Kinematic Alignment in Total Knee Arthroplasty - a Double-blind Randomised Controlled Trial Between Robotic and Caliper-based Techniques

Официальное название

L'Alignement cinématique Dans Les prothèses de Totales de Genou : un Essai randomisé contrôlé à Double Insu Comparant la Robotique Aux Instruments Traditionnels

Обзор

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. The 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: 1. 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? 2. Does robotic assisted kinematic knee replacement give better function to patients than traditional knee replacement done with kinematic alignment? 3. Does robotic assisted kinematic knee replacement decrease pain, improve knee movement and improve knee stability better than traditional knee replacement done with kinematic alignment? 4. Are there more complications with robotic assisted kinematic knee replacement in comparison to traditional kinematic knee replacement? 5. 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. Participants will: * Have a knee replacement done with the kinematic alignment technique by an experienced surgeon, with or without robotic assistance during the surgery. * Visit the clinic before surgery, six weeks after surgery, three months, six months, twelve months and twenty-four months after the surgery. * Fill questionnaire, have their knee examined and have radiographs of their knee done at each visit.

Вмешательства

• Процедура Kinematic aligned total knee replacement
  Replacement of worn knee cartilage using a prosthesis. The alignment is determined according to the patient's anatomy and ligament balance.

Первичные конечные точки

• Radiographic alignment of the knee [Срок оценки: Pre-operative alignement and 6 months post-operative alignement.]
• Knee Injury and Osteoarthritis Outcome Score (KOOS) [Срок оценки: Pre-operative, 6 weeks, 6 months, 12 months, 24 months post-operative]
• Forgotten joint score [Срок оценки: Pre-operative, 6 weeks, 6 months, 12 months and 24 months post-op]
• Joint perception question [Срок оценки: Pre-operative, 6 weeks, 6 months, 12 months and 24 months post-operative]

Вторичные конечные точки (4)

• Pain visual analog scale [Срок оценки: Pre-op, 6 weeks, 6, 12, 24 months]
• Subjective Assessment Numeric Evaluation Scale (SANE) [Срок оценки: Pre-op, 6 weeks, 6, 12, 24 months]
• Knee range of motion [Срок оценки: Pre, 6 weeks, 6 and 12 months post-op]
• Knee stability [Срок оценки: Pre-op, 6 weeks, 6 and 12 months post-op]

Критерии участия

Критерии включения

• Patient aged 18 or above
• Patient being consented for a primary total knee arthroplasty (TKA)
• The primary TKA is planned to be done with kinematic alignment
• All pre-operative alignments are included

Критерии исключения

• 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.
• No available adequate pre-operative imaging
• Patient who does want to be randomized of the two groups
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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 33547914
• 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 32234326
• 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 36403396
• 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 24986944
• 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. PMID 37165209

Идентификаторы

NCT: NCT06709703 · 2025-958

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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