Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-29 @ 9:32 AM
Study NCT ID:
NCT01301950
Status:
COMPLETED
Last Update Posted:
2019-04-10
First Post:
2010-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty
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': 'shimden@its.jnj.com', 'phone': '574-372-7231', 'title': 'Sam Himden, Clinical Portfolio Leader', 'organization': 'DePuy Synthes'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'A statistically powered sample size was not obtained; Two secondary objectives (compare costs \\& compare differences in OR efficiency as a function of institution type \\& geographic location) could not be assessed as originally intended by the protocol'}}, 'adverseEventsModule': {'timeFrame': 'Intraoperative', 'eventGroups': [{'id': 'EG000', 'title': 'TruMatch™ Personalized Solutions', 'description': "Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions Instrument: TruMatch™ Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch™ is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon", 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Conventional Total Knee Replacement', 'description': 'Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Total Knee Replacement', 'description': 'Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments'}, {'id': 'OG001', 'title': 'TruMatch® Personalized Solutions', 'description': "Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon."}], 'classes': [{'categories': [{'measurements': [{'value': '65.8', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '67.3', 'spread': '20.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.54', 'groupIds': ['OG000', 'OG001'], 'groupDescription': "The null hypothesis was no difference in skin-to-skin time. The alternative hypothesis was that the TruMatch group time was less than the conventional group. Statistical power was anticipated to be 86% with 40 enrolled subjects based upon a Cohen's D effect size of 1. The Sponsor had difficulty identifying and recruiting sites suitable for participation. The statistically required sample size (N=40) was therefore not obtained, causing the group comparison to be statistically underpowered.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative (Time from first incision to first stitch)', 'description': 'Skin-to skin time for conventional versus TruMatch® primary total knee replacements (recorded by Investigator on Operative case report forms).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Operating Room Setup - Operating Room Cleaned up From Previous Case to Surgical Draping Complete', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Total Knee Replacement', 'description': 'Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments'}, {'id': 'OG001', 'title': 'TruMatch® Personalized Solutions', 'description': "Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon."}], 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'spread': '15.0', 'groupId': 'OG000'}, {'value': '28.8', 'spread': '14.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative (Operating Room cleaned up from previous case to surgical draping complete)', 'description': 'Operating Room setup time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis \\[minutes\\]', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Turnover Time (Time to Clean Operating Room After Surgery is Completed)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Total Knee Replacement', 'description': 'Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments'}, {'id': 'OG001', 'title': 'TruMatch® Personalized Solutions', 'description': "Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon."}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative (Time to clean Operating Room after surgery is completed)', 'description': 'Turnover Time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis \\[minutes\\].', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 site (9 subjects) was excluded from Turnover Time analysis as this substep could not be accurately assessed due to unexpected difficulties during video collection.'}, {'type': 'SECONDARY', 'title': 'Costs Associated With Conventional Versus TruMatch® Total Knee Arthroplasty Surgical Procedures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Total Knee Replacement', 'description': 'Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments'}, {'id': 'OG001', 'title': 'TruMatch® Personalized Solutions', 'description': "Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon."}], 'timeFrame': 'Intraoperative (Total duration of procedure)', 'description': 'Compare costs associated with surgery using conventional surgical technique versus TruMatch® primary total knee replacements .', 'reportingStatus': 'POSTED', 'populationDescription': 'No cost data were collected, resulting in a sample size of 0.'}, {'type': 'SECONDARY', 'title': 'To Compare the Differences in Operating Room Efficiency as a Function of Institution Type and Geographical Location', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Total Knee Replacement', 'description': 'Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments'}, {'id': 'OG001', 'title': 'TruMatch® Personalized Solutions', 'description': "Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon."}], 'timeFrame': 'Intraoperative', 'reportingStatus': 'POSTED', 'populationDescription': 'No operating room efficiency data was analyzed as a function of geography and institution, resulting in a sample size of 0.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Conventional Total Knee Replacement', 'description': 'Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments'}, {'id': 'FG001', 'title': 'TruMatch® Personalized Solutions', 'description': "Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Surgery was cancelled by patient', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TruMatch® Personalized Solutions', 'description': "Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch® Personalized Solutions Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon"}, {'id': 'BG001', 'title': 'Conventional Total Knee Replacement', 'description': 'Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.9', 'spread': '12.9', 'groupId': 'BG000'}, {'value': '62.7', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '62.8', 'spread': '10.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All subjects who were consented prior to surgery were included in the analysis of baseline characteristics.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2013-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-09', 'studyFirstSubmitDate': '2010-12-02', 'resultsFirstSubmitDate': '2014-06-25', 'studyFirstSubmitQcDate': '2011-02-22', 'lastUpdatePostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-08-26', 'studyFirstPostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements', 'timeFrame': 'Intraoperative (Time from first incision to first stitch)', 'description': 'Skin-to skin time for conventional versus TruMatch® primary total knee replacements (recorded by Investigator on Operative case report forms).'}], 'secondaryOutcomes': [{'measure': 'Operating Room Setup - Operating Room Cleaned up From Previous Case to Surgical Draping Complete', 'timeFrame': 'Intraoperative (Operating Room cleaned up from previous case to surgical draping complete)', 'description': 'Operating Room setup time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis \\[minutes\\]'}, {'measure': 'Turnover Time (Time to Clean Operating Room After Surgery is Completed)', 'timeFrame': 'Intraoperative (Time to clean Operating Room after surgery is completed)', 'description': 'Turnover Time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis \\[minutes\\].'}, {'measure': 'Costs Associated With Conventional Versus TruMatch® Total Knee Arthroplasty Surgical Procedures', 'timeFrame': 'Intraoperative (Total duration of procedure)', 'description': 'Compare costs associated with surgery using conventional surgical technique versus TruMatch® primary total knee replacements .'}, {'measure': 'To Compare the Differences in Operating Room Efficiency as a Function of Institution Type and Geographical Location', 'timeFrame': 'Intraoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Arthroplasties, Knee Replacement', 'Arthroplasties, Replacement, Knee', 'Arthroplasty, Knee Replacement', 'Knee Replacement Arthroplasties', 'Knee Replacement Arthroplasty', 'Knee Replacement, Total', 'Replacement Arthroplasties, Knee', 'Replacement Arthroplasty, Knee', 'Replacement, Total Knee', 'Total Knee Replacement'], 'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'This study is designed to compare the surgical efficiency of TruMatch® Personalized Solutions surgical technique compared to conventional surgical technique. Specifically, the purpose of this study is to collect time data to enhance the existing economic model.', 'detailedDescription': 'The study is designed as a prospective, multi-center, controlled, non-randomized, clinical investigation to compare the efficiency of TruMatch® Personalized Solutions surgical technique compared to conventional surgical technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is male or female and between the ages of 18 and 80 years old, inclusive.\n* Subject requires a primary total knee replacement and is considered by the Investigator to be suitable for the specific knee prosthesis identified in the protocol.\n* Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy\n* Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation, and co-operate with investigational procedures.\n* Subject, who, in the opinion of the Clinical Investigator, are suitable for implantation using TruMatch™ instrumentation. For example, no femoral nails/bone plates that extend into the knee, ie. within 8cm of joint line; no metal device that could cause CT scatter about the knee and no deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture are consistent with TruMatch™ instrumentation.\n\nExclusion Criteria:\n\n* The Subject is a woman who is pregnant or lactating.\n* The Subject has participated in a clinical investigation with an investigational product in the last 3 months.\n* The Subject is currently involved in any personal injury litigation, medical-legal or worker's compensations claims.\n* The Subject has previously had a prosthetic knee replacement device (any type) of the affected knee.\n* The Subject requires simultaneous bilateral total knee replacements.\n* The Subject had a contralateral TKA and that knee was previously entered in the study.\n* Subject in whom the surgeon intends to implant a knee prosthesis that is not in the PFC Sigma primary knee system.\n* Subject who has inflammatory arthritis.\n* Subject who has a Body Mass Index (BMI) of ≥ 40. (Please see Table 2-1: Definition of Terms, for BMI definition and calculation formulas)."}, 'identificationModule': {'nctId': 'NCT01301950', 'briefTitle': 'Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'DePuy Orthopaedics'}, 'officialTitle': 'Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty Using TruMatch® Personalized Solutions Compared to Conventional Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '08004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TruMatch® Personalized Solutions', 'description': 'Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch® Personalized Solutions (Custom Patient Instrumentation)', 'interventionNames': ['Other: Custom Patient Instrumentation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Total Knee Replacement', 'description': 'Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments', 'interventionNames': ['Other: Conventional Instruments']}], 'interventions': [{'name': 'Custom Patient Instrumentation', 'type': 'OTHER', 'otherNames': ['TruMatch® Personalized Solutions'], 'description': "TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation (CPI). TruMatch™ is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon", 'armGroupLabels': ['TruMatch® Personalized Solutions']}, {'name': 'Conventional Instruments', 'type': 'OTHER', 'description': 'Total Knee Arthroplasty implanted using conventional instruments (non-CPI) and surgical technique.', 'armGroupLabels': ['Conventional Total Knee Replacement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46158', 'city': 'Mooresville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Center for Hip and Knee Surgery', 'geoPoint': {'lat': 39.61282, 'lon': -86.37416}}, {'zip': '74006', 'city': 'Bartlesville', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Pinnacle Orthopaedics', 'geoPoint': {'lat': 36.74731, 'lon': -95.98082}}, {'zip': '20190', 'city': 'Reston', 'state': 'Virginia', 'country': 'United States', 'facility': 'Commonwealth Orthopaedics', 'geoPoint': {'lat': 38.96872, 'lon': -77.3411}}], 'overallOfficials': [{'name': 'Carl Painter', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pinnacle Orthopaedics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DePuy Orthopaedics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}