arthroplasty', 'Hip Replacement', 'Acetabular cup', 'Dual mobility', 'Hip revision surgery'], 'conditions': ['Primary Osteoarthritis', 'Post-traumatic Osteoarthritis of Hip Nos', 'Femur Head Necrosis', 'Femur Neck Fracture', 'Congenital Dislocations']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the performance and reliability of Tornier "Dual Mobility Cup" used during primary total hip replacement or hip replacement revision surgery at least 24 months post-insertion.', 'detailedDescription': 'The PURPOSE of this study is to demonstrate the performance and reliability of the Tornier "Dual Mobility Cup" used during primary total hip replacement or hip replacement revision surgery at a minimum of 24 months post-implantation. The primary endpoint is to determine the dislocation rate observed during post-surgical follow-up. The secondary endpoints are to assess, in the short-term, the following: clinical performance on the basis of clinical scores and hip mobility; radiological performance, particularly in terms of positioning and fixation of the implant; as well as the reliability of the implantation of this acetabular cup on the basis of any complications observed'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The global cohort: All the patients who received a Tornier Dual Mobility acetabular cup between October 2010 and October 2011 and who we were able to be contacted by phone.\n\n"Primary replacement" group: All the patients who received a Tornier Dual Mobility acetabular cup between October 2010 and October 2011 for primary hip replacement and who were seen for their follow-up visit at 2 years post-procedure.\n\n"Revision" group: All patients who received a Tornier Dual Mobility acetabular cup between October 2010 and October 2011 for revision surgery and who were seen for their follow-up visit at 2 years post-procedure.\n\nAll the performance criteria were analysed for the patients in the "Primary replacement" and "Revision" groups', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men and women aged over 18, undergoing total hip replacement with insertion of a Dual Mobility acetabular cup between October 2010 and October 2011,\n* capable of attending the 2-year follow-up visit;\n* capable of understanding the information about the study and agreeing to take part in it.\n\nExclusion Criteria:\n\n* patients with tumoral pathology.'}, 'identificationModule': {'nctId': 'NCT02062450', 'briefTitle': 'Observational Study Evaluating Outcomes of Hip Arthroplasty Using Tornier Dual Mobility Acetabular Cup', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stryker Trauma and Extremities'}, 'officialTitle': 'Multicentre, Observational Study Evaluating the Clinical and Radiological Outcomes of Hip Arthroplasty Using the Dual Mobility Cup', 'orgStudyIdInfo': {'id': '1204-T-DOUBLEMOB-RM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary surgery with Dual Mobility Cup', 'description': 'Patients having a Primary Hip acetabular replacement, using a Dual Mobility Cup.', 'interventionNames': ['Device: Primary surgery with Dual Mobility Cup']}, {'label': 'Revision surgery with Dual Mobility Cup', 'description': 'Patients having a Revision Hip acetabular replacement, using a Dual Mobility Cup.', 'interventionNames': ['Device: Revision surgery with Dual Mobility Cup']}], 'interventions': [{'name': 'Primary surgery with Dual Mobility Cup', 'type': 'DEVICE', 'description': 'Hip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component.', 'armGroupLabels': ['Primary surgery with Dual Mobility Cup']}, {'name': 'Revision surgery with Dual Mobility Cup', 'type': 'DEVICE', 'description': 'Hip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component.', 'armGroupLabels': ['Revision surgery with Dual Mobility Cup']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Christophe Hulet, MD, PR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Caen University Hospital, FR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stryker Trauma and Extremities', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}