Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-01 @ 8:13 PM
Study NCT ID:
NCT04321356
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2019-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Analysis of Competitive Posterior Cruciate Retaining (PCR) and Posterior Stabilized (PS) Total Knee Arthroplasty (TKA)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mlacour@utk.edu', 'phone': '865-974-9376', 'title': 'Michael LaCour', 'organization': 'University of Tennessee'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events would occur and therefore are collected only during the single day of data collection. Thus, we would know right away, and therefore the specific time period is 1 day. There is no participant follow up after data collection, and participants were not monitored after data collection.', 'eventGroups': [{'id': 'EG000', 'title': 'Stryker Triathlon PCR TKA', 'description': 'Subjects implanted with a Stryker Triathlon PCR TKA\n\nTriathlon PCR TKA: Total Knee Arthroplasty System', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Stryker Triathlon PS TKA', 'description': 'Subjects implanted with a Stryker Triathlon PS TKA\n\nTriathlon PS TKA: Total Knee Arthroplasty System', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Zimmer Persona PCR TKA', 'description': 'Subjects implanted with a Zimmer Persona PCR TKA\n\nPersona PCR TKA: Total Knee Arthroplasty System', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Zimmer Persona PS TKA', 'description': 'Subjects implanted with a Zimmer Persona PS TKA\n\nPersona PS TKA: Total Knee Arthroplasty System', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Medial AP Translations, in mm, During Deep Knee Bend (DKB) Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stryker Triathlon PCR TKA', 'description': 'Subjects implanted with a Stryker Triathlon PCR TKA\n\nTriathlon PCR TKA: Total Knee Arthroplasty System'}, {'id': 'OG001', 'title': 'Stryker Triathlon PS TKA', 'description': 'Subjects implanted with a Stryker Triathlon PS TKA\n\nTriathlon PS TKA: Total Knee Arthroplasty System'}, {'id': 'OG002', 'title': 'Zimmer Persona PCR TKA', 'description': 'Subjects implanted with a Zimmer Persona PCR TKA\n\nPersona PCR TKA: Total Knee Arthroplasty System'}, {'id': 'OG003', 'title': 'Zimmer Persona PS TKA', 'description': 'Subjects implanted with a Zimmer Persona PS TKA\n\nPersona PS TKA: Total Knee Arthroplasty System'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '2.1', 'groupId': 'OG002'}, {'value': '-3.3', 'spread': '4.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months post-operative', 'description': 'Anterior Posterior (AP) translations, in mm, of medial femoral condyle during deep knee bend activity. Positive values indicate anterior motion of the medial femoral condyle, and negative values indicate posterior motion of the medial femoral condyle.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lateral AP Translations, in mm, During Deep Knee Bend (DKB) Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stryker Triathlon PCR TKA', 'description': 'Subjects implanted with a Stryker Triathlon PCR TKA\n\nTriathlon PCR TKA: Total Knee Arthroplasty System'}, {'id': 'OG001', 'title': 'Stryker Triathlon PS TKA', 'description': 'Subjects implanted with a Stryker Triathlon PS TKA\n\nTriathlon PS TKA: Total Knee Arthroplasty System'}, {'id': 'OG002', 'title': 'Zimmer Persona PCR TKA', 'description': 'Subjects implanted with a Zimmer Persona PCR TKA\n\nPersona PCR TKA: Total Knee Arthroplasty System'}, {'id': 'OG003', 'title': 'Zimmer Persona PS TKA', 'description': 'Subjects implanted with a Zimmer Persona PS TKA\n\nPersona PS TKA: Total Knee Arthroplasty System'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '3.5', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '2.3', 'groupId': 'OG002'}, {'value': '-5.2', 'spread': '4.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months post-operative', 'description': 'Anterior Posterior (AP) translations, in mm, of lateral femoral condyle during deep knee bend activity. Positive values indicate anterior motion of the lateral femoral condyle, and negative values indicate posterior motion of the lateral femoral condyle.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Maximum Flexion, in Degrees, During Deep Knee Bend Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stryker Triathlon PCR TKA', 'description': 'Subjects implanted with a Stryker Triathlon PCR TKA\n\nTriathlon PCR TKA: Total Knee Arthroplasty System'}, {'id': 'OG001', 'title': 'Stryker Triathlon PS TKA', 'description': 'Subjects implanted with a Stryker Triathlon PS TKA\n\nTriathlon PS TKA: Total Knee Arthroplasty System'}, {'id': 'OG002', 'title': 'Zimmer Persona PCR TKA', 'description': 'Subjects implanted with a Zimmer Persona PCR TKA\n\nPersona PCR TKA: Total Knee Arthroplasty System'}, {'id': 'OG003', 'title': 'Zimmer Persona PS TKA', 'description': 'Subjects implanted with a Zimmer Persona PS TKA\n\nPersona PS TKA: Total Knee Arthroplasty System'}], 'classes': [{'categories': [{'measurements': [{'value': '107', 'spread': '11', 'groupId': 'OG000'}, {'value': '101', 'spread': '16', 'groupId': 'OG001'}, {'value': '107', 'spread': '11', 'groupId': 'OG002'}, {'value': '114', 'spread': '17', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months post-operative', 'description': 'Maximum weight-bearing flexion, in degrees, during deep knee bend activity', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Axial Rotation, in Degrees, During Deep Knee Bend Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stryker Triathlon PCR TKA', 'description': 'Subjects implanted with a Stryker Triathlon PCR TKA\n\nTriathlon PCR TKA: Total Knee Arthroplasty System'}, {'id': 'OG001', 'title': 'Stryker Triathlon PS TKA', 'description': 'Subjects implanted with a Stryker Triathlon PS TKA\n\nTriathlon PS TKA: Total Knee Arthroplasty System'}, {'id': 'OG002', 'title': 'Zimmer Persona PCR TKA', 'description': 'Subjects implanted with a Zimmer Persona PCR TKA\n\nPersona PCR TKA: Total Knee Arthroplasty System'}, {'id': 'OG003', 'title': 'Zimmer Persona PS TKA', 'description': 'Subjects implanted with a Zimmer Persona PS TKA\n\nPersona PS TKA: Total Knee Arthroplasty System'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '3.7', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '4.0', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '4.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months post-operative', 'description': 'Axial rotation (AR), in degrees, during deep knee bend activity. Positive values indicate external femorotibial axial rotation, and negative values indicate internal femorotibial axial rotation.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stryker Triathlon PCR TKA', 'description': 'Subjects implanted with a Stryker Triathlon PCR TKA\n\nTriathlon PCR TKA: Total Knee Arthroplasty System'}, {'id': 'FG001', 'title': 'Stryker Triathlon PS TKA', 'description': 'Subjects implanted with a Stryker Triathlon PS TKA\n\nTriathlon PS TKA: Total Knee Arthroplasty System'}, {'id': 'FG002', 'title': 'Zimmer Persona PCR TKA', 'description': 'Subjects implanted with a Zimmer Persona PCR TKA\n\nPersona PCR TKA: Total Knee Arthroplasty System'}, {'id': 'FG003', 'title': 'Zimmer Persona PS TKA', 'description': 'Subjects implanted with a Zimmer Persona PS TKA\n\nPersona PS TKA: Total Knee Arthroplasty System'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Stryker Triathlon PCR TKA', 'description': 'Subjects implanted with a Stryker Triathlon PCR TKA\n\nTriathlon PCR TKA: Total Knee Arthroplasty System'}, {'id': 'BG001', 'title': 'Stryker Triathlon PS TKA', 'description': 'Subjects implanted with a Stryker Triathlon PS TKA\n\nTriathlon PS TKA: Total Knee Arthroplasty System'}, {'id': 'BG002', 'title': 'Zimmer Persona PCR TKA', 'description': 'Subjects implanted with a Zimmer Persona PCR TKA\n\nPersona PCR TKA: Total Knee Arthroplasty System'}, {'id': 'BG003', 'title': 'Zimmer Persona PS TKA', 'description': 'Subjects implanted with a Zimmer Persona PS TKA\n\nPersona PS TKA: Total Knee Arthroplasty System'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], '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': '31', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-16', 'size': 261835, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-05-16T14:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-16', 'studyFirstSubmitDate': '2019-12-19', 'resultsFirstSubmitDate': '2022-05-16', 'studyFirstSubmitQcDate': '2020-03-23', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-16', 'studyFirstPostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medial AP Translations, in mm, During Deep Knee Bend (DKB) Activity', 'timeFrame': '3 months post-operative', 'description': 'Anterior Posterior (AP) translations, in mm, of medial femoral condyle during deep knee bend activity. Positive values indicate anterior motion of the medial femoral condyle, and negative values indicate posterior motion of the medial femoral condyle.'}, {'measure': 'Lateral AP Translations, in mm, During Deep Knee Bend (DKB) Activity', 'timeFrame': '3 months post-operative', 'description': 'Anterior Posterior (AP) translations, in mm, of lateral femoral condyle during deep knee bend activity. Positive values indicate anterior motion of the lateral femoral condyle, and negative values indicate posterior motion of the lateral femoral condyle.'}, {'measure': 'Maximum Flexion, in Degrees, During Deep Knee Bend Activity', 'timeFrame': '3 months post-operative', 'description': 'Maximum weight-bearing flexion, in degrees, during deep knee bend activity'}, {'measure': 'Axial Rotation, in Degrees, During Deep Knee Bend Activity', 'timeFrame': '3 months post-operative', 'description': 'Axial rotation (AR), in degrees, during deep knee bend activity. Positive values indicate external femorotibial axial rotation, and negative values indicate internal femorotibial axial rotation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Total Knee Arthroplasty'], 'conditions': ['Knee Osteoarthritis', 'Total Knee Arthroplasty', 'Knee']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to acquire kinematic in vivo fluoroscopy data from subjects who were implanted with Stryker Posterior Cruciate Retaining (PCR) , Stryker Posterior Stabilized (PS), Zimmer PCR, and Zimmer PS Total Knee Arthroplasty (TKAs). Our lab has previously collected data for the Smith \\& Nephew PCR, bi-cruciate retaining (BCR), and bi-cruciate stabilized (BCS) TKA.', 'detailedDescription': 'The objective for this study is to analyze the in vivo kinematics for subjects implanted with either a Stryker PCR, Stryker PS, Zimmer PCR, and Zimmer PS TKA and to compare those patterns to subjects having a normal knee from our previous study and to those patterns from subjects having a Smith \\& Nephew PCR, BCR, and BCS TKA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients implanted with a Stryker Triathlon PCR, Stryker Triathlon PS, Zimmer Persona PCR, or Zimmer Persona PS total knee arthroplasty (TKA) implanted by Dr. Harold E. Cates.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects will have one of the following implant types: 1) Stryker Triathlon PCR TKA (28 subjects), 2) Stryker Triathlon PS TKA (28 subjects), 3) Zimmer Persona PCR TKA (28 subjects) and 4) Zimmer Persona PS TKA (28 subjects).\n2. Patients must be at least three months post-operative.\n3. Participants must not experience any pain or other post-operative complications.\n4. Participants must have a stable TKA and be capable of performing a deep knee bend activity.\n5. Participants must weigh less than 300 lbs., not underweight (BMI \\< 18.5) or too obese (BMI\\>35).\n6. Must be in the age range of 18 years to 85 years (both inclusive).\n7. Participants must be able to perform the required activities without concern.\n8. Subjects must be willing to sign the Informed Consent (IC) form to participate in the study.\n9. Patients who do not have previous surgery on the implanted knee that might restrict their movement.\n\nExclusion Criteria:\n\n1. Pregnant, potentially pregnant, lactating females or of childbearing age. 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. (All potential female study patients will be asked if they are premenopausal or if they have undergone a hysterectomy. If the possibility of pregnancy exists, a pregnancy kit will be given to the patient at the informed consent meeting, just prior to the fluoro. Results of the test will be recorded in a test log. Any female patient showing a positive test will be excluded from testing.)\n2. Subjects without the required type of knee implant.\n3. Cannot have pain in other parts of the body that would prohibit the subject from performing the activities).\n4. Cannot have ligamentous pain and/or laxity.\n5. Unwilling to sign IC/HIPAA form(s).\n6. Does not speak English.\n7. Patients who have enrolled in a fluoroscopic kinematic study within the past year.\n8. Patients currently involved in any personal injury litigation, medical/legal or worker's compensation claims.\n9. Patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study.\n10. Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability."}, 'identificationModule': {'nctId': 'NCT04321356', 'briefTitle': 'Analysis of Competitive Posterior Cruciate Retaining (PCR) and Posterior Stabilized (PS) Total Knee Arthroplasty (TKA)', 'organization': {'class': 'OTHER', 'fullName': 'The University of Tennessee, Knoxville'}, 'officialTitle': 'Analysis of Competitive PCR and PS Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '3187FB WIRB20180745 Extension'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stryker Triathlon PCR TKA', 'description': 'Subjects implanted with a Stryker Triathlon PCR TKA', 'interventionNames': ['Device: Triathlon PCR TKA']}, {'label': 'Stryker Triathlon PS TKA', 'description': 'Subjects implanted with a Stryker Triathlon PS TKA', 'interventionNames': ['Device: Triathlon PS TKA']}, {'label': 'Zimmer Persona PCR TKA', 'description': 'Subjects implanted with a Zimmer Persona PCR TKA', 'interventionNames': ['Device: Persona PCR TKA']}, {'label': 'Zimmer Persona PS TKA', 'description': 'Subjects implanted with a Zimmer Persona PS TKA', 'interventionNames': ['Device: Persona PS TKA']}], 'interventions': [{'name': 'Triathlon PCR TKA', 'type': 'DEVICE', 'description': 'Total Knee Arthroplasty System', 'armGroupLabels': ['Stryker Triathlon PCR TKA']}, {'name': 'Triathlon PS TKA', 'type': 'DEVICE', 'description': 'Total Knee Arthroplasty System', 'armGroupLabels': ['Stryker Triathlon PS TKA']}, {'name': 'Persona PCR TKA', 'type': 'DEVICE', 'description': 'Total Knee Arthroplasty System', 'armGroupLabels': ['Zimmer Persona PCR TKA']}, {'name': 'Persona PS TKA', 'type': 'DEVICE', 'description': 'Total Knee Arthroplasty System', 'armGroupLabels': ['Zimmer Persona PS TKA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37923', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Orthopaedic Clinic', '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, PhD', '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': 'Smith & Nephew, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Richard Komistek', 'investigatorAffiliation': 'The University of Tennessee, Knoxville'}}}}