Robotic-assisted (MAKO) Versus Manual Total Knee Arthroplasty for Knee Osteoarthritis

Официальное название

Single-center, Randomized, Controlled, Double Blinded, 24-month Trial to Compare Robotic-assisted (MAKO) and Manual Total Knee Arthroplasty for Primary Osteoarthritis With 10 Year Follow-up for Complications

Обзор

Background: Total knee arthroplasty is a golden standard procedure for end-stage knee osteoarthritis. However, up to 20% of the patients are not satisfied with the outcome. Recently, robotic-assisted TKAs have been developed to offer individual alignment and to achieve accuracy in positioning with more subtle soft-tissue handling, thus possibly leading into better outcome. Hypothesis: The investigators hypnotize that, robotic-assisted TKA is superior to manual TKA for end-stage osteoarthritis in respect to functional outcome, short-term rehabilitation and cost-efficiency. Trial desing: The investigators will conduct a single-center, randomized, controlled, double blinded superiority trial of 24-months to compare robotic-assisted and manual total knee arthroplasty in respect to functional outcome, implant positioning, short-term rehabilitation and cost-efficiency with up to 10 years follow-up for complications. The principle outcome measure will be patient reported outcome measure (PROM) Oxford knee score (OKS) points (0-48 points) at two years after surgery. Minimal clinically important difference will be considered as 5 points. Other PROMS, patient satisfaction, short-term rehabilitation, implant positioning, knee range of motion, length of sick leave and cost efficiency will also be reported. Patients will be followed up to 10 years for complications (infection, manipulation and revisions). This study will be conducted in Central Hospital of Satakunta (Satasairaala), Finland. The investigators will recruit 170 adult patients (aged 50-80), with end-stage (Kellgren-Lawrence grade IV) primary osteoarhritis. Patients will be randomly assingned to either robotic-assisted or manual TKA. Patients will be blinded by the intervention method used. Personnel and investigators assessing the patients and interpreting the data will also be blinded to the surgical method.

Вмешательства

• Устройство Robotic-assisted total knee arthroplasty
  In robotic-assisted total knee arthroplasty, the procedure is performed with the guidance of the robot according to CT-based plan.
• Процедура Manual total knee arthroplasty
  In manual total knee arthroplasty, the procedure is performed with jig guides according to whole leg weight bearing x-ray planning.

Первичные конечные точки

• Oxford Knee score OKS at 24 months [Срок оценки: 24 month]

Вторичные конечные точки (12)

• Oxford Knee Score at 3 and 12 months [Срок оценки: 3 and 12 months visits]
• Knee injury and Osteoarthritis Outcome Score (KOOS) at 3, 12 and 24 months [Срок оценки: 3, 12 and 24 months]
• The Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 3, 12 and 24 months. [Срок оценки: 3, 12 and 24 months]
• Patient satisfaction inquiry at 3, 12 and 24 months [Срок оценки: 3, 12 and 24 months]
• Working ability, lenght of the sick leave [Срок оценки: up to 24 months]
• Working ability, part-time vs full-time [Срок оценки: Asked at 3 month, 12 months and 24 months after the surgery]
• Working ability, physical demands of the job [Срок оценки: Asked at 3 month, 12 months and 24 months after the surgery]
• Life quality questionnaire 15 dimensions (15D) at 3, 12 and 24 months [Срок оценки: 3, 12 and 24 months]
• Pain at rest and during walking on visual analoque scale (VAS) [Срок оценки: First day after the operation and at 3, 12 and 24 months]
• Opioid usage [Срок оценки: Up to two weeks]
• Blood loss [Срок оценки: First day after the operation]
• Lenght of the hospital stay [Срок оценки: Up to 1 week]

Критерии участия

Критерии включения

• Age over 50 and below 80 years
• End-stage Kellgren-Lawrence grade IV KOA
• Failed conservative treatment

Критерии исключения

• Post-traumatic knee osteoarthritis
• Rheumatoid arthritis
• Previous knee infections
• Previous knee surgery (other than diagnostic arthroscopy or meniscectomy)
• Knee range of motion within 15 to 100 degrees
• Mechanical axis over 15 degrees of varus or over 10 degrees of valgus
• Body mass index over 40 kg/m2
• Significant patellofemoral osteoarthritis (Kellgren-Lawrence grade III or IV)
• Diabetes treated with insulin
• Malignancy with ongoing treatment
• Systemic glukocorticosteroid or antimetabolite medication during the last 5 years
• Conditions that do not allow general anesthesia
• Patients' denial for operative treatment and/or participation in the trial

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07201207 · VARHA/28584/13.02.02/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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