Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-25 @ 2:10 PM
Study NCT ID:
NCT02851992
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-01
First Post:
2016-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lisette.smid@zimmerbiomet.com', 'phone': '+31 62 395 6378', 'title': 'Lisette Smid, Clinical Project Lead', 'organization': 'Zimmer Biomet'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'up to 2 years', 'description': 'Adverse Events are reported via a complication case report form completed by the Investigator', 'eventGroups': [{'id': 'EG000', 'title': 'GTS Cementless Stem', 'description': 'Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)\n\nGTS cementless stem: Total Hip Arthroplasty', 'otherNumAtRisk': 281, 'deathsNumAtRisk': 281, 'otherNumAffected': 32, 'seriousNumAtRisk': 281, 'deathsNumAffected': 0, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Withdrawn, Conflict with The Patient / Trial / Stop of Follow-Up', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LTF', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Withdrawn, not willing to return', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 7}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other hip related, bursitis trochanterica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': "Other hip related, the patient doesn't execute functional kine", 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture of femoral neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemorrhage', 'notes': 'linked to an overdose of anticoagulant, slower and long rehabilitation but no consequences', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other general complication, results and scores affected by knee pathology', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Femoral implant fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other general complication, total hip replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other general complication, total knee replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other general complication, Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Superficial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nerve injury, dropfoot left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other general complication, coxarthrosis contralateral hip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other general complication, coxarthrosis contralateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other general complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nerve injury, paralysis of the extra popliteal sciatic nerve', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Other hip related, Cupule conflict /psoas, cup too wide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall of patient resulting in revision', 'notes': 'Revision of the stem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislocation, 2/ DISLOCATION ON 06/26/15', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other hip related, psoas tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acetabular implant failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other hip related, left iliac fracture due to fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Femoral implant failure and fracture of femoral shaft', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other general complication and Thrombophlebitis of the calf', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other general complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Revision of cup & liner due to instability', 'notes': 'Revision of cup\\&liner', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Harris Hip Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GTS Cementless Stem', 'description': 'Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)\n\nGTS cementless stem: Total Hip Arthroplasty'}], 'classes': [{'title': 'pre-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.36', 'spread': '15.93', 'groupId': 'OG000'}]}]}, {'title': '2 year post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.75', 'spread': '6.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-operatively and 2 years post-operatively', 'description': 'Harris Hip Score (HHS) tests will be carried out pre-operatively and at each follow-up period.\n\nThe 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 minimum and maximum values of the scale are 0-100, with a higher score indicating a better outcome. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: \\< 70.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The HHS was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The score has a maximum of 100 points.'}, {'type': 'SECONDARY', 'title': 'Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GTS Cementless Stem', 'description': 'Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)\n\nGTS cementless stem: Total Hip Arthroplasty'}], 'classes': [{'title': 'Subsidence of the stem (1y)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'stem radiolucencies (1y)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Calcar resorption (1y)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Heterotopic ossification (1y)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year post-operatively', 'description': 'The presence or absence of the following femoral radiographic findings were reported: subsidence of the stem, stem radiolucencies, calcar resorption, heterotopic ossification.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'per-protocol population (all participants with 1 year radiographic evaluation available)'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GTS Cementless Stem', 'description': 'Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)\n\nGTS cementless stem: Total Hip Arthroplasty'}], 'classes': [{'title': 'pre-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.41', 'spread': '0.29', 'groupId': 'OG000'}]}]}, {'title': '2 years post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.96', 'spread': '0.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-operatively and 2 years post-operatively', 'description': 'EQ-5D quality of life score will be taken at every follow-up clinic and by postal questionnaire when patients are not attending a clinic.\n\nThe EQ-5D is a standardized instrument widely used to measure health status. The questionnaire includes 5 questions referring to mobility, self-care, daily activities, pain/discomfort and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. Scores will be within the range of 0-1 with 1 corresponding to perfect health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per-protocol population (number of subjects who completed the questionnaire were included in the analysis)'}, {'type': 'SECONDARY', 'title': 'Adverse Events/Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GTS Cementless Stem', 'description': 'Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)\n\nGTS cementless stem: Total Hip Arthroplasty'}], 'classes': [{'title': 'Revision', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'device-related SAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'until 2 years post-operatively', 'description': "The number of revisions/removals, device-related SAE's and deaths are listed.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Complications up to 2 years post-op'}, {'type': 'SECONDARY', 'title': 'Survivorship', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GTS Cementless Stem', 'description': 'Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)\n\nGTS cementless stem: Total Hip Arthroplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '278', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 2 years post-op', 'description': 'Survival of the implant based on the removal or intended removal of the device. The percentage of patients that still have the implant 2 years post-operative is presented here.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'per-protocol population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GTS Cementless Stem', 'description': 'Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)\n\nGTS cementless stem: Total Hip Arthroplasty'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '303'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '262'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'GTS Cementless Stem', 'description': 'Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)\n\nGTS cementless stem: Total Hip Arthroplasty'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '62.98', 'spread': '11.76', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '150', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '131', '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': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}]}]}, {'title': 'Netherlands', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosis', 'classes': [{'title': 'Primary Osteoarthritis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '225', 'groupId': 'BG000'}]}]}, {'title': 'Osteonecrosis of the femoral neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'congenital dysplasia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}, {'title': 'Inflammatory joint disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Post-traumatic arthritis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Femoral neck fracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '303 patients were enrolled in the study, 22 were excluded due to receiving a different device (20) or a screen failure (2), and therefore also not included in the baseline demographic analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-05-21', 'size': 123419, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-05T10:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 303}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-09', 'studyFirstSubmitDate': '2016-07-25', 'resultsFirstSubmitDate': '2023-07-07', 'studyFirstSubmitQcDate': '2016-08-01', 'lastUpdatePostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-09', 'studyFirstPostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Harris Hip Score', 'timeFrame': 'pre-operatively and 2 years post-operatively', 'description': 'Harris Hip Score (HHS) tests will be carried out pre-operatively and at each follow-up period.\n\nThe 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 minimum and maximum values of the scale are 0-100, with a higher score indicating a better outcome. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: \\< 70.'}], 'secondaryOutcomes': [{'measure': 'Stability, Incidence of Radiolucencies Around the Prosthesis and Bone Remodeling', 'timeFrame': '1 year post-operatively', 'description': 'The presence or absence of the following femoral radiographic findings were reported: subsidence of the stem, stem radiolucencies, calcar resorption, heterotopic ossification.'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'pre-operatively and 2 years post-operatively', 'description': 'EQ-5D quality of life score will be taken at every follow-up clinic and by postal questionnaire when patients are not attending a clinic.\n\nThe EQ-5D is a standardized instrument widely used to measure health status. The questionnaire includes 5 questions referring to mobility, self-care, daily activities, pain/discomfort and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. Scores will be within the range of 0-1 with 1 corresponding to perfect health.'}, {'measure': 'Adverse Events/Complications', 'timeFrame': 'until 2 years post-operatively', 'description': "The number of revisions/removals, device-related SAE's and deaths are listed."}, {'measure': 'Survivorship', 'timeFrame': 'at 2 years post-op', 'description': 'Survival of the implant based on the removal or intended removal of the device. The percentage of patients that still have the implant 2 years post-operative is presented here.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis, Hip']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, non-controlled, prospective study. 303 subjects (GTS standard and lateralized) have been recruited. Study will be conducted in centers across Europe.', 'detailedDescription': 'The objective of this prospective clinical study is to obtain multi-center, long-term (10-year) clinical data on the new GTS® femoral stem in its standard and lateralized versions as part of Post Market Surveillance requirements.\n\nThe initial study assessment period will be 12 years; 24 months recruitment and the follow-up clinical reviews for all patients will be at 3 months, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients inclusion criteria for this evaluation are be in accordance with the indications of the GTS® stem and specifically\n\n* Primary osteoarthritis or secondary coxarthritis\n* Inflammation of the hip: rheumatoid arthritis, etc.\n* Femoral neck fracture\n* Avascular necroses of the femoral head\n* Sequelae from previous operations on the hip, osteotomies, etc.\n* Congenital hip dysplasia\n\nAdditional inclusion criteria include:\n\n* 18 years of age or older\n* Subjects willing to return for follow-up evaluations\n* Subjects who read, understood study information and provided an informed written consent (specific local regulatory requirements)\n\nExclusion Criteria:\n\nExclusion criteria are in accordance with absolute and relative contraindications for use for GTS® stem\n\nAbsolute contraindications include:\n\n* Local or systemic infections.\n* Severe muscular, neurological or vascular deficiencies of the extremity involved\n* Bone destruction or poor bone quality that is likely to affect implant stability(Paget's disease, osteoporosis, etc.)\n* Concomitant disease likely to affect implant function\n* Allergy to any of the components of the implant\n* Patients weighing more than 110 kg\n\nAdditional exclusion criteria:\n\n* Subjects unable to co-operate with and complete the study\n* Dementia and/or inability to understand and follow instructions\n* Neurological conditions affecting movement\n* Patient over 18 under law supervision"}, 'identificationModule': {'nctId': 'NCT02851992', 'briefTitle': 'A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem', 'orgStudyIdInfo': {'id': 'ORTHO.CR.H36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'GTS cementless stem', 'description': 'Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene)', 'interventionNames': ['Device: GTS cementless stem']}], 'interventions': [{'name': 'GTS cementless stem', 'type': 'DEVICE', 'description': 'Total Hip Arthroplasty', 'armGroupLabels': ['GTS cementless stem']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}