Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
Study NCT ID:
NCT06670651
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-10
First Post:
2024-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LinkSymphoKnee (LSK) Total Knee Replacement System Study - Ultra-congruent (UC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'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': 'D014947', 'term': 'Wounds and Injuries'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2031-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2024-10-31', 'studyFirstSubmitQcDate': '2024-10-31', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR) - change from baseline', 'timeFrame': '1 year postoperative', 'description': 'Patient-reported outcome measure (PROM) that assesses knee health based on questions about pain, stiffness, function, and daily activities. Minimum score = 0. Maximum score = 100. Higher score means a better outcome.'}, {'measure': 'Revision rate', 'timeFrame': '5 years postoperative', 'description': 'Evaluates how often patients require additional surgery to remove or replace the knee arthroplasty device components.'}], 'secondaryOutcomes': [{'measure': 'Knee Society Score - change from baseline', 'timeFrame': 'postoperative intervals through 5 years', 'description': "A rating scale that measures the outcome of a patient's knee replacement surgery by assessing objective and subjective outcomes, including pain, range of motion, stability, walking distance, and ability to climb stairs, and also patient satisfaction and expectations. Minimum score = 0. Maximum score = 100. Higher score means better outcome."}, {'measure': 'PROMIS Global Health Score - change from baseline', 'timeFrame': 'postoperative intervals through 5 years', 'description': 'PROMIS Global Health measures physical function, pain, fatigue, emotional distress, and social health. The raw score minimum is 7 and maximum is 35. Higher score means better outcome.'}, {'measure': 'Surgery Satisfaction Score', 'timeFrame': '1 and 5 years postoperative', 'description': "Measures a patient's satisfaction with a surgical procedure based on questions about pain control and daily activities. Minimum score is 0. Maximum score is 10. Higher score means better outcome."}, {'measure': 'Forgotten Joint Score', 'timeFrame': 'postoperative intervals through 5 years', 'description': "Measures a patient's awareness of their artificial knee joint. Minimum score is 0. Maximum score is 100. Higher score means better outcome."}, {'measure': 'Knee Society Roentgenographic Evaluation and Scoring System', 'timeFrame': 'Through 2 years postoperative', 'description': 'Evaluates radiographic signs of device stability. 3 zones are assigned to evaluate the patella component. 5-7 zones are assigned to evaluate the tibia and femur components. Radiolucencies are evaluated for size, location, and progression over time. Changes in implant position and/or radiolucencies that are large, continuous, or progressive over time signify possible or impending implant failure.'}, {'measure': 'PROMIS Pain Interference Score - change from baseline', 'timeFrame': 'postoperative intervals through 5 years', 'description': "The score measures how pain affects a person's life. The raw score minimum is 6 and maximum is 30. A lower score means a better outcome."}, {'measure': 'PROMIS Physical Function Score - change from baseline', 'timeFrame': 'postoperative intervals through 5 years', 'description': "The score measures a person's ability to perform activities. The raw score minimum is 11 and maximum is 72.5. A higher score means a better outcome."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['primary total knee arthroplasty'], 'conditions': ['Osteoarthritis (OA) of the Knee', 'Fracture', 'Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'To collect information about implant performance and patient clinical outcomes in patients undergoing primary total knee arthroplasty with the LinkSymphoKnee total knee replacement system with ultra-congruent tibial bearing surface.', 'detailedDescription': 'The study will collect outcomes data on up to 600 patients from up to 3 sites using a legally marketed device according to its labeled intended use.\n\nThe study will collect:\n\n1. KOOS-JR\n2. Knee Society Score (KSS), 2011\n3. PROMIS Global Health\n4. PROMIS Physical Function\n5. PROMIS Pain Interference\n6. Surgery Satisfaction\n7. Forgotten Joint Score\n8. Radiographic findings\n9. Revisions.\n\nRadiographic evaluations will be done through postoperative year 2. Other outcomes will be evaluated up to postoperative year 5.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients seeking primary total knee arthroplasty from the participating surgeon investigators', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years or older, and skeletally mature; and\n* Undergoing a primary TKA for one or both knees using the cemented LinkSymphoKnee knee system as part of the surgeon's standard of care.\n* Able to read and understand English (because patient-reported outcome questionnaires are not validated for all potential other languages).\n\nExclusion Criteria:\n\n* 80 years of age or older,\n* Women who are pregnant at the time of surgery,\n* History of joint sepsis,\n* Bone defect that requires grafting,\n* Previous history of bone disease (e.g., severe osteoporosis or osteomalacia) which in the surgeon's opinion is severe enough to compromise device fixation,\n* Systemic conditions affecting bone density (e.g., inflammatory arthritis or renal disease) which in the surgeon's opinion are severe enough to compromise device fixation,\n* A poorly functioning contralateral total knee replacement or a contralateral revision regardless of function."}, 'identificationModule': {'nctId': 'NCT06670651', 'briefTitle': 'LinkSymphoKnee (LSK) Total Knee Replacement System Study - Ultra-congruent (UC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'LinkBio Corp.'}, 'officialTitle': 'LinkSymphoKnee (LSK) Total Knee Replacement System Study - Ultra-congruent (UC)', 'orgStudyIdInfo': {'id': 'LB24001-LSKUC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'total knee arthroplasty device', 'type': 'DEVICE', 'description': 'total knee arthroplasty device with ultracongruent bearing surface'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'OrthoAlabama Spine & Sports', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '60048', 'city': 'Libertyville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Bone and Joint Institute', 'geoPoint': {'lat': 42.28308, 'lon': -87.95313}}], 'overallOfficials': [{'name': 'Brian Schwartz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Illinois Bone & Joint Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LinkBio Corp.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}