Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-25 @ 5:18 PM
Study NCT ID:
NCT06709703
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-29
First Post:
2024-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Kinematic Alignment in Total Knee Arthroplasty - a Double-blind Randomised Controlled Trial Between Robotic and Caliper-based Techniques
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Statistician will be blinded to the intervention'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blind randomized controlled-trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-25', 'studyFirstSubmitDate': '2024-11-25', 'studyFirstSubmitQcDate': '2024-11-25', 'lastUpdatePostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Intra-operative procedures', 'timeFrame': 'At the time of surgery', 'description': 'During surgery, the knee for additional intra-operative procedures to obtain a stable knee replacement will be noted:\n\n* Need for ligamentous release - lateral release, medial release, lateral retinaculum release, posterior cruciate ligament release\n* Need for tibial or femoral recut'}, {'measure': 'Surgical cost', 'timeFrame': 'At the time of surgery', 'description': 'Total cost of implants and equipment used will be calculated at the end of each surgical case.'}, {'measure': 'Surgical time', 'timeFrame': 'At the time of surgery', 'description': 'The time from first incision to skin closure will be noted at each surgery.'}, {'measure': 'Intra-operative complications', 'timeFrame': 'At the time of surgery', 'description': 'The incidence of intra-operative complications will be noted:\n\n* Unplanned ligament injury\n* Neurovascular damage\n* Intra-operative tibial of femoral fracture\n* Any other complications noted during surgery'}], 'primaryOutcomes': [{'measure': 'Radiographic alignment of the knee', 'timeFrame': 'Pre-operative alignement and 6 months post-operative alignement.', 'description': 'Long leg anteroposterior views of both legs and lateral knee radiographs will be used to measure knee alignment and position of the knee replacement hardware. The angles measured and analyzed will be:\n\n* The hip-knee-ankle (HKA) angle\n* Medial proximal tibia mechanical angle (MPTAm)\n* Lateral distal femur mechanical angle (LDTAm)\n* Distal femur flexion angle (DFFA)\n* Posterior tibial slope (PTS) Radiographic measurements will be made by a trained observer and a fellowship-train arthroplasty surgeon.'}, {'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': 'Pre-operative, 6 weeks, 6 months, 12 months, 24 months post-operative', 'description': 'Patient questionnaire (42 questions) evaluating knee pain, symptoms, function, recreational activities and knee-related quality of life. The questionnaire is score over 100 points, with a higher score meaning better knee function.'}, {'measure': 'Forgotten joint score', 'timeFrame': 'Pre-operative, 6 weeks, 6 months, 12 months and 24 months post-op', 'description': 'A 12-questions form asking patients if they forget about their joint during activities of daily living.'}, {'measure': 'Joint perception question', 'timeFrame': 'Pre-operative, 6 weeks, 6 months, 12 months and 24 months post-operative', 'description': 'A single item question asking participants how they perceive their operated knee, from "like a native or natural joint" to "like a nonfunctional joint".'}], 'secondaryOutcomes': [{'measure': 'Pain visual analog scale', 'timeFrame': 'Pre-op, 6 weeks, 6, 12, 24 months', 'description': 'Pain rated on a 10 cm visual analog scale from "no pain" to "worst pain imaginable"'}, {'measure': 'Subjective Assessment Numeric Evaluation Scale (SANE)', 'timeFrame': 'Pre-op, 6 weeks, 6, 12, 24 months', 'description': 'Single question evaluation scale asking the patient to rate their knee function from 0 (no function) to 100 (completely normal function)'}, {'measure': 'Knee range of motion', 'timeFrame': 'Pre, 6 weeks, 6 and 12 months post-op', 'description': 'Maximum passive flexion and extension measured with goniometer'}, {'measure': 'Knee stability', 'timeFrame': 'Pre-op, 6 weeks, 6 and 12 months post-op', 'description': 'Anterior drawer, posterior drawer, valgus stress, varus stress. Instability rated for each test 1 to 3 by treating surgeon.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['osteoarthritis', 'arthritis', 'knee osteoarthritis', 'knee OA', 'knee arthritis', 'total knee replacement', 'robotic', 'kinematic alignment', 'patient-specific surgery'], 'conditions': ['Arthritis', 'Arthritis (Knee)', 'Osteoarthritis', 'Osteoarthritis Knee Pain', 'OA', 'OA Knee', 'OA Knee Pain', 'Osteoarthritis of Knee', 'Gonarthrosis; Primary']}, 'referencesModule': {'references': [{'pmid': '33547914', 'type': 'BACKGROUND', 'citation': 'Zhang J, Ndou WS, Ng N, Gaston P, Simpson PM, Macpherson GJ, Patton JT, Clement ND. Robotic-arm assisted total knee arthroplasty is associated with improved accuracy and patient reported outcomes: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2022 Aug;30(8):2677-2695. doi: 10.1007/s00167-021-06464-4. Epub 2021 Feb 6.'}, {'pmid': '32234326', 'type': 'BACKGROUND', 'citation': 'Agarwal N, To K, McDonnell S, Khan W. Clinical and Radiological Outcomes in Robotic-Assisted Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. J Arthroplasty. 2020 Nov;35(11):3393-3409.e2. doi: 10.1016/j.arth.2020.03.005. Epub 2020 Mar 11.'}, {'pmid': '36403396', 'type': 'BACKGROUND', 'citation': 'Van Essen J, Stevens J, Dowsey MM, Choong PF, Babazadeh S. Kinematic alignment results in clinically similar outcomes to mechanical alignment: Systematic review and meta-analysis. Knee. 2023 Jan;40:24-41. doi: 10.1016/j.knee.2022.11.001. Epub 2022 Nov 17.'}, {'pmid': '24986944', 'type': 'BACKGROUND', 'citation': 'Dossett HG, Estrada NA, Swartz GJ, LeFevre GW, Kwasman BG. A randomised controlled trial of kinematically and mechanically aligned total knee replacements: two-year clinical results. Bone Joint J. 2014 Jul;96-B(7):907-13. doi: 10.1302/0301-620X.96B7.32812.'}, {'pmid': '37165209', 'type': 'BACKGROUND', 'citation': 'Turan K, Camurcu Y, Kezer M, Uysal Y, Kizilay YO, Ucpunar H, Temiz A. A comparison of robotic-assisted and manual techniques in restricted kinematically aligned total knee arthroplasty: coronal alignment improvement with no significant clinical differences. Knee Surg Sports Traumatol Arthrosc. 2023 Nov;31(11):4673-4679. doi: 10.1007/s00167-023-07426-8. Epub 2023 May 10.'}]}, 'descriptionModule': {'briefSummary': 'Knee replacement surgery is a surgery designed to treat severe arthritis of the knee. However, as many as 20% of patients are not satisfied with the results of their surgery. To place the knee replacement in correct position, the kinematic alignment method, which tries to reproduce the patient normal anatomy, has shown promise in improving the satisfaction after knee replacement surgery. It is not known if using a robotic arm to assist in surgery is better than the traditional method when trying to recreate kinematic alignment.\n\nThe goal of this study is to learn if robotic assisted surgery is better than traditional method for knee replacement done using kinematic alignment. The main questions the study tries to answer are:\n\n1. Do the radiographs of kinematic knee replacement surgeries done with robotic assistance show better alignment than radiographs of kinematic knee replacements done with the traditional method?\n2. Does robotic assisted kinematic knee replacement give better function to patients than traditional knee replacement done with kinematic alignment?\n3. Does robotic assisted kinematic knee replacement decrease pain, improve knee movement and improve knee stability better than traditional knee replacement done with kinematic alignment?\n4. Are there more complications with robotic assisted kinematic knee replacement in comparison to traditional kinematic knee replacement?\n5. How long long does it take a surgeon to become good a performing a kinematic knee replacement using robotic assistance? Researchers will compare knee replacements done using a robotic to make the bone cuts, and compare it to the usual method using guides and manual instruments. All the knee replacements will be done using the kinematic alignment and with the same type of knee replacement prothesis.\n\nParticipants will:\n\n* Have a knee replacement done with the kinematic alignment technique by an experienced surgeon, with or without robotic assistance during the surgery.\n* Visit the clinic before surgery, six weeks after surgery, three months, six months, twelve months and twenty-four months after the surgery.\n* Fill questionnaire, have their knee examined and have radiographs of their knee done at each visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient aged 18 or above\n* Patient being consented for a primary total knee arthroplasty (TKA)\n* The primary TKA is planned to be done with kinematic alignment\n* All pre-operative alignments are included\n\nExclusion Criteria:\n\n* Revision TKA (including revision of unicompartimental knee arthroplasty into total knee arthroplasty with primary components). TKA being done in the setting of previous femur or tibia fracture or osteotomy are however included.\n* No available adequate pre-operative imaging\n* Patient who does want to be randomized of the two groups\n* At the discretion of the surgeon, if the patient's pathology or particular anatomy precludes the use of kinematic alignment technique, robotic surgery, or traditional instrument TKA."}, 'identificationModule': {'nctId': 'NCT06709703', 'briefTitle': 'Kinematic Alignment in Total Knee Arthroplasty - a Double-blind Randomised Controlled Trial Between Robotic and Caliper-based Techniques', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': "L'Alignement cinématique Dans Les prothèses de Totales de Genou : un Essai randomisé contrôlé à Double Insu Comparant la Robotique Aux Instruments Traditionnels", 'orgStudyIdInfo': {'id': '2025-958'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Kinematic knee replacement with traditional instruments', 'description': 'Patients will undergo kinematic aligned knee replacement done using traditional instruments and cut guides', 'interventionNames': ['Procedure: Kinematic aligned total knee replacement']}, {'type': 'EXPERIMENTAL', 'label': 'Robotic-assisted kinematic knee replacement', 'description': 'Patients will undergo kinematic aligned knee replacement done using robotic assistance', 'interventionNames': ['Procedure: Kinematic aligned total knee replacement']}], 'interventions': [{'name': 'Kinematic aligned total knee replacement', 'type': 'PROCEDURE', 'description': "Replacement of worn knee cartilage using a prosthesis. The alignment is determined according to the patient's anatomy and ligament balance.", 'armGroupLabels': ['Kinematic knee replacement with traditional instruments', 'Robotic-assisted kinematic knee replacement']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Samuel Larrivée, MD, MSc, FRCSC', 'role': 'CONTACT', 'email': 'samuel.larrivee@usherbrooke.ca', 'phone': '450-466-4333', 'phoneExt': '2'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Anonymous individual patient data will be shared only with a direct request to the study principal investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hopital Charles Lemoyne', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopaedic Surgeon', 'investigatorFullName': 'Samuel Larrivée', 'investigatorAffiliation': 'Université de Sherbrooke'}}}}