Меню
Набор скоро начнётся NCT06835621

Comparison of Functional Recovery Between Restricted Inverse Kinematic Alignment and Adjusted Mechanical Alignment With Robotic-assisted Unilateral Total Knee Arthroplasty.

Без фазы С лечением OA Knee TKA

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Restricted inverse kinematic alignment Total Knee Arthroplasty, Adjusted Mechanical alignment Total Knee Arthroplasty.
Кому может быть актуально
Состояния в реестре: OA Knee, TKA. Базовые параметры: 50 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Таиланд
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Comparison of Functional Recovery Between Restricted Inverse Kinematic Alignment and Adjusted Mechanical Alignment With Robotic-assisted Unilateral Total Knee Arthroplasty. A Randomized Controlled Trial.

Обзор

The goal of this clinical trial is to learn if restricted inverse kinematic alignment total knee arthroplasty (restricted iKA TKA) improves functional recovery compared to adjusted mechanical alignment total knee arthroplasty (aMA TKA) in patients undergoing unilateral robotic-assisted total knee arthroplasty by comparing performance-based outcome, 2-minute walk test (2MWT) as a primary outcome. This trial will also assess other outcomes including satisfaction, patient-reported functional outcomes, range of motion, visual analog scale for pain and complication of both techniques. The main question aims to answer is: In unilateral robotic-assisted total knee arthroplasty, dose Restricted iKA technique provide better postoperative performance-based outcome compared to aMA technique? Researchers will compare restricted iKA and aMA technique to determine which technique offers better acceleration in functional recovery and patient satisfaction. Participants will: After randomization, participants will allocate to either restricted iKA or aMA technique for unilateral robotic-assisted total knee arthroplasty. Attend follow-up visits for assessments of 2-minute walk test (Primary outcome), Time up and go test (TUG), VAS for pain, ROM and complete patient-reported functional outcome questionnaires regarding knee function and satisfaction at regular intervals.

Подробное описание

Nowadays, total knee arthroplasty (TKA) for the treatment of osteoarthritis patients generally aims to achieve a neutral alignment of the leg. This involves cutting the bones perpendicular to the mechanical axis in both the femur and tibia. This method is called mechanical alignment TKA (MA TKA), which is widely popular and is often considered the standard technique for TKA. It has shown satisfactory long-term outcomes. However, despite advancements in materials and surgical techniques, MA TKA still requires bone and soft tissue adjustments to correct alignment, which may involve releasing soft tissues. This can result in post-surgical pain or dissatisfaction, with up to 20% of patients reporting dissatisfaction despite improved knee pain compared to pre-surgery. Furthermore, 1 in 4 of these dissatisfied patients do not wish to undergo a revision surgery, as the MA TKA method is a "one-size-fits-all" approach that aims to achieve equal and parallel gaps between the femur and tibia components without respecting individual soft tissue balance and the original alignment of each patient's leg. However, adjusted mechanical alignment technique, an adaptation of conventional MA technique with under-correction of constitutional coronal deformity, within a limit of ± 3° (HKA -3° to 3) has been introduced according to the constitutional deformity and coronal plan alignment of the knee concept.

In 2006, Howell introduced kinematic alignment TKA (KA TKA) as an alternative, with the goal of restoring the patient's natural kinematic axis and reducing the incidence of pain related to TKA rather than focusing on equal medial and lateral joint line gap and neutral mechanical axis like in mechanical alignment technique. KA TKA is considered a more personalized approach because it aims to replicate the knee's pre-arthritic alignment and movement, believing that each patient's knee has a unique alignment. This approach has gained increasing interest in recent years, with studies reporting good short- to mid-term clinical outcomes. However, the KA technique is more complex because we cannot always know the pre-arthritic alignment of individual patients and measuring soft tissue tension remains imprecise.

Later, Dr. Pascal-André Vendittoli proposed the restricted kinematic alignment TKA (rKA TKA) technique to restore natural knee movement while avoiding excessive correction of coronal alignment by maintain the HKA axis within ± 3 degrees (safe zone). By maintaining some of the constitutional deformity, this technique reduces the need for excessive soft tissue or ligament releases. In 2020 Winnock et al, introduced the Inversed kinematic technique (iKA) or tibia-referenced technique by resurfacing the tibia with equal medial and lateral resections maintaining the native tibial joint line obliquity before distal femoral bone. When combines these KA principles with robotic-assisted TKA, enhancing the accuracy of soft tissue balancing and the overall effectiveness of the procedure.

In 2020, McEwen et al. compared the use of robotic-assisted KA with MA in the same patients who underwent bilateral knee surgery using different techniques. They found that clinical outcomes, including range of motion and knee scores, were not significantly different at any time point. However, Elbuluk conducted a similar comparison, specifically robotic-assisted (MAKO) KA versus MA, and found that the KA group had less pain and better knee scores, including a higher Forgotten Joint Score. Later, Abhari conducted a study comparing robotic-assisted (MAKO) restricted KA with non-robotic MA TKA and found that the robotic-assisted (MAKO) restricted KA group had superior clinical outcomes and knee scores, including the Forgotten Joint Score, KOOS, WOMAC, Knee Society Score, as well as greater patient satisfaction. However, there are still limited prospective RCTs that study differences in outcomes, especially performance-based outcomes between restricted inverse kinematic alignment (restricted iKA) versus adjusted mechanical alignment (aMA). Therefore, the researchers aim to conduct a study comparing the efficiency of performance-based outcomes as a primary focus, including patient-reported outcome questionnaires, ROM, VAS for postoperative pain, postoperative morphine consumption within 24 hours, postoperative lower limb alignment (HKA axis), operative time, blood loss, and complications. The goal is to further advance the development of knee replacement surgery.

Вмешательства

  • Процедура Restricted inverse kinematic alignment Total Knee Arthroplasty
    Restricted inverse kinematic alignment (restricted iKA) total knee arthroplasty is an alignment technique of total knee replacement surgery, aim to maintain the native coronal alignment within a HKA angle safe zone of 177° to 183°. This technique aims to 'resurface' the femur maintaining the native femoral joint line obliquity, with the flexion and extension gaps balanced by adjusting the tibial resection first. It is considered a more personalized approach because it aims to replicate the knee'
  • Процедура Adjusted Mechanical alignment Total Knee Arthroplasty
    The adjusted Mechanical Alignment (aMA) technique is an adaptation of the conventional MA technique but with undercorrection of constitutional coronal deformity, within a limit of ± 3°. The femoral resection is adjusted to preserve mild constitutional deformity and/or reduce more severe deformity while leaving the tibial component mechanically aligned. The tibial component was positioned with the aim to be perpendicular (90°) to the mechanical tibial axis.

Первичные конечные точки

  • 2-minute walk test [Срок оценки: From enrollment (preoperative measurement) to the end of postoperative follow-up (2 years)]
Вторичные конечные точки (12)
  • Time up and go test [Срок оценки: From enrollment (preoperative measurement) to the end of postoperative follow-up (2 years)]
  • modified WOMAC scale for knee pain (Thai version) [Срок оценки: From enrollment (preoperative measurement) to the end of postoperative follow-up (2 years)]
  • Thai version of the Forgotten Joint Score [Срок оценки: From enrollment (preoperative measurement) to the end of postoperative follow-up (2 years)]
  • Oxford knee score [Срок оценки: From enrollment (preoperative measurement) to the end of postoperative follow-up (2 years)]
  • Range of Motion [Срок оценки: From enrollment (preoperative measurement) to the end of postoperative follow-up (2 years)]
  • Hip knee ankle angle [Срок оценки: From enrollment (preoperative measurement) and at 1-year postoperative follow-up.]
  • Visual analog scale for Pain [Срок оценки: From enrollment (preoperative measurement) to the end of postoperative follow-up (2 years)]
  • Morphine consumption [Срок оценки: Postoperative interval of 24-72 hours]
  • Complication [Срок оценки: After surgery and up to 2 years]
  • Medial proximal tibial angle (MPTA) [Срок оценки: From enrollment (preoperative measurement) and at 1-year postoperative follow-up.]
  • Lateral distal femoral angle (LDFA) [Срок оценки: From enrollment (preoperative measurement) and at 1-year postoperative follow-up.]
  • Joint line obliquity (JLO) [Срок оценки: From enrollment (preoperative measurement) and at 1-year postoperative follow-up.]

Критерии участия

Критерии включения

  • Age 50 - 80 years old
  • Diagnosed with primary OA knee and indicated for unilateral total knee arthroplasty with MAKO robotic-assisted knee replacement system
  • ASA classification I-II

Критерии исключения

  • Valgus deformity
  • KL grading > 3 on contralateral knee
  • Unable or difficulty for walking due to comorbidities
  • BMI > 40 kg/m2
  • Previous knee surgery
  • Infection around the knee

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Таиланд · 2 центра
  • Faculty of Medicine, Thammasat University — Klongluang
  • Faculty of Medicine, Thammasat University — Klongluang

Публикации

  • Elbuluk AM, Jerabek SA, Suhardi VJ, Sculco PK, Ast MP, Vigdorchik JM. Head-to-Head Comparison of Kinematic Alignment Versus Mechanical Alignment for Total Knee Arthroplasty. J Arthroplasty. 2022 Aug;37(8S):S849-S851. doi: 10.1016/j.arth.2022.01.052. Epub 2022 Jan 31. PMID 35093548
  • McEwen PJ, Dlaska CE, Jovanovic IA, Doma K, Brandon BJ. Computer-Assisted Kinematic and Mechanical Axis Total Knee Arthroplasty: A Prospective Randomized Controlled Trial of Bilateral Simultaneous Surgery. J Arthroplasty. 2020 Feb;35(2):443-450. doi: 10.1016/j.arth.2019.08.064. Epub 2019 Sep 5. PMID 31591010
  • 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
  • Blakeney WG, Vendittoli PA. Restricted Kinematic Alignment: The Ideal Compromise? 2020 Jul 1. In: Riviere C, Vendittoli PA, editors. Personalized Hip and Knee Joint Replacement [Internet]. Cham (CH): Springer; 2020. Chapter 17. Available from http://www.ncbi.nlm.nih.gov/books/NBK565760/ PMID 33347126
  • Howell SM, Shelton TJ, Hull ML. Implant Survival and Function Ten Years After Kinematically Aligned Total Knee Arthroplasty. J Arthroplasty. 2018 Dec;33(12):3678-3684. doi: 10.1016/j.arth.2018.07.020. Epub 2018 Jul 31. PMID 30122435
  • Vanlommel L, Vanlommel J, Claes S, Bellemans J. Slight undercorrection following total knee arthroplasty results in superior clinical outcomes in varus knees. Knee Surg Sports Traumatol Arthrosc. 2013 Oct;21(10):2325-30. doi: 10.1007/s00167-013-2481-4. Epub 2013 Apr 4. PMID 23552665
  • Winnock de Grave P, Luyckx T, Claeys K, Tampere T, Kellens J, Muller J, Gunst P. Higher satisfaction after total knee arthroplasty using restricted inverse kinematic alignment compared to adjusted mechanical alignment. Knee Surg Sports Traumatol Arthrosc. 2022 Feb;30(2):488-499. doi: 10.1007/s00167-020-06165-4. Epub 2020 Jul 31. PMID 32737528
  • Yang Y, Wang Y, Chen Y, Wang J, Lu B, Zhu W, Zhu J, Zhu C, Zhang X. Tracing the evolution of robotic-assisted total knee arthroplasty: a bibliometric analysis of the top 100 highly cited articles. J Robot Surg. 2023 Dec;17(6):2973-2985. doi: 10.1007/s11701-023-01742-4. Epub 2023 Oct 26. PMID 37882976

Идентификаторы

NCT: NCT06835621 · MTU-EC-OT-0-240/67

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗