Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-28 @ 4:05 AM
Study NCT ID:
NCT00957658
Status:
COMPLETED
Last Update Posted:
2017-08-14
First Post:
2009-08-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Accolade® TMZF® Hip Stem Outcomes Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Ellen.Axelson@stryker.com', 'phone': '201-831-5401', 'title': 'Director of Clinical Research', 'organization': 'Stryker Orthopaedics'}, 'certainAgreement': {'otherDetails': "Each investigator shall have privileges for their own center's results at the completion of the study. These manuscripts and abstracts will be delayed until after the multi-center publication is submitted.All publications shall be submitted to the sponsor for review at least 60 days prior to submission for publication.The sponsor shall not edit or otherwise influence the publications other than to ensure that confidential information is not disclosed and that the data is accurately represented.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'This study requires that all operative site and serious systemic adverse events be reported from enrollment to 5 years postoperative. Censored protocol violations were not included as at risk participants.', 'description': 'Elective procedures not included.e.g.non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular \\& bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,\\& mid/flat-foot surgery. Industry standard AE terms not used; specific AE terms not used for all AEs', 'eventGroups': [{'id': 'EG000', 'title': 'Accolade TMZF Hip Stem', 'description': 'Participants who received the Accolade TMZF Hip Stem', 'otherNumAtRisk': 234, 'otherNumAffected': 54, 'seriousNumAtRisk': 234, 'seriousNumAffected': 65}], 'otherEvents': [{'term': 'Operative site Musculoskeletal and Connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 63, 'numAffected': 54}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-operative site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Accolade® TMZF® Hip Stem', 'description': 'Accolade® TMZF® Hip Stem Study Device'}], 'classes': [{'categories': [{'measurements': [{'value': '98.85', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000'], 'groupDescription': 'Literature control = 96% with no aseptic loosening, intraop femoral fracture or thigh pain at 2 years', 'statisticalMethod': 'Asymptotic WALD test', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority margin = 6%'}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'unitOfMeasure': 'percentage of hips', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hips', 'denomUnitsSelected': 'hips'}, {'type': 'SECONDARY', 'title': 'Percentage (%) of Hip Stems With Aseptic Loosening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Accolade® TMZF® Hip Stem', 'description': 'Subjects who received the Accolade® TMZF® Hip Stem'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Aseptic loosening is defined as a continuous radiolucency that surrounds the entire femoral stem porous coating-bone interface and that measures greater than 2 mm in thickness, and 5 mm or more of stem subsidence. Continuous radiolucency must be present in Zones 1, 2, 6 and 7 of the AP radiographic view and/or present in Zones 8, 9, 13 and 14 of the M/L radiographic view.', 'unitOfMeasure': 'percentage of hips', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hips', 'denomUnitsSelected': 'hips', 'populationDescription': 'Participants with available data: 111 hips in 106 participants had a radiographic evaluation at 5 years.'}, {'type': 'SECONDARY', 'title': 'Revision/Removal Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}, {'units': 'hip', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Accolade® TMZF® Hip Stem', 'description': 'Subjects who received the Accolade® TMZF® Hip Stem'}], 'classes': [{'title': 'Revision/removal rate % at 2 years', 'categories': [{'measurements': [{'value': '1.65', 'groupId': 'OG000'}]}]}, {'title': 'Revision/removal rate % at 5 years', 'categories': [{'measurements': [{'value': '2.84', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 and 5 years', 'description': 'The percentage (%) of hips with revision or removal of any total hip replacement component (acetabular cup, femoral stem or femoral head) is reported at the 2 and 5 year postoperative intervals.', 'unitOfMeasure': 'percentage of hips/any component revised', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hip', 'denomUnitsSelected': 'hip', 'populationDescription': 'Participants with available data: The revision/removal rate of any total hip replacement component at 2 years is reported for 182 hips/176 participants. The revision/removal rate of any component at 5 years is reported for 141 hips/136 participants.'}, {'type': 'SECONDARY', 'title': 'Change in Harris Hip Score (HHS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '195', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Accolade® TMZF® Hip Stem', 'description': 'Subjects who received the Accolade® TMZF® Hip Stem'}], 'classes': [{'title': 'Mean HHS score Preoperative (n=195)', 'categories': [{'measurements': [{'value': '50.1', 'spread': '11.99', 'groupId': 'OG000'}]}]}, {'title': 'Mean HHS score 2 years (n=174)', 'categories': [{'measurements': [{'value': '89.4', 'spread': '12.67', 'groupId': 'OG000'}]}]}, {'title': 'Mean HHS score 5 years (N=117)', 'categories': [{'measurements': [{'value': '92.2', 'spread': '12.61', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000'], 'groupDescription': 'Improvement from preop to 2 year and preop to 5 year', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Preoperative, 2 and 5 years', 'description': 'The change in HHS is reported by comparing the mean preoperative, 2 and 5 year postoperative scores. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent, 80-89 = good, 70-79 = fair, 0-69 = poor.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hips', 'denomUnitsSelected': 'hips', 'populationDescription': 'Participants with available data: A total of 195 hips had a preoperative score, 174 had a 2 year score, and 117 had a 5 year score.'}, {'type': 'SECONDARY', 'title': 'Change in SF-12 Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '217', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Accolade® TMZF® Hip Stem', 'description': 'Accolade® TMZF® Hip Stem.'}], 'classes': [{'title': 'Mean SF12 Physical Preoperative (N=217)', 'categories': [{'measurements': [{'value': '32.3', 'spread': '8.3', 'groupId': 'OG000'}]}]}, {'title': 'mean SF12 Mental Preoperative (N=217)', 'categories': [{'measurements': [{'value': '49.1', 'spread': '11.99', 'groupId': 'OG000'}]}]}, {'title': 'Mean SF12 Physical 2 years (N=175)', 'categories': [{'measurements': [{'value': '45.6', 'spread': '11.17', 'groupId': 'OG000'}]}]}, {'title': 'Mean SF12 Mental 2 years (N=175)', 'categories': [{'measurements': [{'value': '54.2', 'spread': '8.41', 'groupId': 'OG000'}]}]}, {'title': 'Mean SF-12 Physical 5 years (N=121)', 'categories': [{'measurements': [{'value': '44.8', 'spread': '10.62', 'groupId': 'OG000'}]}]}, {'title': 'Mean SF-12 Mental 5 years (N=121)', 'categories': [{'measurements': [{'value': '53.4', 'spread': '9.45', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000'], 'groupDescription': 'Compare Pre-op SF-12 Physical Score preop to 2 year and preop to 5 year', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<.0001', 'groupIds': ['OG000'], 'groupDescription': 'Change in SF-12 Mental Score preop to 2 years', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '.0004', 'groupIds': ['OG000'], 'groupDescription': 'Compare SF-12 Mental Score preop to 5 years', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Preoperative, 2 and 5 years', 'description': 'The change in SF-12 is reported by comparing the mean preoperative, 2 and 5 year postoperative scores.The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hips', 'denomUnitsSelected': 'hips', 'populationDescription': 'Participants with available data: A total of 217 hips had preoperative scores, 175 had 2 year and 121 had 5 year scores.'}, {'type': 'SECONDARY', 'title': 'Change in Lower Extremity Activity Scale (LEAS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '231', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Accolade® TMZF® Hip Stem', 'description': 'Subjects who received the Accolade® TMZF® Hip Stem'}], 'classes': [{'title': 'Mean LEAS Preoperative (n=231)', 'categories': [{'measurements': [{'value': '8.4', 'spread': '3.32', 'groupId': 'OG000'}]}]}, {'title': 'Mean LEAS 2 year (N=181)', 'categories': [{'measurements': [{'value': '10.4', 'spread': '3.18', 'groupId': 'OG000'}]}]}, {'title': 'Mean LEAS 5 year (N=129)', 'categories': [{'measurements': [{'value': '10.2', 'spread': '3.34', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000'], 'groupDescription': 'Compare LEAS score preop to 2 years and preop to 5 years', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Preoperative, 2 and 5 years', 'description': 'The change in LEAS is reported by comparing the mean preoperative, 2 and 5 year postoperative scores.The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. The mean preoperative, 2 and 5 year scores are reported to assess improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hips', 'denomUnitsSelected': 'hips', 'populationDescription': 'Participants with available data: A total of 231 hips had a preoperative score, 181 had a 2 year, and 129 had a 5 year score.'}, {'type': 'SECONDARY', 'title': 'PEQ (Patient Expectation Questionnaire) Overall Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '206', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Accolade® TMZF® Hip Stem', 'description': 'Subjects who received the Accolade® TMZF® Hip Stem'}], 'classes': [{'title': 'Recreation 6 mo (n=97)', 'categories': [{'measurements': [{'value': '84.5', 'groupId': 'OG000'}]}]}, {'title': 'Recreation 1 yr (n=95)', 'categories': [{'measurements': [{'value': '88.4', 'groupId': 'OG000'}]}]}, {'title': 'Recreation 2 yr (n=76)', 'categories': [{'measurements': [{'value': '85.5', 'groupId': 'OG000'}]}]}, {'title': 'Exercise/sports 6 mo (n=79)', 'categories': [{'measurements': [{'value': '89.9', 'groupId': 'OG000'}]}]}, {'title': 'Exercise/sports 1 yr (n=79)', 'categories': [{'measurements': [{'value': '89.9', 'groupId': 'OG000'}]}]}, {'title': 'Exercise/sports 2 yr (n=67)', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}]}]}, {'title': 'Chores 6 mo (n=71)', 'categories': [{'measurements': [{'value': '91.5', 'groupId': 'OG000'}]}]}, {'title': 'Chores 1 yr (n=65)', 'categories': [{'measurements': [{'value': '86.2', 'groupId': 'OG000'}]}]}, {'title': 'Chores 2 yr (n=58)', 'categories': [{'measurements': [{'value': '96.6', 'groupId': 'OG000'}]}]}, {'title': 'Change position 6 mo (n=57)', 'categories': [{'measurements': [{'value': '87.7', 'groupId': 'OG000'}]}]}, {'title': 'Change position 1 yr (n=58)', 'categories': [{'measurements': [{'value': '87.9', 'groupId': 'OG000'}]}]}, {'title': 'Change position 2 yr (n=43)', 'categories': [{'measurements': [{'value': '90.7', 'groupId': 'OG000'}]}]}, {'title': 'No cane/crutch/walker 6 mo (n=57)', 'categories': [{'measurements': [{'value': '94.7', 'groupId': 'OG000'}]}]}, {'title': 'No cane/crutch/walker 1 yr (n=53)', 'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000'}]}]}, {'title': 'No cane/crutch/walker 2 yr (n=49)', 'categories': [{'measurements': [{'value': '93.9', 'groupId': 'OG000'}]}]}, {'title': 'Stairs normally 6 mo (n=52)', 'categories': [{'measurements': [{'value': '80.8', 'groupId': 'OG000'}]}]}, {'title': 'Stairs normally 1 yr (n=58)', 'categories': [{'measurements': [{'value': '86.2', 'groupId': 'OG000'}]}]}, {'title': 'Stairs normally 2 yr (n=45)', 'categories': [{'measurements': [{'value': '91.1', 'groupId': 'OG000'}]}]}, {'title': 'Sleep 6 mo (n=52)', 'categories': [{'measurements': [{'value': '71.2', 'groupId': 'OG000'}]}]}, {'title': 'Sleep 1 yr (n=49)', 'categories': [{'measurements': [{'value': '77.6', 'groupId': 'OG000'}]}]}, {'title': 'Sleep 2 yr (n=51)', 'categories': [{'measurements': [{'value': '84.3', 'groupId': 'OG000'}]}]}, {'title': 'Maintain activities 6 mo (n=44)', 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000'}]}]}, {'title': 'Maintain activities 1 yr (n=41)', 'categories': [{'measurements': [{'value': '87.8', 'groupId': 'OG000'}]}]}, {'title': 'Maintain activities 2 yr (n=38)', 'categories': [{'measurements': [{'value': '94.7', 'groupId': 'OG000'}]}]}, {'title': 'Transportation 6 mo (n=27)', 'categories': [{'measurements': [{'value': '96.3', 'groupId': 'OG000'}]}]}, {'title': 'Transportation 1 yr (n=29)', 'categories': [{'measurements': [{'value': '96.6', 'groupId': 'OG000'}]}]}, {'title': 'Transportation 2 yr (n=24)', 'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000'}]}]}, {'title': 'Well-being 6 mo (n=21)', 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000'}]}]}, {'title': 'Well-being 1 yr (n=20)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}]}]}, {'title': 'Well-being 2 yr (n=15)', 'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG000'}]}]}, {'title': 'Sexual activity 6 mo (n=15)', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'Sexual activity 1 yr (n=13)', 'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000'}]}]}, {'title': 'Sexual activity 2 yr (n=12)', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}]}]}, {'title': 'Employment 6 mo (n=12)', 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000'}]}]}, {'title': 'Employment 1 yr (n=11)', 'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000'}]}]}, {'title': 'Employment 2 yr (n=8)', 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months, 1 year and 2 years', 'description': 'The PEQ is a study sponsor generated outcomes form. It is a one page questionnaire completed by the participant to assess lifestyle recovery post-surgery. Preoperatively, participants are asked to identify 3 of 12 different expectations that they most want to achieve after hip surgery. At 6 months,1 year and 2 years post-surgery participants evaluated the 3 expectations they identified and assessed their overall satisfaction and percent achievement.\n\nEXPECTATIONS KEY:\n\nParticipate in recreational activities (dancing,traveling,gardening)\n\nExercise or participate in sports\n\nIndependently perform household chores/daily routine\n\nEasily change position,sit to stand/stand to sit\n\nRemove need for cane crutch or walker\n\nUse stairs normally step by step\n\nAbility to sleep through night\n\nMaintain social activites,caring for someone,playing with children\n\nUse public transportation or drive\n\nMaintain psychological well-being\n\nMaintain sexual activity\n\nMaintain employment', 'unitOfMeasure': 'percentage of particpants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hips', 'denomUnitsSelected': 'hips', 'populationDescription': 'Participants with available data: A total of 206 hips had 6 month data; a total of 203 hips had 1 year data; a total of 178 hips had 2 year data. Percentage of participants who were satisfied with the result is reported for each expectation at these intervals.'}, {'type': 'SECONDARY', 'title': 'PEQ (Patient Evaluation Questionnaire) Percent Achievement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '206', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Accolade® TMZF® Hip Stem', 'description': 'Subjects who received the Accolade® TMZF® Hip Stem'}], 'classes': [{'title': 'Recreation 100% 6 mo (n=101)', 'categories': [{'measurements': [{'value': '42.6', 'groupId': 'OG000'}]}]}, {'title': 'Recreation 100% 1 yr (n=97)', 'categories': [{'measurements': [{'value': '55.7', 'groupId': 'OG000'}]}]}, {'title': 'Recreation 100% 2 yr (n=83)', 'categories': [{'measurements': [{'value': '47.0', 'groupId': 'OG000'}]}]}, {'title': 'Recreation 75% 6 mo (n=101)', 'categories': [{'measurements': [{'value': '33.7', 'groupId': 'OG000'}]}]}, {'title': 'Recreation 75% 1 yr (n=97)', 'categories': [{'measurements': [{'value': '28.9', 'groupId': 'OG000'}]}]}, {'title': 'Recreation 75% 2 yr (n=83)', 'categories': [{'measurements': [{'value': '28.9', 'groupId': 'OG000'}]}]}, {'title': 'Recreation 50% 6 mo (n=101)', 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000'}]}]}, {'title': 'Recreation 50% 1 yr (n=97)', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}]}]}, {'title': 'Recreation 50% 2 yr (n=83)', 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000'}]}]}, {'title': 'Recreation 25% 6 mo (n=101)', 'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000'}]}]}, {'title': 'Recreation 25% 1 yr (n=97)', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}]}]}, {'title': 'Recreation 25% 2 yr (n=83)', 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000'}]}]}, {'title': 'Recreation 0% 6 mo (n=101)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'Recreation 0% 1 yr (n=97)', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}]}]}, {'title': 'Recreation 0% 2 yr (n=83)', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}]}]}, {'title': 'Exercise/sports 100% 6 mo (n=81)', 'categories': [{'measurements': [{'value': '43.2', 'groupId': 'OG000'}]}]}, {'title': 'Exercise/sports 100% 1 yr (n=82)', 'categories': [{'measurements': [{'value': '51.2', 'groupId': 'OG000'}]}]}, {'title': 'Exercise/sports 100% 2 yr (n=74)', 'categories': [{'measurements': [{'value': '44.6', 'groupId': 'OG000'}]}]}, {'title': 'Exercise/sports 75% 6 mo (n=81)', 'categories': [{'measurements': [{'value': '37.0', 'groupId': 'OG000'}]}]}, {'title': 'Exercise/sports 75% 1 yr (n=82)', 'categories': [{'measurements': [{'value': '29.3', 'groupId': 'OG000'}]}]}, {'title': 'Exercise/sports 75% 2 yr (n=74)', 'categories': [{'measurements': [{'value': '32.4', 'groupId': 'OG000'}]}]}, {'title': 'Exercise/sports 50% 6 mo (n=81)', 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000'}]}]}, {'title': 'Exercise/sports 50% 1 yr (n=82)', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}]}]}, {'title': 'Exercise/sports 50% 2 yr (n=74)', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}]}]}, {'title': 'Exercise/sports 25% 6 mo (n=81)', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}]}]}, {'title': 'Exercise/sports 25% 1 yr (n=82)', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000'}]}]}, {'title': 'Exercise/sports 25% 2 yr (n=74)', 'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000'}]}]}, {'title': 'Exercise/sports 0% 6 mo (n=81)', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}]}]}, {'title': 'Exercise/sports 0% 1 yr (n=82)', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Exercise/sports 0% 2 yr (n=74)', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}]}]}, {'title': 'Chores 100% 6 mo (n=74)', 'categories': [{'measurements': [{'value': '71.6', 'groupId': 'OG000'}]}]}, {'title': 'Chores 100% 1 yr (n=72)', 'categories': [{'measurements': [{'value': '65.3', 'groupId': 'OG000'}]}]}, {'title': 'Chores 100% 2 yr (n=65)', 'categories': [{'measurements': [{'value': '58.5', 'groupId': 'OG000'}]}]}, {'title': 'Chores 75% 6 mos (n=74)', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}]}]}, {'title': 'Chores 75% 1 yr (n=72)', 'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000'}]}]}, {'title': 'Chores 75% 2 yr (n=65)', 'categories': [{'measurements': [{'value': '27.7', 'groupId': 'OG000'}]}]}, {'title': 'Chores 50% 6 mo (n=74)', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}]}]}, {'title': 'Chores 50% 1 yr (n=72)', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}]}]}, {'title': 'Chores 50% 2 yr (n=65)', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}]}]}, {'title': 'Chores 25% 6 mo (n=74)', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}]}]}, {'title': 'Chores 25% 1 yr (n=72)', 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000'}]}]}, {'title': 'Chores 25% 2 yr (n=65)', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}]}]}, {'title': 'Chores 0% 6 mo (n=74)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Chores 0% 1 yr (n=72)', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'Chores 0% 2 yr (n=65)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change position 100% 6 mo (n=63)', 'categories': [{'measurements': [{'value': '58.7', 'groupId': 'OG000'}]}]}, {'title': 'Change position 100% 1 yr (n=61)', 'categories': [{'measurements': [{'value': '60.7', 'groupId': 'OG000'}]}]}, {'title': 'Change position 100% 2 yr (n=49)', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}]}]}, {'title': 'Change position 75% 6 mo (n=63)', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}]}]}, {'title': 'Change position 75% 1 yr (n=61)', 'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000'}]}]}, {'title': 'Change position 75% 2 yr (n=49)', 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000'}]}]}, {'title': 'Change position 50% 6 mo (n=63)', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}]}]}, {'title': 'Change position 50% 1 yr (n=61)', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}]}]}, {'title': 'Change position 50% 2 yr (n=49)', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}]}]}, {'title': 'Change position 25% 6 mo (n=63)', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}]}]}, {'title': 'Change position 25% 1 yr (n=61)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change position 25% 2 yr (n=49)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'Change position 0% 6 mo (n=63)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change position 0% 1 yr (n=61)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change position 0% 2 yr (n=49)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'No cane/crutch/walker 100% 6 mo (n=58)', 'categories': [{'measurements': [{'value': '79.3', 'groupId': 'OG000'}]}]}, {'title': 'No cane/crutch/walker 100% 1 yr (n=54)', 'categories': [{'measurements': [{'value': '79.6', 'groupId': 'OG000'}]}]}, {'title': 'No cane/crutch/walker 100% 2 yr (n=53)', 'categories': [{'measurements': [{'value': '77.4', 'groupId': 'OG000'}]}]}, {'title': 'No cane/crutch/walker 75% 6 mo (n=58)', 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000'}]}]}, {'title': 'No cane/crutch/walker 75% 1 yr (n=54)', 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}]}]}, {'title': 'No cane/crutch/walker 75% 2 yr (n=53)', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000'}]}]}, {'title': 'No cane/crutch/walker 50% 6 mo (n=58)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'No cane/crutch/walker 50% 1 yr (n=54)', 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}]}]}, {'title': 'No cane/crutch/walker 50% 2 yr (n=53)', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000'}]}]}, {'title': 'No cane/crutch/walker 25% 6 mo (n=58)', 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000'}]}]}, {'title': 'No cane/crutch/walker 25% 1 yr (n=54)', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}]}]}, {'title': 'No cane/crutch/walker 25% 1 yr (n=53)', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}]}]}, {'title': 'No cane/crutch/walker 0% 6 mo (n=58)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'No cane/crutch/walker 0% 1 yr (n=54)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'No cane/crutch/walker 0% 2 yr (n=53)', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}]}]}, {'title': 'Stairs normally 100% 6 mo (n=56)', 'categories': [{'measurements': [{'value': '51.8', 'groupId': 'OG000'}]}]}, {'title': 'Stairs normally 100% 1 yr (n=59)', 'categories': [{'measurements': [{'value': '62.7', 'groupId': 'OG000'}]}]}, {'title': 'Stairs normally 100% 2 yr (n=47)', 'categories': [{'measurements': [{'value': '55.3', 'groupId': 'OG000'}]}]}, {'title': 'Stairs normally 75% 6 mo (n=56)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Stairs normally 75% 1 yr (n=59)', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}]}]}, {'title': 'Stairs normally 75% 2 yr (n=47)', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000'}]}]}, {'title': 'Stairs normally 50% 6 mo (n=56)', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}]}]}, {'title': 'Stairs normally 50% 1 yr (n=59)', 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}]}]}, {'title': 'Stairs normally 50% 2 yr (n=47)', 'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000'}]}]}, {'title': 'Stairs normally 25% 6 mo (n=56)', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}]}]}, {'title': 'Stairs normally 25% 1 yr (n=59)', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000'}]}]}, {'title': 'Stairs normally 25% 2 yr (n=47)', 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000'}]}]}, {'title': 'Stairs normally 0% 6 mo (n=56)', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}]}]}, {'title': 'Stairs normally 0% 1 yr (n=59)', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}]}]}, {'title': 'Stairs normally 0% 2 yr (n=47)', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000'}]}]}, {'title': 'Sleep 100% 6 mo (n=55)', 'categories': [{'measurements': [{'value': '43.6', 'groupId': 'OG000'}]}]}, {'title': 'Sleep 100% 1 yr (n=53)', 'categories': [{'measurements': [{'value': '39.6', 'groupId': 'OG000'}]}]}, {'title': 'Sleep 100% 2 yr (n=51)', 'categories': [{'measurements': [{'value': '51.0', 'groupId': 'OG000'}]}]}, {'title': 'Sleep 75% 6 mo (n=55)', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'Sleep 75% 1 yr (n=53)', 'categories': [{'measurements': [{'value': '28.3', 'groupId': 'OG000'}]}]}, {'title': 'Sleep 75% 2 yr (n=51)', 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000'}]}]}, {'title': 'Sleep 50% 6 mo (n=55)', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000'}]}]}, {'title': 'Sleep 50% 1 yr (n=53)', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}]}]}, {'title': 'Sleep 50% 2 yr (n=51)', 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000'}]}]}, {'title': 'Sleep 25% 6 mo (n=55)', 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000'}]}]}, {'title': 'Sleep 25% 1 yr (n=53)', 'categories': [{'measurements': [{'value': '15.1', 'groupId': 'OG000'}]}]}, {'title': 'Sleep 25% 2 yr (n=51)', 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000'}]}]}, {'title': 'Sleep 0% 6 mo (n=55)', 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000'}]}]}, {'title': 'Sleep 0% 1 yr (n=53)', 'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000'}]}]}, {'title': 'Sleep 0% 2 yr (n=51)', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}]}]}, {'title': 'Maintain activities 100% 6 mo (n=47)', 'categories': [{'measurements': [{'value': '61.7', 'groupId': 'OG000'}]}]}, {'title': 'Maintain activities 100% 1 yr (n=44)', 'categories': [{'measurements': [{'value': '65.9', 'groupId': 'OG000'}]}]}, {'title': 'Maintain activities 100% 2 yr (n=40)', 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}]}]}, {'title': 'Maintain activities 75% 6 mo (n=47)', 'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000'}]}]}, {'title': 'Maintain activities 75% 1 yr (n=44)', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000'}]}]}, {'title': 'Maintain activities 75% 2 yr (n=40)', 'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000'}]}]}, {'title': 'Maintain activities 50% 6 mo (n=47)', 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000'}]}]}, {'title': 'Maintain activities 50% 1 yr (n=44)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Maintain activities 50% 2 yr (n=40)', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000'}]}]}, {'title': 'Maintain activities 25% 6 mo (n=47)', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}]}]}, {'title': 'Maintain activities 25% 1 yr (n=44)', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}]}]}, {'title': 'Maintain activities 25% 2 yr (n=40)', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}]}]}, {'title': 'Maintain activities 0% 6 mo (n=47)', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Maintain activities 0% 1 yr (n=44)', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}]}]}, {'title': 'Maintain activities 0% 2 yr (n=40)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Transportation 100% 6 mo (n=30)', 'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG000'}]}]}, {'title': 'Transportation 100% 1 yr (n=32)', 'categories': [{'measurements': [{'value': '90.6', 'groupId': 'OG000'}]}]}, {'title': 'Transportation 100% 2 yr (n=27)', 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000'}]}]}, {'title': 'Transportation 75% 6 mo (n=30)', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}, {'title': 'Transportation 75% 1 yr (n=32)', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}]}]}, {'title': 'Transportation 75% 2 yr (n=27)', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}]}]}, {'title': 'Transportation 50% 6 mo (n=30)', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}]}]}, {'title': 'Transportation 50% 1 yr (n=32)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Transportation 50% 2 yr (n=27)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Transportation 25% 6 mo (n=30)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Transportation 25% 1 yr (n=32)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Transportation 25% 2 yr (n=27)', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}]}]}, {'title': 'Transportation 0% 6 mo (n=30)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Transportation 0% 1 yr (n=32)', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}]}]}, {'title': 'Transportation 0% 2 yr (n=27)', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}]}]}, {'title': 'Well-being 100% 6 mo (n=22)', 'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000'}]}]}, {'title': 'Well-being 100% 1 yr (n=24)', 'categories': [{'measurements': [{'value': '58.3', 'groupId': 'OG000'}]}]}, {'title': 'Well-being 100% 2 yr (n=17)', 'categories': [{'measurements': [{'value': '47.1', 'groupId': 'OG000'}]}]}, {'title': 'Well-being 75% 6 mo (n=22)', 'categories': [{'measurements': [{'value': '31.8', 'groupId': 'OG000'}]}]}, {'title': 'Well-being 75% 1 yr (n=24)', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}, {'title': 'Well-being 75% 2 yr (n=17)', 'categories': [{'measurements': [{'value': '35.3', 'groupId': 'OG000'}]}]}, {'title': 'Well-being 50% 6 mo (n=22)', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}]}]}, {'title': 'Well-being 50% 1 yr (n=24)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Well-being 50% 2 yr (n=17)', 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000'}]}]}, {'title': 'Well-being 25% 6 mo (n=22)', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}]}]}, {'title': 'Well-being 25% 1 yr (n=24)', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}]}]}, {'title': 'Well-being 25% 2 yr (n=17)', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}]}]}, {'title': 'Well-being 0% 6 mo (n=22)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Well-being 0% 1 yr (n=24)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Well-being 0% 2 yr (n=17)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Sexual activity 100% 6 mo (n=15)', 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000'}]}]}, {'title': 'Sexual activity 100% 1 yr (n=14)', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}]}]}, {'title': 'Sexual activity 100% 2 yr (n=14)', 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000'}]}]}, {'title': 'Sexual activity 75% 6 mo (n=15)', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}, {'title': 'Sexual activity 75% 1 yr (n=14)', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}]}]}, {'title': 'Sexual activity 75% 2 yr (n=14)', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}]}]}, {'title': 'Sexual activity 50% 6 mo (n=15)', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'Sexual activity 50% 1 yr (n=14)', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}]}]}, {'title': 'Sexual activity 50% 2 yr (n=14)', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}]}]}, {'title': 'Sexual activity 25% 6 mo (n=15)', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'Sexual activity 25% 1 yr (n=14)', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}]}]}, {'title': 'Sexual activity 25% 2 yr (n=14)', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}]}]}, {'title': 'Sexual activity 0% 6 mo (n=15)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Sexual activity 0% 1 yr (n=14)', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}]}]}, {'title': 'Sexual activity 0% 2 yr (n=14)', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}]}]}, {'title': 'Employment 100% 6 mo (n=12)', 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000'}]}]}, {'title': 'Employment 100% 1 yr (n=12)', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}]}]}, {'title': 'Employment 100% 2 yr (n=9)', 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000'}]}]}, {'title': 'Employment 75% 6 mo (n=12)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Employment 75% 1 yr (n=12)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Employment 75% 2 yr (n=9)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Employment 50% 6 mo (n=12)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Employment 50% 1 yr (n=12)', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}]}]}, {'title': 'Employment 50% 2 yr (n=9)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Employment 25% 6 mo (n=12)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Employment 25% 1 yr (n=12)', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}]}]}, {'title': 'Employment 25% 2 yr (n=9)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Employment 0% 6 mo (n=12)', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}]}]}, {'title': 'Employment 0% 1 yr (n=12)', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}]}]}, {'title': 'Employment 0% 2 yr (n=9)', 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months, 1 year, 2 years', 'description': 'The PEQ is a study sponsor generated outcomes form. It is a one page questionnaire completed by the participant to assess lifestyle recovery post-surgery. Preoperatively, participants are asked to identify 3 of 12 different expectations that they most want to achieve after hip surgery. At 6 months,1 year and 2 years post-surgery participants evaluated the 3 expectations they identified and assessed their overall satisfaction and percent achievement.\n\nEXPECTATIONS KEY:\n\nParticipate in recreational activities (dancing,traveling,gardening)\n\nExercise or participate in sports\n\nIndependently perform household chores/daily routine\n\nEasily change position,sit to stand/stand to sit\n\nRemove need for cane crutch or walker\n\nUse stairs normally step by step\n\nAbility to sleep through night\n\nMaintain social activites,caring for someone,playing with children\n\nUse public transportation or drive\n\nMaintain psychological well-being\n\nMaintain sexual activity\n\nMaintain employment', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hips', 'denomUnitsSelected': 'hips', 'populationDescription': 'Participants with available data: A total of 206 hips had 6 month data; a total of 203 hips had 1 year data; a total of 178 hips had 2 year data. Participants select 3 expectations and assess percent achievement (100%,75%,50%,25%,or 0%) at 6 mos, 1 yr and 2 yrs.'}, {'type': 'SECONDARY', 'title': 'Acetabular Insert Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Accolade® TMZF® Hip Stem', 'description': 'Subjects who received the Accolade® TMZF® Hip Stem'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0342', 'spread': '0.0336', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000'], 'groupDescription': 'Compare to historical control (n=94 hips): mean wear 5 years = 0.134 (0.078)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'The linear wear rate of the polyethylene acetabular insert is measured radiographically and reported at 5 years.', 'unitOfMeasure': 'millimeters per year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hips', 'denomUnitsSelected': 'hips', 'populationDescription': 'Participants with available data: 97 hips were evaluated for wear rate at 5 years.'}, {'type': 'SECONDARY', 'title': 'Wrist DXA Scan Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Accolade® TMZF® Hip Stem', 'description': 'Subjects who received the Accolade® TMZF® Hip Stem'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.05', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.0002', 'groupIds': ['OG000'], 'groupDescription': 'Compare Wrist DXA T-score preop to 5 years', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'DXA is a bone densitometry scan that measures bone mineral density and assigns a T-score. This score shows the amount of bone a patient has compared with a young adult of the same gender with peak bone mass. A score above -1 is considered normal. A score between -1 and -2.5 is classified as osteopenia (low bone mass). A score below -2.5 is defined as osteoporosis.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hips', 'denomUnitsSelected': 'hips', 'populationDescription': 'Participants with available data: 107 hips had DXA scan T-scores at 5 years.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Accolade® TMZF® Hip Stem', 'description': 'Accolade® TMZF® Hip Stem Study Device. Participants have one or both hips replaced. If both hips were replaced, but only one hip completed the primary endpoint, the participant is counted as completed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '234'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed/Not completed counts are based on participant status at the 2yr primary outcome interval.', 'groupId': 'FG000', 'numSubjects': '169'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Revision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Incomplete 2 yr data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'Site termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'unwilling/unable to return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'surgery cancelled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': '241 participants/249 hips - 7 censored participants/7 hips = 234 participants/242 hips'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Accolade® TMZF® Hip Stem', 'description': 'Accolade® TMZF® Hip Stem Study Device'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.94', 'spread': '9.77', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': '1. Age results are based on 226 participants as there were 8 participants missing age data.\n2. For bilateral total hip replacement participants, the age at the time of the initial hip surgery is used.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Gender is based on 229 participants as there were 5 participants missing gender data.', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '234', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Participants who were censored protocol violations or who were enrolled but did not have surgery or age data was not available, are not included in the baseline analysis.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 241}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-07', 'studyFirstSubmitDate': '2009-08-10', 'resultsFirstSubmitDate': '2013-10-28', 'studyFirstSubmitQcDate': '2009-08-11', 'lastUpdatePostDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-08-13', 'studyFirstPostDateStruct': {'date': '2009-08-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Percentage (%) of Hip Stems With Aseptic Loosening', 'timeFrame': '5 years', 'description': 'Aseptic loosening is defined as a continuous radiolucency that surrounds the entire femoral stem porous coating-bone interface and that measures greater than 2 mm in thickness, and 5 mm or more of stem subsidence. Continuous radiolucency must be present in Zones 1, 2, 6 and 7 of the AP radiographic view and/or present in Zones 8, 9, 13 and 14 of the M/L radiographic view.'}, {'measure': 'Revision/Removal Rates', 'timeFrame': '2 and 5 years', 'description': 'The percentage (%) of hips with revision or removal of any total hip replacement component (acetabular cup, femoral stem or femoral head) is reported at the 2 and 5 year postoperative intervals.'}, {'measure': 'Change in Harris Hip Score (HHS)', 'timeFrame': 'Preoperative, 2 and 5 years', 'description': 'The change in HHS is reported by comparing the mean preoperative, 2 and 5 year postoperative scores. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent, 80-89 = good, 70-79 = fair, 0-69 = poor.'}, {'measure': 'Change in SF-12 Score', 'timeFrame': 'Preoperative, 2 and 5 years', 'description': 'The change in SF-12 is reported by comparing the mean preoperative, 2 and 5 year postoperative scores.The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.'}, {'measure': 'Change in Lower Extremity Activity Scale (LEAS) Score', 'timeFrame': 'Preoperative, 2 and 5 years', 'description': 'The change in LEAS is reported by comparing the mean preoperative, 2 and 5 year postoperative scores.The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. The mean preoperative, 2 and 5 year scores are reported to assess improvement.'}, {'measure': 'PEQ (Patient Expectation Questionnaire) Overall Satisfaction', 'timeFrame': '6 months, 1 year and 2 years', 'description': 'The PEQ is a study sponsor generated outcomes form. It is a one page questionnaire completed by the participant to assess lifestyle recovery post-surgery. Preoperatively, participants are asked to identify 3 of 12 different expectations that they most want to achieve after hip surgery. At 6 months,1 year and 2 years post-surgery participants evaluated the 3 expectations they identified and assessed their overall satisfaction and percent achievement.\n\nEXPECTATIONS KEY:\n\nParticipate in recreational activities (dancing,traveling,gardening)\n\nExercise or participate in sports\n\nIndependently perform household chores/daily routine\n\nEasily change position,sit to stand/stand to sit\n\nRemove need for cane crutch or walker\n\nUse stairs normally step by step\n\nAbility to sleep through night\n\nMaintain social activites,caring for someone,playing with children\n\nUse public transportation or drive\n\nMaintain psychological well-being\n\nMaintain sexual activity\n\nMaintain employment'}, {'measure': 'PEQ (Patient Evaluation Questionnaire) Percent Achievement', 'timeFrame': '6 months, 1 year, 2 years', 'description': 'The PEQ is a study sponsor generated outcomes form. It is a one page questionnaire completed by the participant to assess lifestyle recovery post-surgery. Preoperatively, participants are asked to identify 3 of 12 different expectations that they most want to achieve after hip surgery. At 6 months,1 year and 2 years post-surgery participants evaluated the 3 expectations they identified and assessed their overall satisfaction and percent achievement.\n\nEXPECTATIONS KEY:\n\nParticipate in recreational activities (dancing,traveling,gardening)\n\nExercise or participate in sports\n\nIndependently perform household chores/daily routine\n\nEasily change position,sit to stand/stand to sit\n\nRemove need for cane crutch or walker\n\nUse stairs normally step by step\n\nAbility to sleep through night\n\nMaintain social activites,caring for someone,playing with children\n\nUse public transportation or drive\n\nMaintain psychological well-being\n\nMaintain sexual activity\n\nMaintain employment'}, {'measure': 'Acetabular Insert Wear', 'timeFrame': '5 years', 'description': 'The linear wear rate of the polyethylene acetabular insert is measured radiographically and reported at 5 years.'}, {'measure': 'Wrist DXA Scan Analysis', 'timeFrame': '5 years', 'description': 'DXA is a bone densitometry scan that measures bone mineral density and assigns a T-score. This score shows the amount of bone a patient has compared with a young adult of the same gender with peak bone mass. A score above -1 is considered normal. A score between -1 and -2.5 is classified as osteopenia (low bone mass). A score below -2.5 is defined as osteoporosis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoarthritis'], 'conditions': ['Arthroplasty, Replacement, Hip']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate clinical and radiographic outcome data in patients implanted with the Accolade® TMZF® femoral stem.', 'detailedDescription': 'A prospective, post-market, multi-centered clinical evaluation of the Accolade® TMZF® hip stem device. All patients enrolled will receive the study device. All study patients will undergo a preoperative central Dual energy X-ray absorptiometry (DXA) scan to determine bone mineral density (BMD) values.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient is a candidate for a primary total hip replacement.\n2. Patient has primary diagnosis of osteoarthritis (OA).\n3. Male and non-pregnant female patients ages 18 to 90.\n4. Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.\n5. Patient willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.\n6. Patient capable of undergoing a pre-op central DXA (dual-energy x-ray absorptiometry) scan for a bone mineral density (BMD) reading.\n\nExclusion Criteria:\n\n1. Patient has an active infection within the affected hip joint.\n2. Patient requires a revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.\n3. Patient who is morbidly obese, Body Mass Index (BMI) \\> 40.\n4. Patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.\n5. Patient has the following diagnosed systemic diseases: Paget's disease, renal osteodystrophy, lupus erythematosus, rheumatoid arthritis, metabolic bone disease and sickle cell anemia.\n6. Patient is immunologically suppressed or receiving chronic steroids more than 30 days. Patients receiving oral or IV steroids within one month of surgery.\n7. Patient is a prisoner."}, 'identificationModule': {'nctId': 'NCT00957658', 'briefTitle': 'Accolade® TMZF® Hip Stem Outcomes Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stryker Orthopaedics'}, 'officialTitle': 'Accolade® TMZF® Study A Prospective, Post-market, Non-randomized, Multi-center Evaluation of the Accolade® TMZF® Hip Stem', 'orgStudyIdInfo': {'id': '59'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Accolade® TMZF® Hip Stem', 'description': 'Accolade® TMZF® Hip Stem Study Device', 'interventionNames': ['Device: Accolade® TMZF® Hip Stem']}], 'interventions': [{'name': 'Accolade® TMZF® Hip Stem', 'type': 'DEVICE', 'description': 'Accolade® TMZF® Hip Stem', 'armGroupLabels': ['Accolade® TMZF® Hip Stem']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Newport Orthopaedic Institute', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Alvarado Ortho Medical Group', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33435', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Orthopaedic Surgery Associates', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '34209', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Coastal Orthopaedics', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '31908', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Hughston Clinic P.A.', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '02332', 'city': 'Duxbury', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Plymouth Bay Ortho Association', 'geoPoint': {'lat': 42.04177, 'lon': -70.67226}}, {'zip': '01107', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'New England Orthopaedic Surgeons', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '10528', 'city': 'Harrison', 'state': 'New York', 'country': 'United States', 'facility': 'Specialty Orthopaedics', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '23907', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Spartanburg Regional Medical Center', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '98402', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Orthopaedic Institute', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'Robert Krushell, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Baystate Medical Center'}, {'name': 'Carlton Savory, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hughston Sports Medicine Center'}, {'name': 'Robert Zann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boca Raton Community Hospital'}, {'name': 'Steven Gausewitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hoag Hospital'}, {'name': 'R. Scott Oliver, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jordan Hospital'}, {'name': "Mary O'Connor, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}, {'name': 'Anthony Sanchez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spartanburg Regional Health Service District, Inc'}, {'name': 'Mark Visk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spartanburg Regional Health Service District, Inc'}, {'name': 'Steven Teeny, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Clare Hospital'}, {'name': 'Alan Valadie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Coastal Orthopedics and Sports Medicine'}, {'name': 'Steven Zelicof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sound Shore Medical Center of Westchester'}, {'name': 'James Bates, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alvarado Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stryker Orthopaedics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}