Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-04-16 @ 9:56 PM
Study NCT ID:
NCT03106558
Status:
UNKNOWN
Last Update Posted:
2017-04-10
First Post:
2017-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Market Study of Robotic-Arm Assisted Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-04', 'studyFirstSubmitDate': '2017-02-07', 'studyFirstSubmitQcDate': '2017-04-04', 'lastUpdatePostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Component alignment', 'timeFrame': '6 weeks post knee arthroplasty', 'description': 'CT scan measurement'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'This is an early user evaluation of the robotic-assisted total knee arthroplasty platform. The objective of this surgeon group is to capture data on the defined objectives and provide Stryker with feedback.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient requires primary total knee surgery\n* Patient is willing and able to comply with postoperative follow-up requirements and self evaluations\n* Patient is willing to sign an IRB approved informed consent\n* Patient is at least 18 years of age\n\nExclusion Criteria:\n\n* Patient has a BMI \\> 50\n* Patient is skeletally immature\n* Patient has an active infection or suspected infection in or about the joint\n* Bone stock that is inadequate to support fixation of the prosthesis\n* Neuromuscular disorders, muscular atrophy or vascular deficiency in the affected limb rendering the procedure unjustified.\n* Patients with mental or neurological conditions which may be incapable of following instructions.\n* Blood supply limitations\n* Collateral ligament insufficiency.\n* Patients with prior HTOs or Unis.'}, 'identificationModule': {'nctId': 'NCT03106558', 'briefTitle': 'Post-Market Study of Robotic-Arm Assisted Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Rothman Institute Orthopaedics'}, 'officialTitle': 'Post-Market Study of Robotic-Arm Assisted Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '2017WHoz'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Manual instrument total knee replacement', 'interventionNames': ['Device: Total Knee Arthroplasty using Manual Instrumentation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Robitic arm total knee replacement', 'interventionNames': ['Device: Total Knee Arthroplasty using Robotic Arm']}], 'interventions': [{'name': 'Total Knee Arthroplasty using Manual Instrumentation', 'type': 'DEVICE', 'armGroupLabels': ['Manual instrument total knee replacement']}, {'name': 'Total Knee Arthroplasty using Robotic Arm', 'type': 'DEVICE', 'armGroupLabels': ['Robitic arm total knee replacement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30606', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'Athens Orthopedic Clinic', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}, {'zip': '08234', 'city': 'Egg Harbor', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rothman Institute', 'geoPoint': {'lat': 39.38646, 'lon': -74.60361}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rothman Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rothman Institute Orthopaedics', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stryker Orthopaedics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}