Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-02-22 @ 3:57 PM
Study NCT ID:
NCT06259032
Status:
COMPLETED
Last Update Posted:
2024-11-21
First Post:
2024-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effect of Mechanical and Functional Alignment in Bilateral Total Knee Arthroplasty on Ankle Alignment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2024-01-26', 'studyFirstSubmitQcDate': '2024-02-06', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Other outcomes : soft tissue release', 'timeFrame': 'intraoperative', 'description': 'intra-operative soft tissue release (medial collateral ligament release or others structure around knee) report with Yes (soft tissue release) or No (no soft tissue release)'}, {'measure': 'Other outcomes : operative time', 'timeFrame': 'intraoperative', 'description': 'measured in minutes from skin incision to complete of skin suture'}, {'measure': 'Other outcomes : blood loss', 'timeFrame': 'post operative with in 2 days', 'description': 'record in millilitre measured from Radivac drain'}, {'measure': 'Other outcomes : pain score (Visual analog scale)', 'timeFrame': 'post-operative at 2,4,8,12 weeks', 'description': 'score from 0-10 (0 was no pain, 10 was worst pain )'}, {'measure': 'Other outcomes : Range of knee motion', 'timeFrame': 'post-operative at 2,4,8,12 weeks', 'description': 'record in total degree of knee motion'}, {'measure': 'complications', 'timeFrame': 'post-operative at 2,4,8,12 weeks', 'description': 'Yes (complications) or No ( no complications) if yes, will specified the complications complication such as bone fracture, wound dehiscence, surgical site infection, periprosthetic infection ,pulmonary embolism or other adverse outcomes that may or may not directly associated with the operation.'}], 'primaryOutcomes': [{'measure': 'Radiographic outcomes : Hip-knee-ankle angle', 'timeFrame': 'pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks', 'description': 'angle in degree between line from center of head of Femur to intercondylar notch and line from tibial interspinous to center of tibial plafond'}, {'measure': 'Radiographic outcomes : Tibial plafond inclination', 'timeFrame': 'pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks', 'description': 'angle in degree between subchondral plate of distal tibial articular surface and vertical axis'}, {'measure': 'Radiographic outcomes :Talar inclination', 'timeFrame': 'pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks', 'description': 'angle in degree between talar dome and vertical axis'}, {'measure': 'Radiographic outcomes : Tibiotalar tilt angle', 'timeFrame': 'pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks', 'description': 'angle in degree between subchondral plate of distal tibial articular surface and talar dome'}], 'secondaryOutcomes': [{'measure': 'Clinical outcomes : Knee injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': 'pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks', 'description': 'a questionnaire assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.'}, {'measure': 'Clinical outcomes : American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score', 'timeFrame': 'pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks', 'description': 'evaluation of the clinical status of the ankle-hindfoot, both subjective and objective information. Patients report their pain, and physicians assess alignment. The patient and physician work together to complete the functional portion. Scores range from 0 to 100, with healthy ankles receiving 100 points.'}, {'measure': 'Quality of Life score : EQ-5D-5L', 'timeFrame': 'pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks', 'description': 'assess patient five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels, Index scores range from -0.42 to 1; 1 is the best possible health state. Negative values represent health states perceived as worse than dead, which is equal to 0.'}, {'measure': 'Forgotten Joint Score', 'timeFrame': 'pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks', 'description': 'consists of 12 questions and is transform on a 0-100 scale.The higher the score, the less the patient is aware of their affected joint when performing daily activities'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthropathy of Knee']}, 'descriptionModule': {'briefSummary': 'Mechanical alignment (MA) in total knee arthroplasty (TKA) is the most commonly used with well-documented long-term results, however 20% of patients express dissatisfaction following primary TKA. Alternative alignment philosophies have been proposed, aiming to improve patient clinical outcomes and satisfaction. However, evaluation is focused mainly on knee alignment, the pathological findings and other adaptational changes in the ankles and hips are usually neglected.\n\nThia study aim to comparative effect between mechanical and functional alignment in patient undergone bilateral robotic TKA on ankle alignment and functional outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20-80 years\n* Symptomatic bilateral knee Osteoarthritis requiring primary TKA\n* Willing to undergo bilateral simultaneous TKA\n* Able to give informed consent\n\nExclusion Criteria:\n\n* ligament deficiency requiring constrained prosthesis\n* bone loss with augmentation need\n* history of fracture around knee or previous osteotomy\n* history of ankle fracture\n* patient with neuromuscular disorder or movement disorder\n* patient is unable to attend the study follow-up program'}, 'identificationModule': {'nctId': 'NCT06259032', 'briefTitle': 'Comparative Effect of Mechanical and Functional Alignment in Bilateral Total Knee Arthroplasty on Ankle Alignment', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Department of Medical Services Ministry of Public Health of Thailand'}, 'officialTitle': 'Comparative Effect of Mechanical and Functional Alignment in Bilateral Total Knee Arthroplasty on Ankle Alignment : a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '66156'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mechanical alignment', 'interventionNames': ['Other: Mechanical alignment']}, {'type': 'EXPERIMENTAL', 'label': 'Functional alignment', 'interventionNames': ['Other: Functional alignment']}], 'interventions': [{'name': 'Mechanical alignment', 'type': 'OTHER', 'description': 'Goal alignment in TKA with mechanical alignment, resection bone in perpendicular to mechanical axis of femur and tibia.', 'armGroupLabels': ['Mechanical alignment']}, {'name': 'Functional alignment', 'type': 'OTHER', 'description': 'Goal alignment in TKA with functional alignment, resection of bone base on native joint line obliquity.', 'armGroupLabels': ['Functional alignment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Ratchathewi', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Rajavithi Hospital', 'geoPoint': {'lat': 13.759, 'lon': 100.53358}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Department of Medical Services Ministry of Public Health of Thailand', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}