Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-02-25 @ 6:59 PM
Study NCT ID:
NCT02682602
Status:
COMPLETED
Last Update Posted:
2019-11-25
First Post:
2015-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
THA Kinematics and Sound for Subjects for Normal, Diseased and Implanted Hips
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D025981', 'term': 'Hip Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rkomiste@utk.edu', 'phone': '8659742093', 'title': 'Richard Komistek, Principal Investigator', 'organization': 'University of Tennessee'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'approximately 2 years, 8 months', 'eventGroups': [{'id': 'EG000', 'title': 'Diseased Hip', 'description': 'Subjects will have a diseased hip which requires replacement, which will be implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Normal Hip', 'description': 'Subjects will have a normal hip.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Implanted Group', 'description': 'Diseased hip subjects who were implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Magnitude of Hip Separation During Primary Heel Strike', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diseased Hip (Baseline)', 'description': 'Subjects with a diseased hip which requires replacement, which will be implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.'}, {'id': 'OG001', 'title': 'Normal Hip', 'description': 'Subjects with a normal hip.'}, {'id': 'OG002', 'title': 'Implanted Hip', 'description': 'Subjects from diseased hip group who were implanted with DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.591', 'spread': '1.582', 'groupId': 'OG000'}, {'value': '0.096', 'spread': '1.369', 'groupId': 'OG001'}, {'value': '0.558', 'spread': '0.326', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 2 years postoperatively.', 'description': 'Negative values indicate hip compression, position values indicate hip separation. All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.'}, {'type': 'PRIMARY', 'title': 'Magnitude of Hip Separation During Contra-lateral Toe Off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diseased Hip (Baseline)', 'description': 'Subjects with a diseased hip which requires replacement, which will be implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.'}, {'id': 'OG001', 'title': 'Normal Hip', 'description': 'Subjects with a normal hip.'}, {'id': 'OG002', 'title': 'Implanted Hip', 'description': 'Diseased hip subjects who were implanted with DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.051', 'spread': '1.235', 'groupId': 'OG000'}, {'value': '-0.065', 'spread': '0.986', 'groupId': 'OG001'}, {'value': '1.593', 'spread': '0.307', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 2 years postoperatively.', 'description': 'Negative values indicate hip compression, position values indicate hip separation. All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.'}, {'type': 'PRIMARY', 'title': 'Magnitude of Hip Separation During Contra-lateral Heel Strike', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diseased Hip (Baseline)', 'description': 'Subjects with a diseased hip which requires replacement, which will be implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.'}, {'id': 'OG001', 'title': 'Normal Hip', 'description': 'Subjects with a normal hip.'}, {'id': 'OG002', 'title': 'Implanted Hip', 'description': 'Diseased subjects who were implanted with DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.019', 'spread': '1.808', 'groupId': 'OG000'}, {'value': '-0.344', 'spread': '1.518', 'groupId': 'OG001'}, {'value': '0.566', 'spread': '0.188', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 2 years postoperatively.', 'description': 'Negative values indicate hip compression, position values indicate hip separation. All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.'}, {'type': 'PRIMARY', 'title': 'Magnitude of Hip Separation During Primary Toe Off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diseased Hip (Baseline)', 'description': 'Subjects with a diseased hip which requires replacement, which will be implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.'}, {'id': 'OG001', 'title': 'Normal Hip', 'description': 'Subjects with a normal hip.'}, {'id': 'OG002', 'title': 'Implanted Hip', 'description': 'Diseased subjects who were implanted with DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.936', 'spread': '1.243', 'groupId': 'OG000'}, {'value': '-0.143', 'spread': '1.305', 'groupId': 'OG001'}, {'value': '0.512', 'spread': '0.149', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 2 years postoperatively.', 'description': 'Negative values indicate hip compression, position values indicate hip separation. All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diseased/Implanted Hip', 'description': 'Subjects with a diseased hip which requires replacement, which will be implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.'}, {'id': 'FG001', 'title': 'Normal Hip', 'description': 'Subjects with a normal hip.'}], 'periods': [{'title': 'Pre-operative Diseased & Normal Hips', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Unusable images', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Post-operative Fluoroscopy for Implanted', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'comment': 'Nonimplanted subjects were not analyzed again for the second period, because this would be redundant', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Diseased/Implanted Hip', 'description': 'Subjects with a diseased hip which requires replacement, which will be implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.'}, {'id': 'BG001', 'title': 'Normal Hip', 'description': 'Subjects with a normal hip.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': "One diseased hip subject's pre-operative data images collected from fluoroscopy were unusable and this subject did not participate in post-operative data collection, but participation in pre-operative fluoroscopy counts toward study enrollment. An additional subject was enrolled to attempt to acquire the ten data sets in the protocol."}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': "One subject's pre-operative fluoroscopy images were unusable and this subject did not participate in post-operative data collection. Participation in pre-operative fluoroscopy counts toward total study enrollment."}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': "One subject's pre-operative fluoroscopy images were unusable and this subject did not participate in post-operative data collection. This subject's participation in pre-operative data collection counts toward study enrollment."}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-09', 'size': 1502132, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-10-23T12:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-13', 'studyFirstSubmitDate': '2015-11-20', 'resultsFirstSubmitDate': '2019-09-23', 'studyFirstSubmitQcDate': '2016-02-12', 'lastUpdatePostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-23', 'studyFirstPostDateStruct': {'date': '2016-02-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Magnitude of Hip Separation During Primary Heel Strike', 'timeFrame': 'Approximately 2 years postoperatively.', 'description': 'Negative values indicate hip compression, position values indicate hip separation. All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.'}, {'measure': 'Magnitude of Hip Separation During Contra-lateral Toe Off', 'timeFrame': 'Approximately 2 years postoperatively.', 'description': 'Negative values indicate hip compression, position values indicate hip separation. All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.'}, {'measure': 'Magnitude of Hip Separation During Contra-lateral Heel Strike', 'timeFrame': 'Approximately 2 years postoperatively.', 'description': 'Negative values indicate hip compression, position values indicate hip separation. All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.'}, {'measure': 'Magnitude of Hip Separation During Primary Toe Off', 'timeFrame': 'Approximately 2 years postoperatively.', 'description': 'Negative values indicate hip compression, position values indicate hip separation. All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['total hip arthroplasty'], 'conditions': ['Hip Injuries']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to analyze subjects having a normal hip and compare the in vivo kinematics to subjects requiring a total hip arthroplasty (THA) due to having a diseased hip and then later post-operative to their implanted hip. Ten subjects will have a normal hip, ten hips will be diseased, requiring a THA and then those ten diseased hips will be re-analyzed at least six months post-operatively after implantation of a THA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with a diseased hip that requires THA. OR Subjects with a normal hip.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria for diseased/implanted subjects:\n\n* Subjects will require a THA and will be implanted with either Summit/Pinnacle THA or Corail/Pinnacle THA.\n* Patients must be at least six months post-operative with no other surgical procedures conducted within the past six months that will prohibit them from performing the study activities.\n* Patients must be between 40-85 years of age.\n* Potential subjects will have a body weight of less than 250 lbs.\n* Participants must have Body Mass Index (BMI) of less than 38.\n* Potential subjects' THAs should be judged clinically successful with a HHS \\>90.\n* Subjects must have demonstrated no evidence of post-operative hip subluxation or dislocation.\n* Subjects must not walk with a detectable limp and must be able to actively abduct their operated hip against gravity without difficulty.\n* Participants must be able to walk on level ground, ascend and descend a ramp and rise from a chair without assistance.\n* Patients from the physician's list who do not meet the study requirements will not be considered.\n* Patients must be willing to sign the Informed Consent (IC)/HIPAA form to participate in the study.\n\nExclusion Criteria for diseased/implanted subjects:\n\n* Pregnant, potentially pregnant or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.\n* Subjects without one of the two types of required hip implants.\n* Subjects who have had surgery within the past 6 months that would prohibit them from performing level walking, ascend and descend a ramp and rise from a chair without aid or support of any kind.\n* Subjects who are unable to perform level walking, ascend and descend a ramp and rise from a chair without aid or support.\n* Subjects with pain, functional deficits, or generalized inflammatory.\n* Subjects who walk with a detectable limp.\n* Subjects who cannot actively abduct their operated hip against gravity without difficulty.\n* Subjects who are unwilling to sign IC/HIPAA document.\n* Subjects who have a HHS \\<90.\n\nInclusion Criteria for normal subjects:\n\n* Patients must not have any kind of hip implant.\n* Subjects must not have had any type of hip surgery or any pathological hip conditions, including osteoarthritis, or hip pain.\n* Patients must be between the ages of 18 and 65.\n* Potential subjects will have a body weight of less than 250 lbs.\n* Participants must have BMI of less than 38.\n* Pregnant or potentially pregnant females will be excluded from the study. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.\n* Participants must be able to walk on level ground, ascend and descend a ramp and rise from a chair without aid of any kind or have had any kind of surgical procedure within the past 6 months that would affect his/her ability to perform the study activities.\n* Patients must be willing to sign the IC and HIPAA forms to participate in the study.\n* Patients must be between 160cm (5'3) and 193cm (6'4) tall\n\nExclusion Criteria for normal subjects:\n\n* Pregnant, potentially pregnant or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study\n* Subjects with any kind of hip implant.\n* Subjects who have had any past hip surgery, have pathological hip conditions and/or hip pain.\n* Subjects who have had surgery within the past 6 months that would prohibit them from performing level walking, ascend and descend a ramp and rise from a chair without aid or support of any kind.\n* Subjects who are unable to perform level walking, ascend and descend a ramp and rise from a chair without aid or support.\n* Subjects who are unwilling to sign IC/HIPAA document."}, 'identificationModule': {'nctId': 'NCT02682602', 'briefTitle': 'THA Kinematics and Sound for Subjects for Normal, Diseased and Implanted Hips', 'organization': {'class': 'OTHER', 'fullName': 'The University of Tennessee, Knoxville'}, 'officialTitle': 'In Vivo Determination of Total Hip Arthroplasty (THA) Kinematics and Sound for Subjects for Normal, Diseased and Implanted Hips', 'orgStudyIdInfo': {'id': '2631FB'}, 'secondaryIdInfos': [{'id': 'IIS-14002', 'type': 'OTHER_GRANT', 'domain': 'DePuy Synthes'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diseased Hip', 'description': 'Subjects will have a diseased hip which requires replacement, which will be implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.', 'interventionNames': ['Radiation: Computer tomography', 'Radiation: Fluoroscopy surveillance']}, {'label': 'Normal Hip', 'description': 'Subjects will have a normal hip.', 'interventionNames': ['Radiation: Computer tomography', 'Radiation: Fluoroscopy surveillance']}, {'label': 'Implanted Group', 'description': 'All subjects from the Diseased Hip group were implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA', 'interventionNames': ['Device: DePuy Synthes total hip arthroplasty', 'Radiation: Fluoroscopy surveillance']}], 'interventions': [{'name': 'DePuy Synthes total hip arthroplasty', 'type': 'DEVICE', 'otherNames': ['DePuy Synthes Summit/Pinnacle THA', 'DePuy Synthes Corail/Pinnacle THA'], 'armGroupLabels': ['Implanted Group']}, {'name': 'Computer tomography', 'type': 'RADIATION', 'description': 'Computer tomography (CT) scan of the hip for creation of bone models.', 'armGroupLabels': ['Diseased Hip', 'Normal Hip']}, {'name': 'Fluoroscopy surveillance', 'type': 'RADIATION', 'description': 'Fluoroscopy evaluation of the hip during gait (level walking), chair rise, and ramp ascent and descent activities. Sound/vibration data will be collected simultaneously via non-invasive sensors attached to the hip joint.', 'armGroupLabels': ['Diseased Hip', 'Implanted Group', 'Normal Hip']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30041', 'city': 'Cumming', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northside Hospital- Forsyth , GA 30041', 'geoPoint': {'lat': 34.20732, 'lon': -84.14019}}, {'zip': '37909', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Abercrombie Radiology', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '37996', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The University of Tennessee', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}], 'overallOfficials': [{'name': 'Richard Komistek, Ph. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Tennessee'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Researchers would like to retain this study data in our secure database so as to continue to add relevant, current data to our digital collection to help us work with manufacturers in the future to create better implants that last longer and will not require revision surgery. Participants will be asked if their study data may remain a part of the University of Tennessee's Center for Musculoskeletal Research data collection for use in future studies in the IC. Identifiers are automatically removed from the database upon entry into the secure server. Data shared with sponsors is de-identified."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Tennessee, Knoxville', 'class': 'OTHER'}, 'collaborators': [{'name': 'DePuy Synthes', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fred M. Roddy Professor of Biomedical Engineering', 'investigatorFullName': 'Richard Komistek', 'investigatorAffiliation': 'The University of Tennessee, Knoxville'}}}}