Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-28 @ 6:23 PM
Study NCT ID:
NCT05744895
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-25
First Post:
2023-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MAKO Total Knee Artroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-12-16'}], 'estimatedResultsFirstSubmitDate': '2025-12-16'}}, '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-03', 'size': 1020708, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-02-01T15:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2023-02-01', 'studyFirstSubmitQcDate': '2023-02-15', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early recovery', 'timeFrame': '4 weeks', 'description': 'To determine if Robotic-arm assisted TKA (RA-TKA) allows for earlier recovery than manual TKA (MI-TKA). This will be measured by weekly VAS pain score.\n\n\\[Time Frame: 1 day- post op\\]'}], 'secondaryOutcomes': [{'measure': 'Post op EOS measurements for alignment', 'timeFrame': '1 year', 'description': 'To determine if Robotic-arm assisted TKA (RA-TKA) allows for more accurate component placement than manual TKA (MI-TKA). units of measurement will be inches.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the early clinical and radiographic outcomes of robotically assisted total knee arthroplasty with the MAKO surgical robot using the Triathlon knee system. Results of this study will be compared to those of a previously published cohort of patients from this institution who underwent TKA using non-robotic, manual instruments.\n\nMAKO TKA patients will be given Fitbits and the Focus Motion Knee Brace to capture the data listed in attachment section. The results of this data will be compared to the control group to see if there is or there is not a difference in clinical outcomes with patients receiving Total knee surgery using the MAKO surgical robot versus those who got Total knee surgery without the MAKO robot.', 'detailedDescription': 'Research objectives:\n\nThe purpose of this study is to determine the early clinical and radiographic outcomes of robotically assisted total knee arthroplasty with the MAKO surgical robot using the Triathlon knee system. Mean weekly VAS pain score during the first 4 weeks is the primary end point. Results of this study will be compared to prospective cohort of patients in the IRB study 201805014 from this institution who underwent TKA using non-robotic, manual instruments\n\nPrimary Hypothesis: Patients receiving robotic TKA will have better early recovery, including lower mean weekly VAS pain score for the first 4 weeks postoperatively and higher functional outcome scores, than the manual TKA historical cohort.\n\nSecondary Hypothesis:\n\nPatients receiving robotic TKA will have more accurate component position and alignment than the manual TKA historical cohort.\n\nPotential Contribution: This study would give us a better understanding of the clinical and radiographic outcomes of patients receiving robotic TKA versus manual TKA. It will identify potential advantages and disadvantages of robotic TKA using the MAKO surgical robot.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We propose to enroll patients that are scheduled for a MAKO Total knee arthroplasty', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planning to undergo Unilateral primary total knee arthroplasty\n* 18 and up\n* Willing to sign informed consent\n* Willing to return for all follow-up visits\n* Smartphone or tablet device capable of running the Fitbit andFocusMotion platform\n\nExclusion Criteria:\n\n* BMI \\> 45\n* Inflammatory arthritis\n* Narcotic use greater than 5 days per week\n* Walking aid for musculoskeletal or neurologic issue other than operative joint\n* Bilateral total knee arthroplasty\n* Patient with an active infection or suspected infection in the operative joint\n* The absolute and relative contraindications stated in the FDA cleared labeling for the device'}, 'identificationModule': {'nctId': 'NCT05744895', 'briefTitle': 'MAKO Total Knee Artroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Early Outcomes of Total Knee Arthroplasty Using the MAKO Surgical Robot and Triathlon Knee', 'orgStudyIdInfo': {'id': '202106145'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prospective Group- Robotic TKA Arm', 'description': 'Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine', 'interventionNames': ['Device: Device: Robotic MAKO total knee', 'Device: FocusMotion knee brace', 'Device: Fitbit tracking device', 'Device: FocusMotion app']}, {'label': 'Control- manual total Knee arthroplasty', 'description': 'Patients who have had a manual total knee arthroplasty'}], 'interventions': [{'name': 'Device: Robotic MAKO total knee', 'type': 'DEVICE', 'description': 'Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine', 'armGroupLabels': ['Prospective Group- Robotic TKA Arm']}, {'name': 'FocusMotion knee brace', 'type': 'DEVICE', 'description': 'Focusmotion knee brace measures range of motion during exercises', 'armGroupLabels': ['Prospective Group- Robotic TKA Arm']}, {'name': 'Fitbit tracking device', 'type': 'DEVICE', 'description': 'Fitbit will measure patients steps, HR, and sleep', 'armGroupLabels': ['Prospective Group- Robotic TKA Arm']}, {'name': 'FocusMotion app', 'type': 'DEVICE', 'description': 'Will survey patients with PROMS', 'armGroupLabels': ['Prospective Group- Robotic TKA Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63141', 'city': 'Creve Coeur', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.66089, 'lon': -90.42262}}], 'overallOfficials': [{'name': 'Charles Hannon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stryker Nordic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}