Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-05 @ 6:20 PM
Study NCT ID:
NCT02058069
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2014-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Robotic Arm Assisted Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michael.conditt@stryker.com', 'phone': '7132408675', 'title': 'Michael Conditt', 'organization': 'MAKO Surgical Corp.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Subject enrollment to end of study.', 'description': 'Participants = knees', 'eventGroups': [{'id': 'EG000', 'title': 'Robotic Assisted Total Knee Arthroplasty', 'description': "Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.\n\nNote regarding serious AEs:\n\nAdhesions and arthrofibrosis are surgical complications that can result from knee surgery and present as stiffness and restriction of ROM. Reasons for stiffness and restriction of ROM after TKA are multifactorial and may be influenced by factors such as the patient's overall health, motivation, and compliance to their rehabilitation regimen. The Principal Investigator and study Investigators stated these adverse events are not related to the use of the Investigational Device.", 'otherNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'seriousNumAffected': 9}], 'seriousEvents': [{'term': 'Arthrofibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intra-Operative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Robotic Assisted Total Knee Arthroplasty', 'description': 'Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Subject will be assessed for these complications intra-operatively. The assessment occurs after the surgeon has completed the surgical procedure, but while the subject is still in the operating room with the surgeon.', 'description': 'Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.', 'unitOfMeasure': 'intra-operative complications', 'reportingStatus': 'POSTED', 'populationDescription': 'participants = knees.'}, {'type': 'PRIMARY', 'title': 'Intra-Operative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Robotic Assisted Total Knee Arthroplasty', 'description': 'Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Subjects will be assessed for incidence of intra-operative complications at the conclusion of their hospital stay, or an average of 3 days post-operatively.', 'description': 'Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.', 'unitOfMeasure': 'intra-operative complications', 'reportingStatus': 'POSTED', 'populationDescription': 'participants = knees.'}, {'type': 'PRIMARY', 'title': 'Intra-Operative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Robotic Assisted Total Knee Arthroplasty', 'description': 'Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Rare Adverse Event Rate', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciUpperLimit': '0.0331', 'estimateComment': "If the upper bound is \\<0.126 then the primary composite safety endpoint is met. After the surgeon completed the procedure, at the conclusion of the participant's hospital stay, and 3 months post-operative were used in this single analysis.", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The Alternative Hypothesis: The Investigational Device (RIO) true event rate is non-inferior to 0.066 (event rate for manual TKA) with a non-inferiority margin of 0.06. The 0.066 rate is based on literature and 0.06 was determined in consultation with FDA.'}], 'paramType': 'NUMBER', 'timeFrame': '3 Month Post Op', 'description': 'Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.', 'unitOfMeasure': 'intra-operative complications', 'reportingStatus': 'POSTED', 'populationDescription': 'participants = knees.'}, {'type': 'SECONDARY', 'title': 'Change in the Radiographic Assessment of Limb Alignment From Pre-Operative to 3 Months Post-Operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Robotic Assisted Total Knee Arthroplasty', 'description': 'Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.54', 'spread': '1.01', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-op plan, 3 Month Post Op', 'description': 'Radiographic limb alignment of the operative knee according to the technique defined by Barrack et al. was assessed at the 3 month post-operative follow-up by two independent reviewers. The measured post-operative limb alignment was to be compared to the planned pre-operative limb alignment as extracted from the system log file.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 89 patients who received a robotic assisted total knee arthroplasty as part of the IDE, 2 patients were excluded from analysis for the Secondary Endpoint only due to issues related to the accurate measurement of limb alignment from the radiographs available (not for reasons involving the surgical procedure or clinical outcomes).'}, {'type': 'SECONDARY', 'title': 'Participants With Limb Alignment Difference <4.38 Degrees', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Robotic Assisted Total Knee Arthroplasty', 'description': 'Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Alignment Difference <4.38 Degrees', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '0.966', 'estimateComment': 'Estimation Parameter is: proportion of participants with limb alignment difference \\<4.38 degrees If the lower bound is \\>0.95 then the assessment passes.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The analysis was performed using standard OC curves generated using Sample Size Analyzer® version 2.0 by Taylor Enterprise Inc. (Dr. Wayne A. Taylor).'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-op Plan, 3 Month Post Op', 'description': 'The difference between the actual 3 month limb alignment was compared to the pre-op planned alignment. Any measurement difference \\<4.38 was considered a success; \\>4.38 degrees was considered a failure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants = knees'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient Satisfaction - Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Robotic Assisted Total Knee Arthroplasty', 'description': 'Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.'}], 'classes': [{'categories': [{'measurements': [{'value': '-33.1', 'spread': '20.04', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-33.1', 'ciUpperLimit': '-29.6', 'estimateComment': 'If the upper bound is less than -9, then non-inferiority holds.', 'groupDescription': 'Change from pre-op to 3 months', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The upper bound for the one-sided 95% confidence interval will be compared with -9. If the upper bound is less than -9, then non-inferiority holds.'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Op, 3 Month Post Op [change assessed between the two time periods]', 'description': 'The WOMAC collects information specific to osteoarthritis outcomes. The patient-response questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and function. Each question is scored from 0 to 4 for each set of factors, with 0 indicating no pain, stiffness, or limit in function, and 4 indicating extreme pain, stiffness, or limit in function. Total WOMAC scores range from 0 to 96 with lower values representing better outcomes.\n\nThe posted mean, noted as a negative number, represents the mean DECREASE in total WOMAC score from pre-operative to 3 month post-operative patient assessment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants = knees.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Robotic Assisted Total Knee Arthroplasty', 'description': 'Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.\n\n"Participants" throughout this posting is equivalent to the number of knees.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Exclusion due to implant size', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Robotic Assisted Total Knee Arthroplasty', 'description': 'Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.78', 'spread': '8.49', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-21', 'studyFirstSubmitDate': '2014-02-03', 'resultsFirstSubmitDate': '2016-01-14', 'studyFirstSubmitQcDate': '2014-02-06', 'lastUpdatePostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-01-14', 'studyFirstPostDateStruct': {'date': '2014-02-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient Satisfaction - Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': 'Pre-Op, 3 Month Post Op [change assessed between the two time periods]', 'description': 'The WOMAC collects information specific to osteoarthritis outcomes. The patient-response questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and function. Each question is scored from 0 to 4 for each set of factors, with 0 indicating no pain, stiffness, or limit in function, and 4 indicating extreme pain, stiffness, or limit in function. Total WOMAC scores range from 0 to 96 with lower values representing better outcomes.\n\nThe posted mean, noted as a negative number, represents the mean DECREASE in total WOMAC score from pre-operative to 3 month post-operative patient assessment.'}], 'primaryOutcomes': [{'measure': 'Intra-Operative Complications', 'timeFrame': 'Subject will be assessed for these complications intra-operatively. The assessment occurs after the surgeon has completed the surgical procedure, but while the subject is still in the operating room with the surgeon.', 'description': 'Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.'}, {'measure': 'Intra-Operative Complications', 'timeFrame': 'Subjects will be assessed for incidence of intra-operative complications at the conclusion of their hospital stay, or an average of 3 days post-operatively.', 'description': 'Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.'}, {'measure': 'Intra-Operative Complications', 'timeFrame': '3 Month Post Op', 'description': 'Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.'}], 'secondaryOutcomes': [{'measure': 'Change in the Radiographic Assessment of Limb Alignment From Pre-Operative to 3 Months Post-Operative', 'timeFrame': 'pre-op plan, 3 Month Post Op', 'description': 'Radiographic limb alignment of the operative knee according to the technique defined by Barrack et al. was assessed at the 3 month post-operative follow-up by two independent reviewers. The measured post-operative limb alignment was to be compared to the planned pre-operative limb alignment as extracted from the system log file.'}, {'measure': 'Participants With Limb Alignment Difference <4.38 Degrees', 'timeFrame': 'Pre-op Plan, 3 Month Post Op', 'description': 'The difference between the actual 3 month limb alignment was compared to the pre-op planned alignment. Any measurement difference \\<4.38 was considered a success; \\>4.38 degrees was considered a failure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis', 'Rheumatoid Arthritis', 'Post-traumatic Arthritis']}, 'descriptionModule': {'briefSummary': 'The Investigation will be conducted as a single-submission, multi-center study with approval from and in compliance of the Western Institutional Review Board (WIRB).\n\nThe overall objective of this Investigation is to assess the safety and effectiveness of the Robotic Arm Interactive Orthopedic System (RIO) Total Knee Arthroplasty Application. Specifically, the study objectives are classified as follows:\n\n* Primary Objective: Surgeon assessment of standardized TKA complications both intra-operatively and at short term follow up.\n* Secondary Objective: Radiographic assessment of post-operative limb alignment.\n* Supporting Objective: Patient assessment of post-operative function and satisfaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subjects may be recruited in to the Investigation.\n* Age - The subject must be at least 21 years of age and skeletally mature as demonstrated radiographically by complete closure of the distal femoral and proximal tibial epiphyses.\n* Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.\n* Subjects who, in the opinion of the Investigators and Approved Study Staff, are able to understand this Investigation and cooperate with the Investigation procedures and are willing to comply with all the required post-operative follow-ups.\n* Subjects who require a total knee arthroplasty for primary surgical management of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, moderate deformities or femoral condyle osteonecrosis as defined below.\n* Osteoarthritis: Kellgren-Lawrence Grade 3 or higher, with clinical history of an absence of major trauma to the joint; symptoms of pain, stiffness, swelling, and/or loss of motion; and with radiographic evidence of joint space narrowing, sub-chondral sclerosis, or peripheral osteophytes.\n* Post-Traumatic Arthritis: Kellgren-Lawrence Grade 3 or higher, with a clinical history of trauma to the targeted knee and subsequent pain, stiffness, swelling and loss of motion; and with radiographic evidence of joint space narrowing, sub-chondral sclerosis, or peripheral osteophytes.\n* Rheumatoid Arthritis: American College of Rheumatology classification score of 6 or higher, with a clinical history that demonstrates the following: morning stiffness for at least 1 hour and present for at least 6 weeks, swelling, loss of motion, and/or serum rheumatoid factor; and radiographic findings of narrow joint space, peri-articular osteopenia, and/or per-articular erosions.\n* Moderate Deformities: Moderate varus, valgus, flexion, or post-traumatic deformities of no more than 15° assessed radiographically. Moderate recurvatum of no more than 8° assessed radiographically.\n* Femoral Condyle Osteonecrosis: Loss of blood supply in the femoral condyle characterized by sudden onset of pain, possibly triggered by a specific seemingly routine activity or minor injury. Pain is often increased with activity and at night time and may cause swelling of the knee and sensitivity to touch and pressure and may result in limited motion. Confirmed by a bone scan, MRI, and/or x-ray.\n* Subjects whose anatomy is appropriate for the available range of implant sizes.\n\nExclusion Criteria:\n\n* Patients who have had previous surgical procedures requiring implantation of hardware in their operative side knee, hip, or ankle that would result in metal artifact scatter in a CT scan.\n* Patients who have a fracture malunion of the distal femur or proximal tibia within 12cm of the knee center, assessed radiographically.\n* Patients who are pregnant, may become pregnant during the course of the Investigation, or are currently lactating.\n* Patients with allergies or suspected sensitivity to any patient-contacting component of the investigational device or the implant to be used in the study as listed below:\n* Femoral component: Cobalt Chromium alloy (CoCr)\n* Tibial component: Titanium alloy (Ti6Al4V)\n* Tibial inserts and patella component: Vitamin E infused ultra-high molecular weight polyethylene (UHMWPE)\n* Saw blade: 440C Stainless Steel\n* Patients who require bilateral total knee arthroplasty.\n* Patients who are currently on medical leave from their employment due to Workmen's Compensation.\n* Patients who are currently state or federal prisoners.\n* Patients who are currently Wards of the state.\n* Patients who are at high risk for poor healing or confounding outcomes or at excessive risk for surgery i.e.: clinically significant/being actively treated for renal, hepatic, cardiac, hematologic, or neurologic disease or poorly controlled diabetes (HbA1c \\> 10 mg/dL) or previous history of joint infection.\n* Patients who are known drug or alcohol abusers or with psychological disorders as defined by DSM V that could affect follow-up care or treatment outcomes.\n* Patients who are currently involved in another clinical study with an investigational device.\n* Patients with current litigation pending related to medical treatment of any sort."}, 'identificationModule': {'nctId': 'NCT02058069', 'briefTitle': 'Robotic Arm Assisted Total Knee Arthroplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'MAKO Surgical Corp.'}, 'officialTitle': 'Robotic Arm Assisted Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'RIOTKA_2014'}, 'secondaryIdInfos': [{'id': '20131148', 'type': 'OTHER', 'domain': 'WIRB Protocol'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robotic Assisted Total Knee Arthroplasty', 'interventionNames': ['Device: Robotic Arm Assisted Total Knee Arthroplasty']}], 'interventions': [{'name': 'Robotic Arm Assisted Total Knee Arthroplasty', 'type': 'DEVICE', 'otherNames': ['MAKO Surgical Corp', 'RIO Total Knee Arthroplasty Application', 'MAKOplasty Total Knee Arthroplasty'], 'description': 'The total knee implant system used for this study was the Kinetis implant system (MAKO Surgical Corp.).', 'armGroupLabels': ['Robotic Assisted Total Knee Arthroplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94574', 'city': 'St. Helena', 'state': 'California', 'country': 'United States', 'facility': 'Coon Joint Replacement Institue; St. Helena Hospital', 'geoPoint': {'lat': 38.50519, 'lon': -122.47026}}, {'zip': '33637', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Orthopedic Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '77024', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Bone and Joint Research Foundation; Memorial Hermann Memorial City Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Kenneth Gustke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida Orthopedic Institute, Tampa General Hospital'}, {'name': 'Thomas Coon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Coon Joint Replacement Institute, St. Helena Hospital'}, {'name': 'Stefan Kreuzer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Bone and Joint Research Foundation, Memorial Hermann Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MAKO Surgical Corp.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}