Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-03-04 @ 7:33 AM
Study NCT ID:
NCT01864434
Status:
COMPLETED
Last Update Posted:
2019-10-10
First Post:
2013-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
In Vivo Kinematics Comparison of Stryker or Zimmer Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}], 'ancestors': [{'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'asharma1@utk.edu', 'phone': '8659742093', 'title': 'Adrija Sharma, Ph. D.', 'organization': 'University of Tennessee'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Patients With a Stryker Triathlon CR TKA', 'description': 'Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.\n\nStryker PCR TKA', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Patients With a Zimmer PCR TKA', 'description': 'Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.\n\nZimmer PCR TKA', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Kinematics - Deep Knee Bend Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With a Stryker Triathlon CR TKA', 'description': 'Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.\n\nStryker PCR TKA'}, {'id': 'OG001', 'title': 'Patients With a Zimmer PCR TKA', 'description': 'Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.\n\nZimmer PCR TKA'}], 'classes': [{'title': 'Lateral Anterior Posterior Deep Knee Bend', 'categories': [{'measurements': [{'value': '-0.43', 'spread': '3.43', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '3.23', 'groupId': 'OG001'}]}]}, {'title': 'Medial Anterior Posterior Deep Knee Bend', 'categories': [{'measurements': [{'value': '3.51', 'spread': '2.68', 'groupId': 'OG000'}, {'value': '-0.42', 'spread': '2.20', 'groupId': 'OG001'}]}]}, {'title': 'Axial Rotation Deep Knee Bend', 'categories': [{'measurements': [{'value': '5.20', 'spread': '3.93', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '5.12', 'groupId': 'OG001'}]}]}, {'title': 'Maximum Flexion Deep knee bend', 'categories': [{'measurements': [{'value': '107.80', 'spread': '8.50', 'groupId': 'OG000'}, {'value': '107.20', 'spread': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months post-operative', 'description': 'Lateral Anterior Posterior (LAP) and Medial Anterior Posterior (MAP) translations, and Axial Rotation (AR) and maximum flexion of medial femoral condyles during deep knee bend (DKB) activity', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Kinematics - Ramp up Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With a Stryker Triathlon CR TKA', 'description': 'Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.\n\nStryker PCR TKA'}, {'id': 'OG001', 'title': 'Patients With a Zimmer PCR TKA', 'description': 'Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.\n\nZimmer PCR TKA'}], 'classes': [{'title': 'Lateral Anterior Posterior Translation 0% to 33%', 'categories': [{'measurements': [{'value': '-0.31', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '2.75', 'groupId': 'OG001'}]}]}, {'title': 'Lateral Anterior Posterior Translation 33% to 66%', 'categories': [{'measurements': [{'value': '-0.94', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '-0.61', 'spread': '2.42', 'groupId': 'OG001'}]}]}, {'title': 'Lateral Anterior Posterior Translation 66% to 100%', 'categories': [{'measurements': [{'value': '-0.23', 'spread': '2.69', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '2.70', 'groupId': 'OG001'}]}]}, {'title': 'Medial Anterior Posterior Translation 0% to 33%', 'categories': [{'measurements': [{'value': '-1.31', 'spread': '3.43', 'groupId': 'OG000'}, {'value': '-1.88', 'spread': '2.07', 'groupId': 'OG001'}]}]}, {'title': 'Medial Anterior Posterior Translation 33% to 66%', 'categories': [{'measurements': [{'value': '-1.04', 'spread': '3.36', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '2.16', 'groupId': 'OG001'}]}]}, {'title': 'Medial Anterior Posterior Translation 66% to 100%', 'categories': [{'measurements': [{'value': '0.48', 'spread': '2.35', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '1.63', 'groupId': 'OG001'}]}]}, {'title': 'Axial Rotation 0% to 33%', 'categories': [{'measurements': [{'value': '-1.33', 'spread': '4.03', 'groupId': 'OG000'}, {'value': '-2.69', 'spread': '3.99', 'groupId': 'OG001'}]}]}, {'title': 'Axial Rotation 33% to 66%', 'categories': [{'measurements': [{'value': '-0.15', 'spread': '3.17', 'groupId': 'OG000'}, {'value': '1.27', 'spread': '3.42', 'groupId': 'OG001'}]}]}, {'title': 'Axial Rotation 66% to 100%', 'categories': [{'measurements': [{'value': '0.95', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '3.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months post-operative', 'description': 'Lateral Anterior Posterior (LAP) \\[during 3 moments - 0-33%, 33-66% and 66-100%\\] and Medial Anterior Posterior (MAP) \\[during 3 moments - 0-33%, 33-66% and 66-100%\\] translations, and Axial Rotation (AR) \\[during 3 moments - 0-33%, 33-66% and 66-100%\\] of medial femoral condyles during ramp up activity', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Kinematics - Ramp Down Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With a Stryker Triathlon CR TKA', 'description': 'Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.\n\nStryker PCR TKA'}, {'id': 'OG001', 'title': 'Patients With a Zimmer PCR TKA', 'description': 'Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.\n\nZimmer PCR TKA'}], 'classes': [{'title': 'Lateral Anterior Posterior Translation 0% to 33%', 'categories': [{'measurements': [{'value': '-0.57', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '-1.11', 'spread': '2.27', 'groupId': 'OG001'}]}]}, {'title': 'Lateral Anterior Posterior Translation 33% to 66%', 'categories': [{'measurements': [{'value': '-1.25', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '-0.96', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Lateral Anterior Posterior Translation 66% to 100%', 'categories': [{'measurements': [{'value': '0.83', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '2.37', 'groupId': 'OG001'}]}]}, {'title': 'Medial Anterior Posterior Translation 0% to 33%', 'categories': [{'measurements': [{'value': '-0.87', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '-0.92', 'spread': '1.95', 'groupId': 'OG001'}]}]}, {'title': 'Medial Anterior Posterior Translation 33% to 66%', 'categories': [{'measurements': [{'value': '-.75', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '0', 'spread': '1.27', 'groupId': 'OG001'}]}]}, {'title': 'Medial Anterior Posterior Translation 66% to 100%', 'categories': [{'measurements': [{'value': '1.29', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '1.44', 'groupId': 'OG001'}]}]}, {'title': 'Axial Rotation 0% to 33%', 'categories': [{'measurements': [{'value': '-0.44', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '3.19', 'groupId': 'OG001'}]}]}, {'title': 'Axial Rotation 33% to 66%', 'categories': [{'measurements': [{'value': '0.67', 'spread': '3.09', 'groupId': 'OG000'}, {'value': '1.22', 'spread': '3.97', 'groupId': 'OG001'}]}]}, {'title': 'Axial Rotation 66% to 100%', 'categories': [{'measurements': [{'value': '0.59', 'spread': '3.39', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '3.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months post-operative', 'description': 'Lateral Anterior Posterior (LAP) \\[during 3 moments - 0-33%, 33-66% and 66-100%\\] and Medial Anterior Posterior (MAP) \\[during 3 moments - 0-33%, 33-66% and 66-100%\\] translations, and Axial Rotation (AR) \\[during 3 moments - 0-33%, 33-66% and 66-100%\\] of medial femoral condyles during ramp down activity', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients With a Stryker Triathlon CR TKA', 'description': 'Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.\n\nStryker PCR TKA'}, {'id': 'FG001', 'title': 'Patients With a Zimmer PCR TKA', 'description': 'Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.\n\nZimmer PCR TKA'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients With a Stryker Triathlon CR TKA', 'description': 'Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.\n\nStryker PCR TKA'}, {'id': 'BG001', 'title': 'Patients With a Zimmer PCR TKA', 'description': 'Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.\n\nZimmer PCR TKA'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'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': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.7', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '70.6', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '69.60', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-08', 'studyFirstSubmitDate': '2013-05-16', 'resultsFirstSubmitDate': '2014-12-15', 'studyFirstSubmitQcDate': '2013-05-23', 'lastUpdatePostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-12-15', 'studyFirstPostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kinematics - Deep Knee Bend Activity', 'timeFrame': '3 months post-operative', 'description': 'Lateral Anterior Posterior (LAP) and Medial Anterior Posterior (MAP) translations, and Axial Rotation (AR) and maximum flexion of medial femoral condyles during deep knee bend (DKB) activity'}, {'measure': 'Kinematics - Ramp up Activity', 'timeFrame': '3 months post-operative', 'description': 'Lateral Anterior Posterior (LAP) \\[during 3 moments - 0-33%, 33-66% and 66-100%\\] and Medial Anterior Posterior (MAP) \\[during 3 moments - 0-33%, 33-66% and 66-100%\\] translations, and Axial Rotation (AR) \\[during 3 moments - 0-33%, 33-66% and 66-100%\\] of medial femoral condyles during ramp up activity'}, {'measure': 'Kinematics - Ramp Down Activity', 'timeFrame': '3 months post-operative', 'description': 'Lateral Anterior Posterior (LAP) \\[during 3 moments - 0-33%, 33-66% and 66-100%\\] and Medial Anterior Posterior (MAP) \\[during 3 moments - 0-33%, 33-66% and 66-100%\\] translations, and Axial Rotation (AR) \\[during 3 moments - 0-33%, 33-66% and 66-100%\\] of medial femoral condyles during ramp down activity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Knee Prosthesis', 'Total Knee Arthroplasty', 'Cruciate Retaining', 'Posterior Cruciate Retaining'], 'conditions': ['Knee Prosthesis']}, 'descriptionModule': {'briefSummary': 'This study will compare the kinematics data collected from patients with implants created by different manufacturers to see which of these implants provides a more normal-like kinematic pattern compared to the normal knee.', 'detailedDescription': "A better understanding of knee joint kinematics is important to explain premature polyethylene wear failures within knee implants and to help design a prosthesis that most closely approximates the normal knee. Therefore, the objectives for this study are to compare the in vivo kinematic patterns for subjects implanted with either a Stryker Triathlon Posterior Cruciate Retaining (PCR) Total Knee Arthroplasty (TKA) or Zimmer NexGen PCR TKA design to determine if there are any kinematic differences between these TKA designs. Each subject will be asked to undergo a fluoroscopic evaluation while performing weight-bearing activities under surveillance using the University of Tennessee's new mobile tracking fluoroscopic unit while performing deep knee bend and ramp up and ramp down activities. The mobile fluoroscopy unit is approved for use by the State of Tennessee on a study-by-study basis after IRB approval is obtained for each study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be patients of Dr. Harold E. Cates of Tennessee Orthopaedic Clinics and must have been implanted with either a Stryker Triathlon CR TKA or Zimmer PCR TKA', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must be at least 3 months post-operative with no other surgical procedures conducted within the past 6 months\n* Must have body weight of less than 250 lbs\n* Must have Body Mass Index of less than 38\n* Must be judged clinically successful with a Knee Society Score \\>90\n* Must have 100% post-operative passive flexion with no ligamentous laxity or pain\n* Must be able to walk on level ground without aid of any kind\n* Must be able to ascend and descend a ramp with a 10 degree incline with no assistance\n* Must be willing to sign both Informed Consent and HIPAA forms\n* Must be between 160 cm (5'3) and 193 cm (6'4) tall\n\nExclusion Criteria:\n\n* Pregnant or potentially pregnant females\n* Unwilling to sign Informed Consent or HIPAA forms"}, 'identificationModule': {'nctId': 'NCT01864434', 'briefTitle': 'In Vivo Kinematics Comparison of Stryker or Zimmer Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'The University of Tennessee, Knoxville'}, 'officialTitle': 'In Vivo Comparison of Kinematics for Patients Implanted With Either a Stryker or a Zimmer Posterior Cruciate Retaining Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '130180/2012017'}, 'secondaryIdInfos': [{'id': 'R011373454', 'type': 'OTHER_GRANT', 'domain': 'Stryker Orthopaedic'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with a Stryker Triathlon CR TKA', 'description': 'Patients implanted with a Stryker Triathlon Posterior Cruciate Retaining Total Knee Arthroplasty.', 'interventionNames': ['Device: Stryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA)']}, {'label': 'Patients with a Zimmer PCR TKA', 'description': 'Patients implanted with a Zimmer NexGen Posterior Cruciate Retaining Total Knee Arthroplasty.', 'interventionNames': ['Device: Zimmer PCR TKA']}], 'interventions': [{'name': 'Stryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA)', 'type': 'DEVICE', 'otherNames': ['Triathlon PCR TKA'], 'description': 'The fluoroscopy procedure itself is used as a means of data collection and is not the intervention under investigation; therefore, the study is observational and not interventional.', 'armGroupLabels': ['Patients with a Stryker Triathlon CR TKA']}, {'name': 'Zimmer PCR TKA', 'type': 'DEVICE', 'otherNames': ['Zimmer NexGen PCR TKA'], 'description': 'The fluoroscopy procedure itself is used as a means of data collection and is not the intervention under investigation; therefore, the study is observational and not interventional.', 'armGroupLabels': ['Patients with a Zimmer PCR TKA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37923', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Orthopaedic Clinic, Tennessee Orthopaedic Foundation for Education & Research', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '37996', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Dougherty Engineering Building, Room M007', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'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', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}], 'overallOfficials': [{'name': 'Adrija Sharma, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Tennessee'}, {'name': 'Richard D Komistek, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Tennessee'}, {'name': 'William R Hamel, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Tennessee'}, {'name': 'Harold E Cates, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tennessee Orthopaedic Clinics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Tennessee, Knoxville', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stryker Orthopaedics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Richard Komistek', 'investigatorAffiliation': 'The University of Tennessee, Knoxville'}}}}