Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT06061367
Status:
UNKNOWN
Last Update Posted:
2023-10-30
First Post:
2023-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Muscles Strength and Gait Parameteres After TKA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-26', 'studyFirstSubmitDate': '2023-07-29', 'studyFirstSubmitQcDate': '2023-09-24', 'lastUpdatePostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle strength measurement with a use of dynamometer', 'timeFrame': '6 months', 'description': 'Analysis of pre- and postoperative strength of lower limb muscles. Assessment of force \\[N\\] generated by knee flexors, knee extensors, hip adductors and hip abductors with a use of a hand-held dynamometer.'}, {'measure': 'Gait biomechanics analysis - step length', 'timeFrame': '6 months', 'description': 'Analysis of pre- and postoperative parameters of gait pattern and biomechanics with a use of Baiobit device (wearable motion analysis system). Subjected to the analysis will be the step length (in meters).'}, {'measure': 'Gait biomechanics analysis - gait speed', 'timeFrame': '6 months', 'description': 'Analysis of pre- and postoperative parameters of gait pattern and biomechanics with a use of Baiobit device (wearable motion analysis system). Subjected to the analysis will be the gait speed (metre per second).'}, {'measure': 'Gait biomechanics analysis - phases of gait', 'timeFrame': '6 months', 'description': 'Analysis of pre- and postoperative parameters of gait pattern and biomechanics with a use of Baiobit device (wearable motion analysis system). Subjected to the analysis will be the swing and the stance phase of gait (% of the gait cycle).'}, {'measure': 'Gait biomechanics analysis - step duration', 'timeFrame': '6 months', 'description': 'Analysis of pre- and postoperative parameters of gait pattern and biomechanics with a use of Baiobit device (wearable motion analysis system). Subjected to the analysis will be the duration of left and right step (in seconds).'}, {'measure': 'Physical function assessment based on standardized test', 'timeFrame': '6 months', 'description': 'Analysis of pre- and postoperative physical function on the basis of Up and Go test.'}], 'secondaryOutcomes': [{'measure': 'Patient-reported outcome - Oxford Knee Score', 'timeFrame': '6 months', 'description': 'Pre- and postoperative evaluation of Oxford Knee Score. Patients will be asked 12 closed-end questions. 5 possible answers to choose. The scoring system is from 0 to 4 for each answer. Total score ranges from 0 to 48, where 0 is the poorest outcome, and 48 is the best one.'}, {'measure': 'Patient-reported outcome - Forgotten Joint Score', 'timeFrame': '6 months', 'description': 'Pre- and postoperative evaluation of Forgotten Joint Score. The questionnaire is based on 12 questions. Total score ranges from 0 to 100. Higher score on the questionnaire, means better results were obtained.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthritis Knee', 'Gait Biomechanics', 'Total Knee Arthroplasty', 'Muscle Strength', 'Osteoarthritis']}, 'descriptionModule': {'briefSummary': "Total Knee Arthroplasty (TKA) is actually the most effective treatment option for patients with end-stage osteoarthritis (OA). However, nearly 20% of patients who underwent TKA remain unsatisfied with their clinical outcome. Investigating modifiable factors that limit knee functioning following TKA we may notice the significance of lower limb muscles strength. Gait pattern is also affected by OA, as arthritic knee joint cannot provide proper range of motion (ROM) and stability.Therefore any deviation in biomechanics should be noticed and analyzed. After TKA patients' physical function may change, but the study should be conducted to prove whether it improves or not. Patient-reported outcome defined by OKS (Oxford Knee Score) and FJS (Forgotten Joint Score) questionnaires will be evaluated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over 50 years old with knee osteoarthritis', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* III° or IV° grade knee osteoarthritis\n* Age over 50\n* Patients with signed consent\n\nExclusion Criteria:\n\n* Undergone total hip replacement\n* Previous femur fracture in anamnesis\n* Undergone corrective osteotomy\n* Active/ Chronic neoplastic disease\n* Significant deformation of lower limb axis\n* Mental disorders\n* Muscular disorders'}, 'identificationModule': {'nctId': 'NCT06061367', 'briefTitle': 'Muscles Strength and Gait Parameteres After TKA', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Influence of Lower Extremity Muscles Strength on Physical Function, Biomechanical Gait Parameters and Reported Outcome After Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'WarsawMU/MUSABGP'}}, 'contactsLocationsModule': {'locations': [{'zip': '04-749', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Marcin Łapiński, MD', 'role': 'CONTACT', 'email': 'marcin.lapinski@wum.edu.pl', 'phone': '664011943', 'phoneExt': '+48'}], 'facility': 'Department of Orthopedics and Rehabilitation, Medical University of Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Artur Stolarczyk', 'investigatorAffiliation': 'Medical University of Warsaw'}}}}