Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-24 @ 3:44 PM
Study NCT ID:
NCT01883492
Status:
TERMINATED
Last Update Posted:
2020-02-17
First Post:
2013-01-31
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Prospective Multi-center Study on Total Hip Arthroplasty With E1
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': 'takahito.nakai@zimmerbiomet.com', 'phone': '+81-3-6402-6610', 'title': 'Senior Manager of Clinical Affairs', 'organization': 'Zimmer Biomet G.K.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 year after surgery', 'eventGroups': [{'id': 'EG000', 'title': 'BIOLOX Delta Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nBiolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 2, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'CoCr Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nCoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 1, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Intraoperative Trochanteric Fracture', 'notes': 'Surgical Procedure related intraoperative fracture of Trochanter of Femur.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Femoral Nerve Palsy', 'notes': 'Surgical Procedure related femoral nerve palsy. Symptom was disappeared although no specific treatment was conducted.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappropriate femoral stem position', 'notes': 'Intraoperative stem insertion to prepared femoral canal was not optimal, so it was revised two weeks after primary surgery.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Polyethylene Wear Between Immediate Postoperative and 2 Year Postoperative Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIOLOX Delta Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nBiolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}, {'id': 'OG001', 'title': 'CoCr Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nCoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}], 'classes': [{'categories': [{'measurements': [{'value': '0.42', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediate postoperative and 2 year postoperatively', 'description': 'Vector wear, which is defined as movement (difference of femoral prosthetic head positions) between immediate postoperative and 2 years postoperative periods. There is no lower and upper limit, actual measured results. The outcome can be negative value.', 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants, whose x-ray taken at 2 year follow-up visit being available.'}, {'type': 'SECONDARY', 'title': 'Harris Hip Score at 6 Month Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIOLOX Delta Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nBiolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}, {'id': 'OG001', 'title': 'CoCr Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nCoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}], 'classes': [{'categories': [{'measurements': [{'value': '92.67', 'spread': '8.05', 'groupId': 'OG000'}, {'value': '92.61', 'spread': '7.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 month postoperative', 'description': 'Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion".\n\nMinimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 patient in BIOLOX delta head group and 13 patients in CoCr head group missed collecting Harris Hip Score at 6 month visit.'}, {'type': 'SECONDARY', 'title': 'Harris Hip Score at 1 Year Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIOLOX Delta Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nBiolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}, {'id': 'OG001', 'title': 'CoCr Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nCoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}], 'classes': [{'categories': [{'measurements': [{'value': '95.23', 'spread': '6.10', 'groupId': 'OG000'}, {'value': '94.52', 'spread': '6.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year postoperative', 'description': 'Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion".\n\nMinimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 patient in BIOLOX delta head group and 6 patients in CoCr head group missed collecting Harris Hip Score at 1 year visit.'}, {'type': 'SECONDARY', 'title': 'Harris Hip Score at 2 Year Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIOLOX Delta Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nBiolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}, {'id': 'OG001', 'title': 'CoCr Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nCoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}], 'classes': [{'categories': [{'measurements': [{'value': '96.15', 'spread': '5.44', 'groupId': 'OG000'}, {'value': '96.28', 'spread': '5.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 year postoperative', 'description': 'Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion".\n\nMinimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 patients in BIOLOX delta head group and 9 patients in CoCr head group missed collecting Harris Hip Score at 2 year visit.'}, {'type': 'SECONDARY', 'title': 'Harris Hip Score at 3 Year Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIOLOX Delta Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nBiolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}, {'id': 'OG001', 'title': 'CoCr Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nCoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}], 'classes': [{'categories': [{'measurements': [{'value': '96.30', 'spread': '4.56', 'groupId': 'OG000'}, {'value': '96.82', 'spread': '6.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 year postoperative', 'description': 'Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion".\n\nMinimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '12 patients in BIOLOX delta head group and 12 patients in CoCr head group missed collecting Harris Hip Score at 3 year visit.'}, {'type': 'SECONDARY', 'title': 'WOMAC Osteoarthritis Index at 6 Month Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIOLOX Delta Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nBiolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}, {'id': 'OG001', 'title': 'CoCr Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nCoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}], 'classes': [{'categories': [{'measurements': [{'value': '9.27', 'spread': '9.75', 'groupId': 'OG000'}, {'value': '10.43', 'spread': '9.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 month postoperative', 'description': 'The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.\n\nThe scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.\n\nHigher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.\n\nHigher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '6 patients in BIOLOX delta head group and 11 patients in CoCr head group missed colleting WOMAC questionnaire at 6 month visit.'}, {'type': 'SECONDARY', 'title': 'WOMAC Osteoarthritis Index at 1 Year Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIOLOX Delta Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nBiolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}, {'id': 'OG001', 'title': 'CoCr Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nCoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}], 'classes': [{'categories': [{'measurements': [{'value': '9.86', 'spread': '13.52', 'groupId': 'OG000'}, {'value': '9.57', 'spread': '9.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year postoperative', 'description': 'The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.\n\nThe scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.\n\nHigher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '6 patients in BIOLOX delta head group and 13 patients in CoCr head group missed colleting WOMAC questionnaire at 1 year visit.'}, {'type': 'SECONDARY', 'title': 'WOMAC Osteoarthritis Index at 2 Year Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIOLOX Delta Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nBiolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}, {'id': 'OG001', 'title': 'CoCr Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nCoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}], 'classes': [{'categories': [{'measurements': [{'value': '7.85', 'spread': '8.88', 'groupId': 'OG000'}, {'value': '7.80', 'spread': '10.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 year postoperative', 'description': 'The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.\n\nThe scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.\n\nHigher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '9 patients in BIOLOX delta head group and 16 patients in CoCr head group missed colleting WOMAC questionnaire at 2 year visit.'}, {'type': 'SECONDARY', 'title': 'WOMAC Osteoarthritis Index at 3 Year Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIOLOX Delta Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nBiolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}, {'id': 'OG001', 'title': 'CoCr Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nCoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}], 'classes': [{'categories': [{'measurements': [{'value': '8.29', 'spread': '9.31', 'groupId': 'OG000'}, {'value': '6.84', 'spread': '8.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 year postoperative', 'description': 'The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.\n\nThe scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.\n\nHigher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '14 patients in BIOLOX delta head group and 17 patients in CoCr head group missed colleting WOMAC questionnaire at 3 year visit.'}, {'type': 'SECONDARY', 'title': 'UCLA Activity Score at 6 Month Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIOLOX Delta Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nBiolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}, {'id': 'OG001', 'title': 'CoCr Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nCoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}], 'classes': [{'categories': [{'measurements': [{'value': '5.19', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '4.75', 'spread': '1.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 month postoperative', 'description': "University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.\n\nThe score ranges from 1 to 10 (1 point increment), higher score means higher activity level.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '4 patients in BIOLOX delta head group and 12 patients in CoCr head group missed colleting UCLA Activity score at 6 month visit.'}, {'type': 'SECONDARY', 'title': 'UCLA Activity Score at 1 Year Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIOLOX Delta Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nBiolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}, {'id': 'OG001', 'title': 'CoCr Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nCoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}], 'classes': [{'categories': [{'measurements': [{'value': '5.45', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '5.03', 'spread': '1.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year postoperative', 'description': "University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.\n\nThe score ranges from 1 to 10 (1 point increment), higher score means higher activity level.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients in BIOLOX delta head group and 8 patients in CoCr head group missed colleting UCLA Activity score at 1 year visit.'}, {'type': 'SECONDARY', 'title': 'UCLA Activity Score at 2 Year Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIOLOX Delta Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nBiolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}, {'id': 'OG001', 'title': 'CoCr Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nCoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}], 'classes': [{'categories': [{'measurements': [{'value': '5.53', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '5.31', 'spread': '1.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 year postoperative', 'description': "University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.\n\nThe score ranges from 1 to 10 (1 point increment), higher score means higher activity level.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 patients in BIOLOX delta head group and 9 patients in CoCr head group missed colleting UCLA Activity score at 2 year visit.'}, {'type': 'SECONDARY', 'title': 'UCLA Activity Score at 3 Year Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIOLOX Delta Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nBiolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}, {'id': 'OG001', 'title': 'CoCr Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nCoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}], 'classes': [{'categories': [{'measurements': [{'value': '5.42', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '5.43', 'spread': '1.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 year postoperative', 'description': "University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.\n\nThe score ranges from 1 to 10 (1 point increment), higher score means higher activity level.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '12 patients in BIOLOX delta head group and 11 patients in CoCr head group missed colleting UCLA Activity score at 3 year visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BIOLOX Delta Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nBiolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}, {'id': 'FG001', 'title': 'CoCr Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nCoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Surgery on contra-lateral hip', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Poor X-ray quality', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'inappropriate implant used', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'bone anatomy did not meet study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BIOLOX Delta Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nBiolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}, {'id': 'BG001', 'title': 'CoCr Head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nCoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.\n\nFemoral Stem: JMDN classification/Class III device\n\nAcetabular Cup: JMDN classification: Class III device\n\nAcetabular Liner: JMDN classification: Class III device'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.90', 'spread': '7.16', 'groupId': 'BG000'}, {'value': '61.94', 'spread': '7.26', 'groupId': 'BG001'}, {'value': '61.92', 'spread': '7.18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Harris Hip Score', 'classes': [{'categories': [{'measurements': [{'value': '55.11', 'spread': '11.65', 'groupId': 'BG000'}, {'value': '52.63', 'spread': '11.67', 'groupId': 'BG001'}, {'value': '53.83', 'spread': '11.68', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion".\n\nMinimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'WOMAC osteoarthritis index', 'classes': [{'categories': [{'measurements': [{'value': '40.75', 'spread': '17.09', 'groupId': 'BG000'}, {'value': '41.24', 'spread': '15.29', 'groupId': 'BG001'}, {'value': '41.00', 'spread': '16.13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.\n\nThe scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.\n\nHigher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'UCLA Activity Score', 'classes': [{'categories': [{'measurements': [{'value': '2.95', 'spread': '0.95', 'groupId': 'BG000'}, {'value': '3.28', 'spread': '1.10', 'groupId': 'BG001'}, {'value': '3.12', 'spread': '1.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.\n\nThe score ranges from 1 to 10 (1 point increment), higher score means higher activity level.", 'unitOfMeasure': 'score on scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-02-29', 'size': 2428945, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-06T23:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'whyStopped': 'Enrollment of the subject could not reach statistically required number.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-03', 'studyFirstSubmitDate': '2013-01-31', 'resultsFirstSubmitDate': '2020-01-20', 'studyFirstSubmitQcDate': '2013-06-19', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-03', 'studyFirstPostDateStruct': {'date': '2013-06-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Polyethylene Wear Between Immediate Postoperative and 2 Year Postoperative Period', 'timeFrame': 'Immediate postoperative and 2 year postoperatively', 'description': 'Vector wear, which is defined as movement (difference of femoral prosthetic head positions) between immediate postoperative and 2 years postoperative periods. There is no lower and upper limit, actual measured results. The outcome can be negative value.'}], 'secondaryOutcomes': [{'measure': 'Harris Hip Score at 6 Month Follow-up Visit', 'timeFrame': '6 month postoperative', 'description': 'Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion".\n\nMinimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.'}, {'measure': 'Harris Hip Score at 1 Year Follow-up Visit', 'timeFrame': '1 year postoperative', 'description': 'Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion".\n\nMinimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.'}, {'measure': 'Harris Hip Score at 2 Year Follow-up Visit', 'timeFrame': '2 year postoperative', 'description': 'Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion".\n\nMinimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.'}, {'measure': 'Harris Hip Score at 3 Year Follow-up Visit', 'timeFrame': '3 year postoperative', 'description': 'Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion".\n\nMinimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.'}, {'measure': 'WOMAC Osteoarthritis Index at 6 Month Follow-up Visit', 'timeFrame': '6 month postoperative', 'description': 'The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.\n\nThe scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.\n\nHigher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.\n\nHigher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.'}, {'measure': 'WOMAC Osteoarthritis Index at 1 Year Follow-up Visit', 'timeFrame': '1 year postoperative', 'description': 'The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.\n\nThe scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.\n\nHigher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.'}, {'measure': 'WOMAC Osteoarthritis Index at 2 Year Follow-up Visit', 'timeFrame': '2 year postoperative', 'description': 'The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.\n\nThe scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.\n\nHigher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.'}, {'measure': 'WOMAC Osteoarthritis Index at 3 Year Follow-up Visit', 'timeFrame': '3 year postoperative', 'description': 'The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.\n\nThe scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.\n\nHigher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.'}, {'measure': 'UCLA Activity Score at 6 Month Follow-up Visit', 'timeFrame': '6 month postoperative', 'description': "University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.\n\nThe score ranges from 1 to 10 (1 point increment), higher score means higher activity level."}, {'measure': 'UCLA Activity Score at 1 Year Follow-up Visit', 'timeFrame': '1 year postoperative', 'description': "University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.\n\nThe score ranges from 1 to 10 (1 point increment), higher score means higher activity level."}, {'measure': 'UCLA Activity Score at 2 Year Follow-up Visit', 'timeFrame': '2 year postoperative', 'description': "University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.\n\nThe score ranges from 1 to 10 (1 point increment), higher score means higher activity level."}, {'measure': 'UCLA Activity Score at 3 Year Follow-up Visit', 'timeFrame': '3 year postoperative', 'description': "University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.\n\nThe score ranges from 1 to 10 (1 point increment), higher score means higher activity level."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Only Female', 'Age between 20 - 75 at the time of operation'], 'conditions': ['Hip Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The primary objectives of this clinical study include:\n\n* Evaluate E1 Wear including early bedding-in process, clinical outcomes on patients who received Total Hip Arthroplasty with E1\n* Compare E1 wear used with CoCr and Biolox Delta heads', 'detailedDescription': 'This study is designed as PROSPECTIVE, RANDOMIZED, MULTI-CENTER Study to compare two different materials (CoCr and Delta ceramic) articulating against E1 Highly Crosslinked polyethylene in Hip Replacement.\n\nPatient population is 160 (80 each). Follow-up period is 10 year postoperatively. E1 liners with thickness of 4.8mm at 45 degrees position (load bearing direction) will be used in all cases.\n\nRandomization will occur via random number generator by 4 blocks randomization.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Osteoarthritis\n* Age between 20 - 75 at the time of operation\n* Patients with limited co-morbidity -ASA I-III\n* Patients must be able to understand instructions and be willing to return for follow up\n\nExclusion Criteria:\n\n* In accordance with approved Absolute and Relative Contraindications for use in participating countries for E1 liner and Delta Ceramic and CoCr femoral head hip system System.\n\nAbsolute contraindications include: infection, sepsis, and osteomyelitis.\n\nRelative contraindications include:\n\n1. uncooperative patient or patient with neurologic disorders who are incapable of following directions,\n2. osteoporosis,\n3. metabolic disorders which may impair bone formation,\n4. osteomalacia,\n5. distant foci of infections which may spread to the implant site,\n6. rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and\n7. vascular insufficiency, muscular atrophy, or neuromuscular disease.\n8. pregnancy'}, 'identificationModule': {'nctId': 'NCT01883492', 'briefTitle': 'A Prospective Multi-center Study on Total Hip Arthroplasty With E1', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'A Prospective Multi-center Randomized Study on Total Hip Replacement With E1', 'orgStudyIdInfo': {'id': 'INT.CR.GH2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIOLOX delta head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nBiolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.', 'interventionNames': ['Device: Femoral Stem', 'Device: Acetabular Cup', 'Device: Acetabular Liner']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CoCr head', 'description': 'Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).\n\nAcetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.\n\nCoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.', 'interventionNames': ['Device: Femoral Stem', 'Device: Acetabular Cup', 'Device: Acetabular Liner']}], 'interventions': [{'name': 'Femoral Stem', 'type': 'DEVICE', 'otherNames': ['Taperloc Complete', 'Taperloc Microplasty Complete', 'Taperloc Complete XR123', 'Taperloc Microplasty Complete XR123'], 'description': 'JMDN classification/Class III device', 'armGroupLabels': ['BIOLOX delta head', 'CoCr head']}, {'name': 'Acetabular Cup', 'type': 'DEVICE', 'otherNames': ['Ringloc Acetabular Cup', 'Regenerex Ringloc+ Acetabular Cup'], 'description': 'JMDN classification: Class III device', 'armGroupLabels': ['BIOLOX delta head', 'CoCr head']}, {'name': 'Acetabular Liner', 'type': 'DEVICE', 'otherNames': ['E1 Ringloc Liner'], 'description': 'JMDN classification: Class III device', 'armGroupLabels': ['BIOLOX delta head', 'CoCr head']}]}, 'contactsLocationsModule': {'locations': [{'zip': '814-0180', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Fukuoka University School of Medicine', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '252-0374', 'city': 'Sagamihara', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Kitasato University School of Medicine', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'zip': '530-0012', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Saiseikai Nakatsu Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '108-8642', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Kitasato University Kitasato Institute Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '160-8582', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Keio University School of Medicine', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Hirotsugu Ohashi, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saiseikai Nakatsu Hospital'}, {'name': 'Arihiko Kanaji, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Keio University'}, {'name': 'Katsufumi Uchiyama, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kitasato University School of Medicine'}, {'name': 'Hironori Kaneko, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kitasato University Kitasato Institute Hospital'}, {'name': 'Koichi Kinoshita, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fukuoka University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}