Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-25 @ 1:36 PM
Study NCT ID:
NCT01714492
Status:
COMPLETED
Last Update Posted:
2019-10-10
First Post:
2012-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rkomiste@utk.edu', 'phone': '8659744159', 'title': 'Richard Komistek, Ph. D.', 'organization': 'The University of Tennessee'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Small study population; only one specific type of mobile bearing implant was analyzed; no definitive way to quantitatively measure level of wear on various implants to determine if there was any influence on the kinematic performance.'}}, 'adverseEventsModule': {'description': 'There were no adverse effects or events encountered for any subjects for this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly', 'description': 'subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'In Vivo Linear Knee Kinematics From Fluoroscopy Evaluation During Deep Knee Bend Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee', 'description': 'subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.'}], 'classes': [{'title': 'Lateral Anterior Posterior Deep Knee Bend', 'categories': [{'measurements': [{'value': '-4.1', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Medial Anterior Posterior Deep Knee Bend', 'categories': [{'measurements': [{'value': '1.2', 'spread': '2.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 yrs post-operative', 'description': "The values that were reported indicate the motion of the contact point from full extension to patient's maximum flexion. Throughout flexion, if the point translated forward (anteriorly) atop the tibial tray, the number was reported as positive. If the point traveled backwards (posteriorly) atop the tibial tray, the number was reported as negative.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants', 'populationDescription': 'Subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.'}, {'type': 'SECONDARY', 'title': 'In Vivo Knee Force Values From Fluoroscopy Evaluation During Deep Knee Bend Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly', 'description': 'subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.'}], 'classes': [{'title': 'Medial Condyle Knee Force at Maximum Flexion', 'categories': [{'measurements': [{'value': '1.57', 'spread': '0.53', 'groupId': 'OG000'}]}]}, {'title': 'Lateral Condyle Knee Force at Maximum Flexion', 'categories': [{'measurements': [{'value': '1.39', 'spread': '0.36', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 yrs post-operative', 'description': 'The intended unit of measure is "times Body Weight" (or xBW), relating to a ratio.', 'unitOfMeasure': 'times body weight', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants', 'populationDescription': 'Subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation'}, {'type': 'PRIMARY', 'title': 'Femoral Axial Rotation With Respect to the Tibia During Deep Knee Bend Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee', 'description': 'subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '5.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 yrs post-operative', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants'}, {'type': 'PRIMARY', 'title': 'Range of Motion During Flexion of Deep Knee Bend Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee', 'description': 'subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.'}], 'classes': [{'categories': [{'measurements': [{'value': '103', 'spread': '11.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 yrs post-operative', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants'}, {'type': 'SECONDARY', 'title': 'Condyle Contact Area at Maximum Flexion During Deep Knee Bend Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee', 'description': 'subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.'}], 'classes': [{'title': 'Medial', 'categories': [{'measurements': [{'value': '109.16', 'spread': '2.82', 'groupId': 'OG000'}]}]}, {'title': 'Lateral', 'categories': [{'measurements': [{'value': '104.78', 'spread': '21.22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 yrs post-operative', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants'}, {'type': 'SECONDARY', 'title': 'Condyle Contact Stress at Maximum Flexion During Deep Knee Bend Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee', 'description': 'subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.'}], 'classes': [{'title': 'Average Medial Condyle Contact Stress', 'categories': [{'measurements': [{'value': '10.66', 'spread': '1.75', 'groupId': 'OG000'}]}]}, {'title': 'Average Lateral Condyle Contact Stress', 'categories': [{'measurements': [{'value': '10.05', 'spread': '1.45', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 yrs post-operative', 'unitOfMeasure': 'MPa', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly', 'description': 'subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'hospital, medical clinic'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly', 'description': 'subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '74', 'spread': '8.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-08', 'studyFirstSubmitDate': '2012-10-23', 'resultsFirstSubmitDate': '2013-05-23', 'studyFirstSubmitQcDate': '2012-10-25', 'lastUpdatePostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-01-21', 'studyFirstPostDateStruct': {'date': '2012-10-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In Vivo Linear Knee Kinematics From Fluoroscopy Evaluation During Deep Knee Bend Activity', 'timeFrame': '10 yrs post-operative', 'description': "The values that were reported indicate the motion of the contact point from full extension to patient's maximum flexion. Throughout flexion, if the point translated forward (anteriorly) atop the tibial tray, the number was reported as positive. If the point traveled backwards (posteriorly) atop the tibial tray, the number was reported as negative."}, {'measure': 'Femoral Axial Rotation With Respect to the Tibia During Deep Knee Bend Activity', 'timeFrame': '10 yrs post-operative'}, {'measure': 'Range of Motion During Flexion of Deep Knee Bend Activity', 'timeFrame': '10 yrs post-operative'}], 'secondaryOutcomes': [{'measure': 'In Vivo Knee Force Values From Fluoroscopy Evaluation During Deep Knee Bend Activity', 'timeFrame': '10 yrs post-operative', 'description': 'The intended unit of measure is "times Body Weight" (or xBW), relating to a ratio.'}, {'measure': 'Condyle Contact Area at Maximum Flexion During Deep Knee Bend Activity', 'timeFrame': '10 yrs post-operative'}, {'measure': 'Condyle Contact Stress at Maximum Flexion During Deep Knee Bend Activity', 'timeFrame': '10 yrs post-operative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Total Knee Arthroplasty (TKA)', 'in vivo mechanics', 'kinematics', 'fluoroscopy'], 'conditions': ['Knee Prosthesis', 'Knee Replacement Arthroplasty']}, 'descriptionModule': {'briefSummary': 'Utilize previously developed mathematical model to determine in vivo knee mechanics (kinematics, forces, stresses, areas and sound) for subjects having a Sigma Posterior Stabilizing (PS) mobile bearing (MB) total knee arthroplasty (TKA). There are several hypotheses for this study, although the most prominent is: Subjects having a Sigma RP PS TKA will experience polyethylene bearing rotation at 10 years post-operative, similar to their previous evaluations at six months, two years and five years.', 'detailedDescription': 'Additional hypotheses:\n\n* Subjects having a Sigma RP PS TKA will experience full ideal femorotibial contact mechanics.\n* Subjects having a Sigma RP PS TKA will experience optimal cam/post mechanics.\n* Subjects having a Sigma RP PS TKA will experience continuous axial rotation in deep flexion.\n* Subjects having a Sigma RP PS TKA will experience optimal distribution of tibio-femoral and cam/post contact forces over a broad area on the post.\n* Subjects having a Sigma RP PS TKA will experience a smooth transition of the cam on the post, not an abrupt slide as seen with fixed bearing PS TKA.\n* The use of the sound sensors will detect cam/post contact mechanics under in vivo conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients are eight mobile bearing subjects that were implanted over 10 years ago with a custom polyethylene insert that has four beads rigidly inserted into the polyethylene component.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least six months post-operative\n* Between 40-85 years of age\n* Have a body weight of less than 250 lbs.\n* Judged clinically successful with a AKS greater than 90\n* Have the DePuy Sigma mobile bearing TKA\n* Good-to-excellent post-operative passive flexion\n* Must be willing to sign the IC and HIPAA forms.\n\nExclusion Criteria:\n\n* Pregnant females\n* Those not willing to sign the IC and HIPAA forms'}, 'identificationModule': {'nctId': 'NCT01714492', 'acronym': 'Sigma MB TKA', 'briefTitle': 'Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA', 'organization': {'class': 'OTHER', 'fullName': 'The University of Tennessee, Knoxville'}, 'officialTitle': 'In Vivo Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA', 'orgStudyIdInfo': {'id': '11019'}, 'secondaryIdInfos': [{'id': 'R01 1373 424', 'type': 'OTHER', 'domain': 'The University of Tennessee'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly', 'description': 'subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads', 'interventionNames': ['Device: Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly']}], 'interventions': [{'name': 'Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly', 'type': 'DEVICE', 'description': 'Sigma PS RP TKA including a polyethylene insert with 4 beads', 'armGroupLabels': ['Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80210', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Porter Adventist Hospital, Colorado Joint Replacement', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '37996', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Perkins Hall, The University of Tennessee', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '37996', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Science and Engineering Research Facility, The University of Tennessee', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}], 'overallOfficials': [{'name': 'Richard D Komistek, Ph. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Tennessee'}, {'name': 'Dennis A Douglas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Colorado Joint Replacement'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Tennessee, Knoxville', 'class': 'OTHER'}, 'collaborators': [{'name': 'DePuy Orthopaedics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Richard Komistek', 'investigatorAffiliation': 'The University of Tennessee, Knoxville'}}}}