Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-01-03 @ 6:50 AM
Study NCT ID:
NCT06678750
Status:
WITHDRAWN
Last Update Posted:
2025-10-17
First Post:
2024-10-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Clinical Study Evaluating the Newton™ TKA Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study funding not finalized', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-14', 'studyFirstSubmitDate': '2024-10-30', 'studyFirstSubmitQcDate': '2024-11-06', 'lastUpdatePostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction with TKA using patient reported KOOS JR Questionnaire', 'timeFrame': 'Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op', 'description': 'The KOOS, JR combines the pain, symptoms, and functional limitations into a single score.'}, {'measure': 'Patient satisfaction with TKA using Oxford Knee Score (OKS) Questionnaire', 'timeFrame': 'Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op', 'description': 'The OKS is a patient reported questionnaire that measures function and pain with a single score.'}, {'measure': 'Patient satisfaction with TKA using Forgotten Joint Score (FJS) Questionnaire', 'timeFrame': 'Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op', 'description': 'The Forgotten Joint Score assesses the ability of the patient to forget about their joint given successful treatment by assigning a single score to a series of questions.'}, {'measure': 'Patient recovery from TKA using time from hospital stay to discharge', 'timeFrame': 'Post-op measure in hours', 'description': 'The time of in-patient hospital stay will be measured (in hours).'}, {'measure': 'Patient recovery from TKA by measuring number of outpatient visits', 'timeFrame': 'One year post-op', 'description': 'Number of outpatient visits (scheduled and unscheduled)'}, {'measure': 'Patient recovery from TKA by measuring number of PT visits', 'timeFrame': 'One year post-op', 'description': 'Number of post-op PT visits'}, {'measure': 'Patient recovery from TKA by measuring medication consumption', 'timeFrame': 'One year post-op', 'description': 'Post-op, prescription medication will be recorded in number of pills and dosage'}, {'measure': 'Patient recovery from TKA by measuring use of assisted walking devices', 'timeFrame': 'One year post-op', 'description': 'Patient recovery from TKA by measuring the number of days using an assisted walking device following surgery.'}], 'secondaryOutcomes': [{'measure': 'Knee alignment and soft tissue balance', 'timeFrame': 'Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op', 'description': 'Telemetric x-rays will be used to assess the angles and evaluate the joint line status pre- and post-operatively.'}, {'measure': 'Knee alignment and soft tissue balance', 'timeFrame': 'One time (during surgery)', 'description': 'Patients receiving a TKA NewtonTM Knee, soft-tissue balance will be measured intra-operatively by placing the Newton distractor at the trial reduction stage and acquiring the corresponding joint laxities through the arc of motion.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Total Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'Evaluation of clinical outcomes and patient recovery in patients receiving TKA with traditional instrumentation systems compared to full arc of motion gap balancing using the Newton TM Knee Protocol', 'detailedDescription': 'The purpose of this study is to evaluate patient outcomes, recovery, and patient/surgeon satisfaction of individuals who undergo a total knee arthroplasty (TKA) using mechanical instrumentation (non-navigated) compared to individuals who undergo a TKA with a tibia first gap balancing surgical workflow using the NewtonTM Knee Protocol and navigation-assistance (ExachtechGPS®).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of Kaplan Joint Center, Newton Wellesley Hospital scheduled for TKA with a specific implant\n\nExclusion Criteria:\n\n* Patients may be excluded due to some medical conditions'}, 'identificationModule': {'nctId': 'NCT06678750', 'briefTitle': 'A Prospective Clinical Study Evaluating the Newton™ TKA Protocol', 'organization': {'class': 'OTHER', 'fullName': 'Newton-Wellesley Hospital'}, 'officialTitle': 'Evaluation of Clinical Outcomes and Patient Recovery in Patients Receiving TKA With Traditional Instrumentation Systems Compared to Full Arc of Motion Gap Balancing Using the Newton™ Knee Protocol: A Prospective Clinical Study', 'orgStudyIdInfo': {'id': '2024p002323'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Comparison Group: TKA patients whose surgery was conducted with traditional, manual instrumentation', 'description': 'The comparison groups includes TKA patients whose surgery is conducted using traditional, manual, non-navigated instrumentation.', 'interventionNames': ['Procedure: TKA']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group: Patients whose TKA surgery was conducted using Exactech GPS navigation', 'description': 'The intervention group will include TKA patients whose surgery is conducted with a tibia first gap balancing surgical workflow using the NewtonTM Knee Protocol and navigation-assistance (ExachtechGPS®).', 'interventionNames': ['Device: TKA using computer navigation']}], 'interventions': [{'name': 'TKA using computer navigation', 'type': 'DEVICE', 'description': 'TKA using Exactech GPS Newton Knee protocol', 'armGroupLabels': ['Intervention Group: Patients whose TKA surgery was conducted using Exactech GPS navigation']}, {'name': 'TKA', 'type': 'PROCEDURE', 'description': 'TKA using manual instrumentation', 'armGroupLabels': ['Comparison Group: TKA patients whose surgery was conducted with traditional, manual instrumentation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02468', 'city': 'Newton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Kaplan Joint Center, Newton Wellesley Hospital', 'geoPoint': {'lat': 42.33704, 'lon': -71.20922}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Newton-Wellesley Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Exactech', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christopher M. Melnic, MD', 'investigatorAffiliation': 'Newton-Wellesley Hospital'}}}}