Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 11:31 PM
Study NCT ID:
NCT06829433
Status:
RECRUITING
Last Update Posted:
2025-02-21
First Post:
2025-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Movement Dynamics of Knee Osteoarthritis and Total Knee Replacement
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2025-01-28', 'studyFirstSubmitQcDate': '2025-02-10', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak knee adduction moment', 'timeFrame': 'From the start of a biomechanical movement testing visit to the end (approximately 2 hours)', 'description': 'The external knee adduction moment (KAM), which reflects medial-to-lateral knee joint load distribution during gait, has become an OA treatment target. The peak KAM is a strong predictor of presence, severity, and the rate of progression of knee OA.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis', 'Total Knee Replacement']}, 'descriptionModule': {'briefSummary': 'This research aims to explore differences in walking and functional movement mechanics, exercise response, and physical activity between people with osteoarthritis (OA), those who have undergone total joint replacement, and healthy individuals.', 'detailedDescription': "People living with OA tend to be less physically active than those without the disease, which is often due to pain, stiffness and joint instability. This reduction in physical activity can lead to additional health problems down the line. When the disease becomes severe, joint replacement surgeries are sometimes performed to relieve pain and improve individuals' quality of life. However, despite reducing pain, there is little evidence to show that joint replacement surgeries encourage individuals to return to healthy physical activity levels.\n\nReasons for the lack of change may include a failure to address unhealthy walking and movement patterns which could still be causing pain and instability and reduced physical fitness levels.\n\nBy investigating these reasons, we hope that findings from this study will help to inform future interventions that improve clinical outcomes and quality of life for individuals with OA and post-joint replacement."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Local private physiotherapy clinics and local sports clubs', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed symptomatic bilateral or unilateral knee osteoarthritis, self-reported ability to walk without an aid for 10 minutes and to ascend and descend stairs, no neurological conditions or other musculoskeletal pathology/injury which would impact walking gait.\n\nExclusion Criteria:\n\n* Unable to walk at 0.8 m/s, exclusion based on IMO screening, non-English speaking, lacking ability to consent.'}, 'identificationModule': {'nctId': 'NCT06829433', 'acronym': 'MDOA&TKR', 'briefTitle': 'Movement Dynamics of Knee Osteoarthritis and Total Knee Replacement', 'organization': {'class': 'OTHER', 'fullName': 'University of Portsmouth'}, 'officialTitle': 'Quantifying the Movement Dynamics of Adults Living With Total Knee Arthroplasty and Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'SHFEC 2024-007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Total Knee Replacement', 'interventionNames': ['Other: No intervention']}, {'label': 'Knee Osteoarthritis', 'interventionNames': ['Other: No intervention']}, {'label': 'Asymptomatic Controls', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'Observational cross-sectional study', 'armGroupLabels': ['Asymptomatic Controls', 'Knee Osteoarthritis', 'Total Knee Replacement']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PO1 2ER', 'city': 'Portsmouth', 'state': 'Hampshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Josie Morris, Bsc', 'role': 'CONTACT', 'email': 'josie.morris@port.ac.uk', 'phone': '02392 846395'}, {'name': 'Josie Morris, BSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'School of Psychology, Health and Sport Sciences, University of Portsmouth', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}], 'centralContacts': [{'name': 'Josie Morris, BSc', 'role': 'CONTACT', 'email': 'josie.morris@port.ac.uk', 'phone': '02392 846395'}, {'name': 'Joseph Moore, PhD', 'role': 'CONTACT', 'email': 'joseph.moore@port.ac.uk'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Portsmouth', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Josie Morris', 'investigatorAffiliation': 'University of Portsmouth'}}}}