Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:19 PM
Study NCT ID:
NCT07367802
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-26
First Post:
2025-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring the Benefits of a 3D Patient-specific Alignment in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-12-27', 'size': 1139112, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2026-01-19T09:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-19', 'studyFirstSubmitDate': '2025-12-15', 'studyFirstSubmitQcDate': '2026-01-19', 'lastUpdatePostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Height', 'timeFrame': '2 years after TKA', 'description': 'Stadiometer; height in millimeters'}, {'measure': 'Joint angles', 'timeFrame': '2 years after surgery', 'description': 'Vicon Nexus 2.12 software (©Vicon Motion Systems Ltd., Oxford, UK); Unit: Degrees'}, {'measure': 'Age', 'timeFrame': '2 years after TKA', 'description': 'year'}, {'measure': 'Leg Length', 'timeFrame': '2 years after TKA', 'description': 'Direct Tape Measure; Leg Length in millimeters'}, {'measure': 'Inter-ASIS Dist', 'timeFrame': '2 years after TKA', 'description': 'Vernier caliper， Inter-ASIS Dist in millimeters'}, {'measure': 'Knee Width', 'timeFrame': '2 years after TKA', 'description': 'Vernier caliper, Knee Width in millimeters'}, {'measure': 'Ankle Width', 'timeFrame': '2 years after TKA', 'description': 'Vernier caliper, Ankle Width in millimeters'}, {'measure': 'Elbow Width', 'timeFrame': '2 years after TKA', 'description': 'Vernier caliper, Elbow Width in millimeters'}, {'measure': 'Wrist Width', 'timeFrame': '2 years after TKA', 'description': 'Vernier caliper, Wrist Width in millimeters'}, {'measure': 'Hand Thickness', 'timeFrame': '2 years after TKA', 'description': 'Vernier caliper, Hand Thickness in millimeters'}, {'measure': 'Total Gait Cycle Duration', 'timeFrame': '2 years after TKA', 'description': 'Vicon Nexus 2.12 software (©Vicon Motion Systems Ltd., Oxford, UK); Unit in second'}, {'measure': 'Visual Analog Scale', 'timeFrame': 'Pre-TKA, 6 weeks after TKA, 2 years after TKA', 'description': 'Pain Scores'}, {'measure': 'Oxford Knee Score (OKS)', 'timeFrame': 'Pre-TKA; 2 years after TKA', 'description': 'total score ranging from 0 to 48'}, {'measure': 'maximum voluntary isometric strength tests of the lower limb', 'timeFrame': '2 years after TKA', 'description': 'Peak force measured with a hand-held dynamometer (Micro FET 2 Handheld Dynamometer, Hoggan, USA); Unit: Newtons'}, {'measure': 'Muscle activity patterns for eight muscles (gluteus medius, rectus femoris, vastus medialis, vastus lateralis, biceps femoris, semitendinosus, tibialis anterior and gastrocnemius medialis)', 'timeFrame': '2 years after TKA', 'description': 'A 16-channel telemetric wireless surface electromyography (EMG) system (Waveplus®, Cometa, Rome, Italy) operating at 1000 Hz was utilized. Unit: Volt'}], 'secondaryOutcomes': [{'measure': 'BMI', 'timeFrame': '2 years after TKA', 'description': 'weight and height will be combined to report BMI in kg/m2'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TKA', 'iKA', 'aMA'], 'conditions': ['TKA Outcomes']}, 'referencesModule': {'references': [{'pmid': '35513224', 'type': 'RESULT', 'citation': 'Winnock de Grave P, Kellens J, Luyckx T, Tampere T, Lacaze F, Claeys K. Inverse Kinematic Alignment for Total Knee Arthroplasty. Orthop Traumatol Surg Res. 2022 Sep;108(5):103305. doi: 10.1016/j.otsr.2022.103305. Epub 2022 May 2.'}]}, 'descriptionModule': {'briefSummary': 'General Aim: to explore the iKA in TKA related to clinical, biomechanical, and functional outcomes.', 'detailedDescription': 'First specific aim: to investigate the kinematics during daily functional movements in individuals with the iKA TKA to those with aMA TKA, as well as the healthy control group.\n\nSecond specific aim: to investigate kinetics and muscle activation patterns during functional movements in individuals with the iKA aligned TKA to those with aMA TKA, as well as a healthy control group.\n\nThird specific aim: to investigate the impact of the whole body on functional outcomes following iKA and aMA TKA, in comparison to the healthy control group, and to explore the underlying factors contributing to suboptimal outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nwere age under 85 years. primary robot-assisted TKA using either iKA or aMA. surgery performed two years before enrollment. independent ambulation without assistive devices; and informed consent.\n\nExclusion Criteria:\n\nhistory of lower limb trauma or fracture. neurological disorders (e.g., stroke, Parkinson's disease, multiple sclerosis). systemic musculoskeletal diseases (e.g., rheumatoid arthritis, diabetic neuropathy).\n\nrevision arthroplasty. and cognitive impairment affecting study participation."}, 'identificationModule': {'nctId': 'NCT07367802', 'acronym': 'iKA', 'briefTitle': 'Exploring the Benefits of a 3D Patient-specific Alignment in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Exploring the Benefits of a 3D Patient-specific Alignment in Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'S67874'}, 'secondaryIdInfos': [{'id': 'B3222022001251', 'type': 'OTHER', 'domain': 'Ethics Committee Research UZ/KU Leuven'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'To examine the lower limb kinematic differences during the challenging daily functional movements, s', 'description': 'To examine the lower limb kinematic differences during the challenging daily functional movements, such as the lunge, in individuals who have undergone iKA TKA, compared to those with aMA TKA and healthy controls.', 'interventionNames': ['Procedure: iKA']}], 'interventions': [{'name': 'iKA', 'type': 'PROCEDURE', 'description': 'This study compared inverse kinematic alignment (iKA) TKA, which preserves native JLO, with adjusted mechanical alignment (aMA) TKA, which standardizes JLO to 90°, and a healthy control group across eight functional activities.', 'armGroupLabels': ['To examine the lower limb kinematic differences during the challenging daily functional movements, s']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Bruges', 'state': 'West', 'country': 'Belgium', 'facility': 'KULeuven', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'it is a 15 year study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'KUleuven Brugge', 'investigatorFullName': 'zhijun li', 'investigatorAffiliation': 'KU Leuven'}}}}