Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-02-18 @ 2:41 AM
Study NCT ID:
NCT00510458
Status:
COMPLETED
Last Update Posted:
2018-03-12
First Post:
2007-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ellen.axelson@stryker.com', 'phone': '201-831-5401', 'title': 'Director, Clinical Operations', '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. Stryker's review ensures no disclosure of confidential info, no promotion of off-label use, and data is accurate.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected to the 5 year postoperative interval. Reportable AEs for this study include those that are serious or related to surgery and/or to the operative site.', 'description': 'Censored protocol deviations were not included as risk participants. Industry standard AE terms not used;specific AE terms not used for all AEs. Elective procedures not included, e.g. non-study joint replacement/revision,rotator cuff repair,carpal tunnel release,cataract,intra-ocular and bunion procedures,total shoulder repair,laminectomy, microdiscectomy,breast reduction, cervical spine fusion, mid-foot/flat-foot surgery.', 'eventGroups': [{'id': 'EG000', 'title': 'Operative Site Events', 'description': 'LFIT™ Femoral Heads With X3® Insert. 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': 78, 'otherNumAffected': 20, 'seriousNumAtRisk': 78, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Non-operative Site Events', 'description': 'LFIT™ Femoral Heads With X3® Insert. Non-operative site events are reported by participant.', 'otherNumAtRisk': 74, 'otherNumAffected': 0, 'seriousNumAtRisk': 74, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Operative Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Operative Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, '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': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-Operative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Linear Wear Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LFIT™Femoral Heads With X3® Insert', 'description': 'LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement'}], 'classes': [{'categories': [{'measurements': [{'value': '0.008', 'spread': '0.057', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'mean linear wear rate at 5 yrs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '.008', 'ciLowerLimit': '-0.0107', 'ciUpperLimit': '.0267', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'It is expected that the mean linear wear rate is not more than 0.08 mm per year or 0.05 mm per year superior to the reference control, which was 0.13 mm per year. The reference control was determined from the control group within the Post-approval Study of the ABC and Trident® Systems (NCT00960206).'}], 'paramType': 'MEAN', 'timeFrame': '5 Years Post-Surgery', 'description': 'Linear wear rate is defined as the annual rate of removal of the polyethylene from the X3 polyethylene insert mated with LFIT™ Anatomic CoCr Femoral Heads determined by comparing digitized images of serial radiographs obtained over the follow-up period.\n\n.', 'unitOfMeasure': 'mm/year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hips', 'denomUnitsSelected': 'hips', 'populationDescription': 'Participants/hips with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LFIT™Femoral Heads With X3® Insert', 'description': 'LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement'}], 'classes': [{'title': 'Mean HHS score preoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51.03', 'spread': '11.25', 'groupId': 'OG000'}]}]}, {'title': 'Mean HHS 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94.14', 'spread': '9.45', 'groupId': 'OG000'}]}]}, {'title': 'Mean HHS 3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.98', 'spread': '4.51', 'groupId': 'OG000'}]}]}, {'title': 'Mean HHS 5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.59', 'spread': '6.07', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'To test if the change from pre-operative HHS compared to the post-operative HHS at all intervals is statistically significant.'}], 'paramType': 'MEAN', 'timeFrame': 'preoperative, 1, 3, and 5 years', 'description': 'The change in HHS is reported by comparing the mean preoperative, 1, 3, and 5 year scores. The 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 hips analyzed is based upon the preoperative population.'}, {'type': 'SECONDARY', 'title': 'Change in Harris Hip Score (HHS) Pain Score From Pre-operative to Post-operative Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LFIT™Femoral Heads With X3® Insert', 'description': 'LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement'}], 'classes': [{'title': 'Mean HHS Pain score preoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.77', 'spread': '5.23', 'groupId': 'OG000'}]}]}, {'title': 'Mean HHS Pain score 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.36', 'spread': '5.14', 'groupId': 'OG000'}]}]}, {'title': 'Mean HHS Pain score 3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43.39', 'spread': '2.24', 'groupId': 'OG000'}]}]}, {'title': 'Mean HHS Pain score 5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.89', 'spread': '4.48', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'To test if the change from pre-operative HHS pain score compared to the post-operative HHS pain score at all intervals is statistically significant.'}], 'paramType': 'MEAN', 'timeFrame': 'preop, 1, 3, and 5 Years', 'description': 'This subscore of the overall HHS provides the patient with 6 possible answers to choose from ranging from, no pain/ignores it, to totally disabled/crippled/pain in bed/bedridden. A maximum of 44 points is possible for this subscore indicating no pain/ignores it.\n\nPain:\n\n1. None or ignores it = 44 points\n2. Slight, occasional, no compromise in activities = 40 points\n3. Mild pain, no effect on average activities, rarely moderate pain with unusual activity, may take aspirin = 30 points\n4. Moderate pain, tolerable but makes concessions to pain. Some limitation of ordinary activity or work. May require occasional pain medicine stronger than aspirin = 20 points\n5. Marked pain, serious limitation of activities = 10 points\n6. Totally disabled, crippled, pain in bed, bedridden = 0 points', '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 hips analyzed is based upon the preoperative population.'}, {'type': 'SECONDARY', 'title': 'Change in Harris Hip Score (HHS) Range of Motion (ROM) Score From Pre-operative to Post-operative Visits.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}, {'units': 'hip', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LFIT™Femoral Heads With X3® Insert', 'description': 'LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement'}], 'classes': [{'title': 'HHS ROM preoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}, {'units': 'hip', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.05', 'spread': '0.82', 'groupId': 'OG000'}]}]}, {'title': 'HHS ROM 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}, {'units': 'hip', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.00', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'HHS ROM 3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}, {'units': 'hip', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.98', 'spread': '0.14', 'groupId': 'OG000'}]}]}, {'title': 'HHS ROM 5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}, {'units': 'hip', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.00', 'spread': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'To test if the change from pre-operative HHS ROM compared to the post-operative HHS ROM at all intervals is statistically significant.'}], 'paramType': 'MEAN', 'timeFrame': 'preoperative, 1, 3, and 5 Years', 'description': 'This subscore of the overall HHS includes the total points awarded for five different ranges of motion (flexion, abduction, external rotation, internal rotation, adduction). Subscore range is minimum of 0 to maximum of 5 points; the higher the value, the better the outcome.\n\nFlexion:\n\n0-45 degrees x 1.0 index value = max 45 points\n\n45-90 degrees x 0.6 index = max 27 points\n\n90-110 degrees x 0.3 index = max 6 points\n\n110-130 degrees = max 0 points\n\nAbduction:\n\n0-15 degrees x 0.8 index = max 12 points\n\n15-20 degrees x 0.3 index = max 1.5 points\n\n20-45 degrees x 0 index = max 0 points\n\nExternal Rotation in extension:\n\n0-15 degrees x 0.4 index = max 6 points\n\nOver 15 degrees = max 0 points\n\nInternal Rotation in extension:\n\nAny = max 0 points\n\nAdduction:\n\n0-15 degrees x 0.2 index = max 3 points\n\nOver 15 degrees - max 0 points\n\nTo determine the over-all rating for range of motion, multiply the sum of the index values x 0.05.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hip', 'denomUnitsSelected': 'hip', 'populationDescription': 'Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.\n\nCases at 1 and 5 years all had a score of 5, therefore there is zero standard deviation.'}, {'type': 'SECONDARY', 'title': 'Change in SF-12 Health Survey Score (Physical and Mental) From Pre-operative to Post-operative Intervals.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LFIT™Femoral Heads With X3® Insert', 'description': 'LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement'}], 'classes': [{'title': 'SF-12 physical component score preoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34.8', 'spread': '9.47', 'groupId': 'OG000'}]}]}, {'title': 'SF-12 physical component score 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49.93', 'spread': '9.39', 'groupId': 'OG000'}]}]}, {'title': 'SF-12 physical component score 3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.51', 'spread': '7', 'groupId': 'OG000'}]}]}, {'title': 'SF-12 physical component score 5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.35', 'spread': '9.89', 'groupId': 'OG000'}]}]}, {'title': 'SF-12 mental component score preoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.75', 'spread': '12.56', 'groupId': 'OG000'}]}]}, {'title': 'SF-12 mental component score 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.63', 'spread': '7.47', 'groupId': 'OG000'}]}]}, {'title': 'SF-12 mental component score 3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.25', 'spread': '8.91', 'groupId': 'OG000'}]}]}, {'title': 'SF-12 mental component score 5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.92', 'spread': '6.71', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'To test if the change from pre-operative SF-12 Physical component score compared to the post-operative SF-12 Physical component score at all intervals is statistically significant.'}, {'pValue': '0.0394', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'To test if the change from pre-operative SF-12 Mental component score compared to the post-operative SF-12 Mental component score at 1 year is statistically significant.'}, {'pValue': '0.4974', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'To test if the change from pre-operative SF-12 Mental component score compared to the post-operative SF-12 Mental component score at 3 years is statistically significant.'}, {'pValue': '0.6770', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'To test if the change from pre-operative SF-12 Mental component score compared to the post-operative SF-12 Mental component score at 5 years is statistically significant.'}], 'paramType': 'MEAN', 'timeFrame': 'preop, 1, 3, and 5 Years', 'description': 'The change in SF-12 is reported by comparing the mean preoperative, 1, 3, and 5 year scores. The SF-12 Health Survey is a 12 item patient completed questionnaire to measure general health and well-being. It includes a physical component score 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 hips analyzed is based upon the preoperative population.'}, {'type': 'SECONDARY', 'title': 'Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LFIT™Femoral Heads With X3® Insert', 'description': 'LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement'}], 'classes': [{'title': 'LEAS Preoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.41', 'spread': '2.93', 'groupId': 'OG000'}]}]}, {'title': 'LEAS 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.76', 'spread': '3.05', 'groupId': 'OG000'}]}]}, {'title': 'LEAS 3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.56', 'spread': '3.11', 'groupId': 'OG000'}]}]}, {'title': 'LEAS 5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.33', 'spread': '2.69', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'To test if the change from pre-operative LEAS compared to the post-operative LEAS at 1 year and 3 years is statistically significant.'}, {'pValue': '0.0006', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'To test if the change from pre-operative LEAS compared to the post-operative LEAS at 5 years is statistically significant.'}], 'paramType': 'MEAN', 'timeFrame': 'preoperative, 1, 3, and 5 Years', 'description': 'The change in LEAS is reported by comparing the mean pre-operative, 1,3,and 5 year scores. The LEAS 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 hips analyzed is based upon the preoperative population.'}, {'type': 'SECONDARY', 'title': 'Number of Hips That Dislocated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LFIT™Femoral Heads With X3® Insert', 'description': 'LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement'}], 'classes': [{'title': 'Hip dislocations 3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hip dislocations 5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '3 and 5 years', 'description': 'The number of hips that experienced a hip dislocation.', 'unitOfMeasure': 'hips', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hips', 'denomUnitsSelected': 'hips', 'populationDescription': 'Participants/hips with available data. Overall number of participants and hips analyzed is based upon the 3 year population.'}, {'type': 'SECONDARY', 'title': 'Number of Hips Evaluated as Radiographically Unstable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LFIT™Femoral Heads With X3® Insert', 'description': 'LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement'}], 'classes': [{'title': 'Radiographically Unstable Hips 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Radiographically Unstable Hips 3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Radiographically Unstable Hips 5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '1, 3, 5 years', 'description': 'Radiographic instability is defined as having any of the following findings on x-ray:\n\n* Radiographic indication of progressive radiolucent lines ≥ 2 mm in thickness around the entire acetabular component\n* Radiographic indication of migration of ≥ 3 mm or ≥ 5° of the acetabular component\n* Radiographic indication of progressive radiolucent lines ≥ 2 mm thickness around the entire femoral component\n* Radiographic indication of progressive subsidence of the femoral component of ≥ 5 mm.', 'unitOfMeasure': 'hips', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hips', 'denomUnitsSelected': 'hips', 'populationDescription': 'Participants/hips with available data. Overall number of participants and hips analyzed is based upon the 1 year population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Cases That Did Not Have Any Component Revised', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}, {'units': 'hips', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LFIT™Femoral Heads With X3® Insert', 'description': 'LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement'}], 'classes': [{'categories': [{'measurements': [{'value': '97.42', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'A revision is defined as surgical removal and replacement of the femoral bearing head or femoral stem components, or the acetabular shell or acetabular polyethylene liner.\n\nThe 97.42% estimate is obtained by Kaplan-Meier method.', 'unitOfMeasure': 'percentage of hips', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hips', 'denomUnitsSelected': 'hips', 'populationDescription': 'Participants/hips with available data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LFIT™Femoral Heads With X3® Insert', 'description': 'LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '78', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '27', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '51', 'numSubjects': '47'}]}], 'dropWithdraws': [{'type': '5 year not evaluable/missed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Revision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'typeUnitsAnalyzed': 'hips', 'preAssignmentDetails': '89 patients/96 hips - 15 patients/18 hips censored = 74 patients/78 hips'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'LFIT™Femoral Heads With X3® Insert', 'description': 'LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.48', 'spread': '10.37', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'For bilateral total hip replacement participants, the age at time of initial hip replacement surgery is used.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-22', 'studyFirstSubmitDate': '2007-08-01', 'resultsFirstSubmitDate': '2017-12-01', 'studyFirstSubmitQcDate': '2007-08-01', 'lastUpdatePostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-22', 'studyFirstPostDateStruct': {'date': '2007-08-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Linear Wear Rate', 'timeFrame': '5 Years Post-Surgery', 'description': 'Linear wear rate is defined as the annual rate of removal of the polyethylene from the X3 polyethylene insert mated with LFIT™ Anatomic CoCr Femoral Heads determined by comparing digitized images of serial radiographs obtained over the follow-up period.\n\n.'}], 'secondaryOutcomes': [{'measure': 'Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits', 'timeFrame': 'preoperative, 1, 3, and 5 years', 'description': 'The change in HHS is reported by comparing the mean preoperative, 1, 3, and 5 year scores. The 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': 'Change in Harris Hip Score (HHS) Pain Score From Pre-operative to Post-operative Visits', 'timeFrame': 'preop, 1, 3, and 5 Years', 'description': 'This subscore of the overall HHS provides the patient with 6 possible answers to choose from ranging from, no pain/ignores it, to totally disabled/crippled/pain in bed/bedridden. A maximum of 44 points is possible for this subscore indicating no pain/ignores it.\n\nPain:\n\n1. None or ignores it = 44 points\n2. Slight, occasional, no compromise in activities = 40 points\n3. Mild pain, no effect on average activities, rarely moderate pain with unusual activity, may take aspirin = 30 points\n4. Moderate pain, tolerable but makes concessions to pain. Some limitation of ordinary activity or work. May require occasional pain medicine stronger than aspirin = 20 points\n5. Marked pain, serious limitation of activities = 10 points\n6. Totally disabled, crippled, pain in bed, bedridden = 0 points'}, {'measure': 'Change in Harris Hip Score (HHS) Range of Motion (ROM) Score From Pre-operative to Post-operative Visits.', 'timeFrame': 'preoperative, 1, 3, and 5 Years', 'description': 'This subscore of the overall HHS includes the total points awarded for five different ranges of motion (flexion, abduction, external rotation, internal rotation, adduction). Subscore range is minimum of 0 to maximum of 5 points; the higher the value, the better the outcome.\n\nFlexion:\n\n0-45 degrees x 1.0 index value = max 45 points\n\n45-90 degrees x 0.6 index = max 27 points\n\n90-110 degrees x 0.3 index = max 6 points\n\n110-130 degrees = max 0 points\n\nAbduction:\n\n0-15 degrees x 0.8 index = max 12 points\n\n15-20 degrees x 0.3 index = max 1.5 points\n\n20-45 degrees x 0 index = max 0 points\n\nExternal Rotation in extension:\n\n0-15 degrees x 0.4 index = max 6 points\n\nOver 15 degrees = max 0 points\n\nInternal Rotation in extension:\n\nAny = max 0 points\n\nAdduction:\n\n0-15 degrees x 0.2 index = max 3 points\n\nOver 15 degrees - max 0 points\n\nTo determine the over-all rating for range of motion, multiply the sum of the index values x 0.05.'}, {'measure': 'Change in SF-12 Health Survey Score (Physical and Mental) From Pre-operative to Post-operative Intervals.', 'timeFrame': 'preop, 1, 3, and 5 Years', 'description': 'The change in SF-12 is reported by comparing the mean preoperative, 1, 3, and 5 year scores. The SF-12 Health Survey is a 12 item patient completed questionnaire to measure general health and well-being. It includes a physical component score 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) From Pre-operative to Post-operative', 'timeFrame': 'preoperative, 1, 3, and 5 Years', 'description': 'The change in LEAS is reported by comparing the mean pre-operative, 1,3,and 5 year scores. The LEAS 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': 'Number of Hips That Dislocated', 'timeFrame': '3 and 5 years', 'description': 'The number of hips that experienced a hip dislocation.'}, {'measure': 'Number of Hips Evaluated as Radiographically Unstable', 'timeFrame': '1, 3, 5 years', 'description': 'Radiographic instability is defined as having any of the following findings on x-ray:\n\n* Radiographic indication of progressive radiolucent lines ≥ 2 mm in thickness around the entire acetabular component\n* Radiographic indication of migration of ≥ 3 mm or ≥ 5° of the acetabular component\n* Radiographic indication of progressive radiolucent lines ≥ 2 mm thickness around the entire femoral component\n* Radiographic indication of progressive subsidence of the femoral component of ≥ 5 mm.'}, {'measure': 'Percentage of Cases That Did Not Have Any Component Revised', 'timeFrame': '5 years', 'description': 'A revision is defined as surgical removal and replacement of the femoral bearing head or femoral stem components, or the acetabular shell or acetabular polyethylene liner.\n\nThe 97.42% estimate is obtained by Kaplan-Meier method.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arthroplasty, Replacement, Hip']}, 'descriptionModule': {'briefSummary': 'Total hip replacement surgery is considered to be a very successful surgical procedure for the treatment of degenerative joint disease. The purpose of the study is to evaluate a large size (36mm, 40mm or 44mm) femoral (hip) head called the LFIT™ Anatomic CoCr Femoral Head (Low Friction Ion Treatment). The large size femoral heads will be used with the Trident® X3® polyethylene (plastic) inserts and will be compared with a historical control. Study Hypothesis: The linear wear rate for hips implanted with the LFIT™ Anatomic CoCr Femoral Head is no worse than 0.08 mm wear per year at 5 years post-surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient is candidate for a primary cementless total hip replacement, and a posterolateral surgical approach is planned.\n2. Patient's preoperative templating predicts the use of a Hemispherical Acetabular Shell size 52mm or larger.\n3. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). Patient must have diagnosis of osteoarthritis (OA), traumatic arthritis (TA), avascular necrosis (AVN), slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation, or diastrophic variant\n4. Patient is a male or non-pregnant female age 18 years or older at time of enrollment.\n5. Patient has signed an IRB approved, study specific Informed Patient Consent Form.\n6. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.\n\nExclusion Criteria:\n\n1. Patient has an active infection within the affected hip joint.\n2. Patient requires revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.\n3. Patient has a 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 is diagnosed with systemic disease or current life threatening illness and is not able to carry on normal activities of daily life (i.e. Paget's disease, renal osteodystrophy, rheumatoid arthritis).\n6. Patient is immunologically suppressed or receiving chronic steroids in excess of 5mg per day.\n7. Patient has a recent history of substance dependency that may result in deviations from the evaluation schedule.\n8. Patient is a prisoner."}, 'identificationModule': {'nctId': 'NCT00510458', 'acronym': 'LFIT', 'briefTitle': 'LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stryker Orthopaedics'}, 'officialTitle': 'LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study - An Open Label, Prospective, Post-market, Multi-center Clinical Evaluation of the LFIT™ Anatomic CoCr Femoral Heads With X3® Inserts', 'orgStudyIdInfo': {'id': '63'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'LFIT™Femoral Heads With X3® Insert', 'description': 'LFIT™ Femoral Heads With X3® Insert', 'interventionNames': ['Device: LFIT™ Femoral Heads With X3® Insert']}], 'interventions': [{'name': 'LFIT™ Femoral Heads With X3® Insert', 'type': 'DEVICE', 'description': 'LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement', 'armGroupLabels': ['LFIT™Femoral Heads With X3® Insert']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Cedars Medical Center University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '07712', 'city': 'Ocean City', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Seaview Orthopedics', 'geoPoint': {'lat': 39.27762, 'lon': -74.5746}}, {'zip': '97701', 'city': 'Bend', 'state': 'Oregon', 'country': 'United States', 'facility': 'The Center: Orthopedic & Neurosurgical Care & Research', 'geoPoint': {'lat': 44.05817, 'lon': -121.31531}}, {'zip': '15108', 'city': 'Moon Township', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Greater Pittsburgh Orthopaedic Associates', 'geoPoint': {'lat': 40.50896, 'lon': -80.23923}}], 'overallOfficials': [{'name': "James D'Antonio, MD", 'role': 'STUDY_CHAIR', 'affiliation': 'Greater Pittsburgh Orthopaedic Associates'}, {'name': 'Stephen Thomas, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Greater Pittsburgh Orthopaedic Associates'}, {'name': 'Eric Smith, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts University Medical Center'}, {'name': 'Arthur Mark, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seaview Orthopaedic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stryker Orthopaedics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}