RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques

Официальное название

ROCKETS: RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques in a Randomized, Multicenter, Preference-tolerant Study

Обзор

Rationale for conducting the study: The study aims to systematically evaluate the clinical and economic impacts of Robotic-Assisted Total Knee Replacement (RTKR) compared to conventional Total Knee Replacement (TKR). It focuses on the potential benefits of RTKR, including improved precision in surgery, potentially leading to better patient outcomes and reduced healthcare costs. Our primary endpoint is the Forgotten Joint Score (FJS), aimed at measuring patients awareness of their knee joint in everyday life, indicating the success of the knee replacement surgery in restoring natural joint function. Secondary endpoints include patient-reported outcome measures (PROMs), patient activity levels, the accuracy of implant positioning on x-ray, and the incidence of adverse events. Study design: Multicentre,, preference-tolerant, randomized, controlled, superiority trial with two treatment arms that compares the outcomes of RTKR with traditional TKR techniques. Study population: Adult patients aged 18 years and older who are eligible for TKR as per local guidelines and who have given informed consent to participate in the study. Number of patients: 400 Inclusion criteria: Patients must be adults aged 18 years and older, eligible for TKR according to local guidelines, and willing to participate in the study. Exclusion criteria: Patients with extreme malalignment requiring special implants or techniques, patients unfit for surgery due to medical reasons, and those deemed unsuitable to participate in the study for other reasons. Primary outcome variables: The Forgotten Joint Score (FJS) at 2 years after surgery

Вмешательства

• Процедура Patients will be randomized to undergo TKR or RTKR
  Total knee replacement (control group)

Первичные конечные точки

• The Forgotten Joint Score (FJS) [Срок оценки: 24 months post surgery]

Вторичные конечные точки (6)

• KOOS [Срок оценки: preop, 6 weeks, 12 and 24 months post surgery]
• ADLS knee instability [Срок оценки: 6 weeks, 12 and 24 months post-operation.]
• The Forgotten Joint Score (FJS) [Срок оценки: 6 weeks and 12 months post surgery]
• EQ-5D [Срок оценки: 6 weeks, 12 and 24 months post surgery]
• Knee alignment [Срок оценки: 6 weeks post surgery]
• Adverse events [Срок оценки: up to 24 months post surgery]

Критерии участия

Критерии включения

• Adults aged 18 years and older.
• Eligible for TKR according to local guidelines and routines.
• Willingness to participate in the study.

Критерии исключения

• Patients with extreme malalignment necessitating special implants or techniques.
• Patients unfit for surgery due to other medical reasons.
• Patients who, for other reason such as alcohol or substance abuse, is deemed unsuitable to participate in the study.
• Patients who, for other reasons can't fulfill the required patient recorded outcome measures

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

Простое слепое

Основная цель

Лечение

Центры проведения

Швеция · 1 центр

• Danderyds Sjukhus — Stockholm

Идентификаторы

NCT: NCT06389435 · 2024DS · Knee

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗