Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-30 @ 12:21 AM
Study NCT ID:
NCT06821269
Status:
RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Recovery After Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-02-06', 'studyFirstSubmitQcDate': '2025-02-06', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Timed Up and Go (TUG)', 'timeFrame': 'anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery', 'description': 'TUG requires the patient to sit in a chair, stand, walk to a line 3m away, turn, walk back to the chair, and sit again'}, {'measure': '4m and 10m Walking Speed Test', 'timeFrame': 'anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery'}, {'measure': '2-minute Walk', 'timeFrame': 'anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery'}, {'measure': 'Stair Climb Test', 'timeFrame': 'anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery'}, {'measure': 'Y Balance Test', 'timeFrame': 'anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery', 'description': 'The YBT requires the person to balance on one leg whilst simultaneously reaching as far as possible with the other leg in three separate directions: anterior, posterolateral, and posteromedial'}], 'secondaryOutcomes': [{'measure': 'Forgotten Joint Score', 'timeFrame': 'anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery', 'description': "The Forgotten Joint Score (FJS) is a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint."}, {'measure': 'Promis', 'timeFrame': 'anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery', 'description': 'PROMIS stands for Patient Reported Outcomes Measurement Information System, which is a system of highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being'}, {'measure': 'SF36', 'timeFrame': 'anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery', 'description': 'The Short Form 36 Health Survey Questionnaire (SF-36) is used to indicate the health status of particular populations, to help with service planning and to measure the impact of clinical and social interventions.'}, {'measure': 'KOOS', 'timeFrame': 'anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery', 'description': 'The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that helps patients and therapists assess knee injury outcomes over time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthritis Knee']}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to learn about patients' recoveries after receiving total knee arthroplasty (TKA). The main questions it aims to answer are:\n\nDoes robotic-assisted TKA have improved perceived recovery when compared to conventional TKA? Does robotic-assisted TKA lead to improved functional recovery when compared to conventional TKA?\n\nResearchers will compare if robotic-assisted versus conventional procedures lead to different recovery speeds.\n\nParticipants will answer questionnaires and undergo physical therapy testing before and at several timepoints after their procedure.", 'detailedDescription': 'The choice to perform robotic assisted vs manual total knee arthroplasties (TKA) depends on many factors, including but not limited to surgeon training, resource availability, and patient-specific considerations. Recent studies comparing patient outcomes after robotic-assisted and manual total knee arthroplasties have shown mixed results. These studies often focus on future complication rates, radiographic outcomes, or patient reported outcomes between manual and robotic-assisted TKA. Hence, there has been little focus on improvements in functional outcomes after TKA. Combining functional test results, patient reported outcomes, kinematic studies, and data from wearable devices will allow for a comprehensive timeline of recovery speed after either robotic-assisted or manual TKA.\n\nThe overall aim of this proposed study is to quantify functional and PROM at specific timepoints in patients after robotic-assisted or manual total knee arthroplasty (TKA).\n\nThe questions are:\n\n1. Do robotic-assisted revision TKAs have improved functional and perceived recovery when compared to manual revision TKAs?\n2. Do robotic-assisted primary TKAs have improved functional and perceived recovery when compared to manual primary TKAs?\n3. Do robotic-assisted revision TKAs have similar functional and perceived recovery as robotic-assisted primary TKAs?\n\nFor questions 1 and 2, we hypothesize that robotic-assisted revision or primary TKAs will have improved recovery when compared to manual TKAs.\n\nFor question 3, we hypothesize that robotic-assisted revision TKA will have similar recovery to primary robotic-assisted TKA.\n\nPatients who are candidates for revision or primary TKA will be recruited within the Department of Orthopaedic Surgery. All subjects will participate in 6 evaluation sessions: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery. Testing sessions will be approximately 1 hour long and will take place at the Physical Therapy Clinical and Translational Research Center (PT-CTRC).\n\nAt the time of enrollment, subjects will sign the informed consent in the presence of a study investigator. The research coordinator will collect data on demographics, medical history, and biomedical information. Note: Subjects who do not sign the consent form cannot participate in the study.\n\nAt each evaluation, patients will then be given time to complete the following patient reported outcome questionnaires: Forgotten Joint, Promis 29, Koos, SF 36. The physical therapist will then lead the patient through a series of functional measurement tests: Timed Up and Go (TUG), 4m and 10m walking speed test, sit/stand, Star Excursion Balance Test (SEBT), 2-minute walk, stair climb test (SCT), Single Leg Stance (SLS), and Y Balance Test (YBT). Videos may be taken to record progress.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of patients who are candidates for primary or revision total knee arthroplasty.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Candidate for TKA\n* Speak English / understand study instructions--this is necessary to reliably complete the study questionnaires and understand study instructions which are not validated in other languages\n* Have medical clearance from PCP, PI, or co-Investigator to participate in the study\n* Willing to comply with all study procedures and be available for the duration of the study\n\nExclusion Criteria:\n\n* 2+ falls in the past year\n* Unable to ambulate 100 ft without assistive device or rest period\n* Acute illness\n* Have a history of cardiovascular disease or hypertension not controlled by medication\n* Severe visual impairment\n* Lower-extremity amputation\n* Neurological, muscular, systemic, or connective tissue disorder affecting the function of the lower extremities\n* Pregnant\n* Terminal illness\n* Plans to have another joint replacement during study period\n* Plans to relocate from immediate area during study period'}, 'identificationModule': {'nctId': 'NCT06821269', 'briefTitle': 'Functional Recovery After Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Functional Recovery After Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'STUDY23060125'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Manual Revision TKA', 'description': 'These patients underwent revision TKA done manually', 'interventionNames': ['Procedure: Manual revision total knee arthroplasty']}, {'label': 'Robotic-assisted Revision TKA', 'description': 'These patients underwent revision TKA with robotic-assistance', 'interventionNames': ['Procedure: Robotic assisted revision total knee arthroplasty']}, {'label': 'Manual Primary TKA', 'description': 'These patients received primary TKAs done manually', 'interventionNames': ['Procedure: Manual total knee arthroplasty']}, {'label': 'Robotic-assisted Primary TKA', 'description': 'These patients received primary TKAs with robotic-assistance', 'interventionNames': ['Procedure: Robotic assisted total knee arthroplasty']}], 'interventions': [{'name': 'Robotic assisted total knee arthroplasty', 'type': 'PROCEDURE', 'description': 'Total knee arthroplasty with robotic assisatance', 'armGroupLabels': ['Robotic-assisted Primary TKA']}, {'name': 'Manual total knee arthroplasty', 'type': 'PROCEDURE', 'description': 'Total knee arthroplasty without robotic assistance', 'armGroupLabels': ['Manual Primary TKA']}, {'name': 'Robotic assisted revision total knee arthroplasty', 'type': 'PROCEDURE', 'description': 'Revision total knee arthroplasty with robotic assistance', 'armGroupLabels': ['Robotic-assisted Revision TKA']}, {'name': 'Manual revision total knee arthroplasty', 'type': 'PROCEDURE', 'description': 'Revision total knee arthroplasty without robotic assistance', 'armGroupLabels': ['Manual Revision TKA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kenneth Urish, MD, PhD', 'role': 'CONTACT', 'email': 'urishk2@upmc.edu', 'phone': '412-641-8609'}, {'name': 'Kenneth Urish, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Victoria Wong, BA', 'role': 'CONTACT', 'email': 'wongv@upmc.edu', 'phone': '6503880143'}], 'overallOfficials': [{'name': 'Kenneth Urish, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kenneth Urish', 'investigatorAffiliation': 'University of Pittsburgh'}}}}