Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-01-01 @ 8:13 PM
Study NCT ID:
NCT01257568
Status:
COMPLETED
Last Update Posted:
2022-02-16
First Post:
2010-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rejuvenate Modular Outcomes Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shaherah.yancy@stryker.com', 'phone': '901-650-6601', 'title': 'Shaherah Yancy, Director, Clinical Operations', 'organization': 'Stryker Orthopaedics'}, 'certainAgreement': {'otherDetails': "Each investigator shall have privileges for their own center's results. These manuscripts and abstracts will be delayed until after the 5-year 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}, 'limitationsAndCaveats': {'description': 'Primary Outcome Note: Due to the large number of terminations and halting enrollment early in the study, the primary endpoint analysis will not be performed.'}}, 'adverseEventsModule': {'timeFrame': 'To 10 years postoperative. All AEs that meet the definition of serious, excluding elective procedures, and all AEs related to the operative site, regardless of seriousness.', 'description': 'Censored were not included as at risk.', 'eventGroups': [{'id': 'EG000', 'title': 'Operative Adverse Events', 'description': 'Rejuvenate Modular Stem/Neck. Operative site events are reported by hip because in the case of bilateral participants (this is when one participant has both hips enrolled in the study), an event can occur in one hip, both hips or the same hip at different times and are counted separately for this reason.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 9, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 25}, {'id': 'EG001', 'title': 'Non-Operative Adverse Events', 'description': 'Rejuvenate Modular Stem/Neck. Non-operative site events are reported by participant.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 7, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Operative Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Operative Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Systemic Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Operative Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Operative Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Operative Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Operative Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Systemic Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Systemic Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Systemic Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Systemic Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Systemic Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Survival Rate of the Rejuvenate Modular Stem/Neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rejuvenate Modular Hip System', 'description': 'Rejuvenate Modular Hip\n\nRejuvenate Modular Hip: Rejuvenate Modular Hip'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years postoperative', 'description': 'The success rate is defined as freedom from Rejuvenate Modular femoral stem/neck construct revision/removal for any reason.', 'unitOfMeasure': 'Surviving Hips', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Hips', 'denomUnitsSelected': 'Hips'}, {'type': 'SECONDARY', 'title': 'Biomechanical Measurement of Femoral Offset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rejuvenate Modular Hip System', 'description': 'Rejuvenate Modular Hip\n\nRejuvenate Modular Hip: Rejuvenate Modular Hip'}], 'classes': [{'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-41', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'description': 'Change from Preoperative Natural Femoral Offset to Postoperative Femoral Offset at 6-weeks postoperative measured in millimeters.', 'unitOfMeasure': 'mm', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Hips', 'denomUnitsSelected': 'Hips', 'populationDescription': 'The data presented on these 41 hips is likely inaccurate due to issues and variations in data collection.'}, {'type': 'SECONDARY', 'title': 'Biomechanical Measurement of the Vertical Distance of the Planned Hip Center of Rotation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rejuvenate Modular Hip System', 'description': 'Rejuvenate Modular Hip\n\nRejuvenate Modular Hip: Rejuvenate Modular Hip'}], 'classes': [{'categories': [{'measurements': [{'value': '-4', 'groupId': 'OG000', 'lowerLimit': '-38', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'description': 'Change from preoperative vertical distance of the anatomic hip center to the planned center of rotation of the hip to the postoperative distance from the planned center of rotation at 6 weeks measured in millimeters.', 'unitOfMeasure': 'mm', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The data presented on these 5 hips is likely inaccurate due to issues and variations in data collection.'}, {'type': 'SECONDARY', 'title': 'Biomechanical Measurement of the Horizontal Distance of the Planned Hip Center of Rotation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rejuvenate Modular Hip System', 'description': 'Rejuvenate Modular Hip\n\nRejuvenate Modular Hip: Rejuvenate Modular Hip'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'description': 'Change from preoperative horizontal distance of the anatomic hip center to the planned center of rotation of the hip to the postoperative distance from the planned center of rotation at 6 weeks measured in millimeters.', 'unitOfMeasure': 'mm', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The data presented on these 5 hips is likely inaccurate due to issues and variations in data collection.'}, {'type': 'SECONDARY', 'title': 'Mean Harris Hip Score at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rejuvenate Modular Hip System', 'description': 'Participants who received the Rejuvenate Modular stem/neck.'}], 'classes': [{'title': 'HHS Mean Preoperative Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.48', 'spread': '9.88', 'groupId': 'OG000'}]}]}, {'title': 'HHS Mean 6 Week Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '69.88', 'spread': '12.97', 'groupId': 'OG000'}]}]}, {'title': 'HHS Mean 1 Year Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94.25', 'spread': '7.65', 'groupId': 'OG000'}]}]}, {'title': 'HHS Mean 2 Year Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.92', 'spread': '11.49', 'groupId': 'OG000'}]}]}, {'title': 'HHS Mean 3 Year Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.83', 'spread': '11.71', 'groupId': 'OG000'}]}]}, {'title': 'HHS Mean 4 Year Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.82', 'spread': '15.65', 'groupId': 'OG000'}]}]}, {'title': 'HHS Mean 5 Year Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.88', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'HHS Mean 7 Year Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.00', 'spread': '7.38', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year', 'description': 'The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. 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.\n\n90-100 = 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/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.'}, {'type': 'SECONDARY', 'title': 'Mean SF-12 Scores at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rejuvenate Modular Hip System', 'description': 'Participants who received the Rejuvenate Modular stem/neck.'}], 'classes': [{'title': 'Mean SF-12 Physical Score Preoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.26', 'spread': '8.33', 'groupId': 'OG000'}]}]}, {'title': 'Mean SF-12 Physical Score 6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.07', 'spread': '7.72', 'groupId': 'OG000'}]}]}, {'title': 'Mean SF-12 Physical Score 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51.98', 'spread': '7.34', 'groupId': 'OG000'}]}]}, {'title': 'Mean SF-12 Physical Score 2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.83', 'spread': '12.06', 'groupId': 'OG000'}]}]}, {'title': 'Mean SF-12 Physical Score 3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.15', 'spread': '9.3', 'groupId': 'OG000'}]}]}, {'title': 'Mean SF-12 Physical Score 4 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49.04', 'spread': '10.55', 'groupId': 'OG000'}]}]}, {'title': 'Mean SF-12 Physical Score 5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.61', 'spread': '5.4', 'groupId': 'OG000'}]}]}, {'title': 'Mean SF-12 Physical Score 7 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.86', 'spread': '5.62', 'groupId': 'OG000'}]}]}, {'title': 'Mean SF-12 Mental Score Preoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51.6', 'spread': '13.48', 'groupId': 'OG000'}]}]}, {'title': 'Mean SF-12 Mental Score 6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.35', 'spread': '9.37', 'groupId': 'OG000'}]}]}, {'title': 'Mean SF-12 Mental Score 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.01', 'spread': '9.26', 'groupId': 'OG000'}]}]}, {'title': 'Mean SF-12 Mental Score 2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.99', 'spread': '10.13', 'groupId': 'OG000'}]}]}, {'title': 'Mean SF-12 Mental Score 3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.47', 'spread': '10.03', 'groupId': 'OG000'}]}]}, {'title': 'Mean SF-12 Mental Score 4 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.77', 'spread': '10.99', 'groupId': 'OG000'}]}]}, {'title': 'Mean SF-12 Mental Score 5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.62', 'spread': '6.88', 'groupId': 'OG000'}]}]}, {'title': 'Mean SF-12 Mental Score 7 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58.84', 'spread': '2.68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year', 'description': '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/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.'}, {'type': 'SECONDARY', 'title': 'Mean Lower Extremity Activity Scale (LEAS) Scores at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rejuvenate Modular Hip System', 'description': 'Participants who received the Rejuvenate Modular stem/neck.'}], 'classes': [{'title': 'Mean LEAS Score Preoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.88', 'spread': '2.58', 'groupId': 'OG000'}]}]}, {'title': 'Mean LEAS Score 6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.45', 'spread': '1.53', 'groupId': 'OG000'}]}]}, {'title': 'Mean LEAS Score 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.32', 'spread': '3.05', 'groupId': 'OG000'}]}]}, {'title': 'Mean LEAS Score 2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.18', 'spread': '3.06', 'groupId': 'OG000'}]}]}, {'title': 'Mean LEAS Score 3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.85', 'spread': '2.76', 'groupId': 'OG000'}]}]}, {'title': 'Mean LEAS Score 4 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.29', 'spread': '2.93', 'groupId': 'OG000'}]}]}, {'title': 'Mean LEAS Score 5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.33', 'spread': '3.14', 'groupId': 'OG000'}]}]}, {'title': 'Mean LEAS Score 7 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.60', 'spread': '1.14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Hips', 'denomUnitsSelected': 'Hips', 'populationDescription': 'Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.'}, {'type': 'SECONDARY', 'title': 'Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rejuvenate Modular Hip System', 'description': 'Participants who received the Rejuvenate Modular stem/neck.'}], 'classes': [{'title': 'Stem Subsidence-6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Stem Migration-1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Stem Migration-2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Stem Migration-3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Stem Migration-4 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Stem Migration-5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Stem Fixation Unstable-1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Stem Fixation Unstable-2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Stem Fixation Unstable-3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Stem Fixation Unstable-4 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Stem Fixation Unstable-5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Radiographic stability-6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Radiographic stability-1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Radiographic stability-2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Radiographic stability-3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Radiographic stability-4 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Radiographic stability-5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}, {'units': 'Hips', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 wks,1,2,3,4,5 yrs', 'description': 'Radiographic stability of the stem is defined as having the following: no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire femoral component, and no radiographic indication of progressive subsidence of the femoral component of great than or equal to 5 mm. Only subsidence was measured at 6 weeks, migration and fixation are analyzed beginning at 1 year postoperative.', 'unitOfMeasure': 'Hips', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Hips', 'denomUnitsSelected': 'Hips', 'populationDescription': 'Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population. The number of hips analyzed for stem subsidence equals the number of cases with a readable AP Femur or Pelvis x-ray.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rejuvenate Modular Hip System', 'description': 'Participants who received the Rejuvenate Modular stem/neck can have one or both hips replaced. If both hips were replaced, but one hip completed the primary endpoint, the participant is counted as completed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '42', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '9', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '33', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Component Revision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}]}]}], 'typeUnitsAnalyzed': 'Hips', 'recruitmentDetails': 'Recruitment in the Rejuvenate Modular Hip Stem study was terminated early. Participants can have one or both hips replaced. If both hips were enrolled in the study and only one hip completed the primary endpoint the participant is counted as completed.', 'preAssignmentDetails': '42 participants/44 hips - 2 participants/2 hips censored = 40 participants/42 hips followed. There were 25 revisions, but one bilateral participant had one hip revised and the other hip completed the primary endpoint, this participant is counted as completed and not in the revision category.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}, {'units': 'Hips', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Rejuvenate Modular Hip System', 'description': 'All subjects who received the Rejuvenate Modular stem/neck.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '62.50', 'groupId': 'BG000', 'lowerLimit': '46', 'upperLimit': '79'}]}]}], 'paramType': 'MEAN', 'description': 'For bilateral participants, age at the time of surgery for the first hip enrolled is used for the baseline measurement', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Hips', 'populationDescription': 'Includes all participants who received the Rejuvenate Modular neck/stem and were not censored from analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2009-10-07', 'size': 3503551, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2018-04-26T15:38', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-15', 'studyFirstSubmitDate': '2010-12-08', 'resultsFirstSubmitDate': '2018-06-04', 'studyFirstSubmitQcDate': '2010-12-08', 'lastUpdatePostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-23', 'studyFirstPostDateStruct': {'date': '2010-12-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival Rate of the Rejuvenate Modular Stem/Neck', 'timeFrame': '5 years postoperative', 'description': 'The success rate is defined as freedom from Rejuvenate Modular femoral stem/neck construct revision/removal for any reason.'}], 'secondaryOutcomes': [{'measure': 'Biomechanical Measurement of Femoral Offset', 'timeFrame': '6 weeks', 'description': 'Change from Preoperative Natural Femoral Offset to Postoperative Femoral Offset at 6-weeks postoperative measured in millimeters.'}, {'measure': 'Biomechanical Measurement of the Vertical Distance of the Planned Hip Center of Rotation', 'timeFrame': '6 weeks', 'description': 'Change from preoperative vertical distance of the anatomic hip center to the planned center of rotation of the hip to the postoperative distance from the planned center of rotation at 6 weeks measured in millimeters.'}, {'measure': 'Biomechanical Measurement of the Horizontal Distance of the Planned Hip Center of Rotation', 'timeFrame': '6 weeks', 'description': 'Change from preoperative horizontal distance of the anatomic hip center to the planned center of rotation of the hip to the postoperative distance from the planned center of rotation at 6 weeks measured in millimeters.'}, {'measure': 'Mean Harris Hip Score at Each Visit', 'timeFrame': 'pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year', 'description': 'The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. 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.\n\n90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor'}, {'measure': 'Mean SF-12 Scores at Each Visit', 'timeFrame': 'pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year', 'description': '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': 'Mean Lower Extremity Activity Scale (LEAS) Scores at Each Visit', 'timeFrame': 'pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year', 'description': '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.'}, {'measure': 'Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)', 'timeFrame': '6 wks,1,2,3,4,5 yrs', 'description': 'Radiographic stability of the stem is defined as having the following: no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire femoral component, and no radiographic indication of progressive subsidence of the femoral component of great than or equal to 5 mm. Only subsidence was measured at 6 weeks, migration and fixation are analyzed beginning at 1 year postoperative.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arthroplasty, Replacement, Hip']}, 'descriptionModule': {'briefSummary': 'This study will be an evaluation of the Rejuvenate® Modular Hip System for primary total hip replacement (THR) with a cementless application in a consecutive series of patients who meet the eligibility criteria. Subjects will be evaluated for freedom of hip revision at 5 years and clinical outcomes for up to 10 years after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient has signed an IRB approved, study specific Informed Patient Consent Form.\n* Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.\n* Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).\n* Patient is a candidate for a primary cementless total hip replacement.\n* Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.\n* Patient's operative femur templates to Rejuvenate® Modular Stem size 7-12.\n\nExclusion Criteria:\n\n* Patient has a Body Mass Index (BMI) ≥ 40.\n* Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.\n* Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.\n* Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.\n* Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \\> 30 days).\n* Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.\n* Patient has a known sensitivity to device materials.\n* Patient is a prisoner."}, 'identificationModule': {'nctId': 'NCT01257568', 'briefTitle': 'Rejuvenate Modular Outcomes Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stryker Orthopaedics'}, 'officialTitle': 'A Prospective, Post-market, Multi-center Study of the Outcomes of the Rejuvenate® Modular Hip System', 'orgStudyIdInfo': {'id': '68'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Rejuvenate Modular Hip System', 'description': 'Rejuvenate Modular Hip', 'interventionNames': ['Device: Rejuvenate Modular Hip']}], 'interventions': [{'name': 'Rejuvenate Modular Hip', 'type': 'DEVICE', 'description': 'Rejuvenate Modular Hip', 'armGroupLabels': ['Rejuvenate Modular Hip System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48124', 'city': 'Dearborn', 'state': 'Michigan', 'country': 'United States', 'facility': 'Oakwood Healthcare', 'geoPoint': {'lat': 42.32226, 'lon': -83.17631}}, {'zip': '56377', 'city': 'Sartell', 'state': 'Minnesota', 'country': 'United States', 'facility': 'St. Cloud Orthopaedics Associates', 'geoPoint': {'lat': 45.62163, 'lon': -94.20694}}, {'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'The Orthopedic Center', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}], 'overallOfficials': [{'name': 'Yogesh Mittal, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Orthopedic Center'}, {'name': 'Joseph Nessler, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Cloud Orthopaedic Associates'}, {'name': 'Lawrence Morawa, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oakwood Healthcare System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stryker Orthopaedics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}