Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure

Официальное название

A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure

Обзор

Background: REAL INTELLIGENCE™ CORI™ (CORI Robotics) is a computer-assisted orthopaedic surgical navigation and burring system. CORI Robotics is designed to help surgeons in planning and executing certain types of knee surgery involving bone preparation. These types of surgery are called 'unicondylar knee arthroplasty' (UKA) and 'total knee arthroplasty' (TKA). Purpose: This study is being carried out to demonstrate the safety and effectiveness of the CORI Robotics in TKA procedure. The data collected will be used to demonstrate the safety and effectiveness of CORI and to register CORI in China mainland. The primary objective of this study is to evaluate the use of CORI in TKA procedure in achieving post-operative leg alignment as compared to procedures using conventional manual instruments. Research participants / locations: 140 research participants will be recruited from up to 8 sites in 3 countries globally (Australia, China Mainland, Hong Kong and New Zealand). There will be 70 patients having TKA using CORI and 70 patients having TKA using conventional procedure.

Вмешательства

• Устройство CORI Robotics
  Total knee arthroplasty (TKA) treated with CORI Robotics System.
• Процедура Conventional Procedure
  Total knee arthroplasty (TKA) treated with conventional approach with conventional manual instrumentation.

Первичные конечные точки

• Post-operative Leg Alignment [Срок оценки: 6 weeks]

Вторичные конечные точки (6)

• Component Alignment [Срок оценки: 6 weeks]
• Radiographic Assessment [Срок оценки: 12 months and 24 months]
• 2011 Knee Society Score (KSS) [Срок оценки: Pre-op, 6 weeks, 6 months, 12 months and 24 months]
• Oxford Knee Score (OKS) [Срок оценки: Pre-op, 6 weeks, 6 months, 12 months and 24 months]
• Forgotten Joint Score (FJS) [Срок оценки: 6 weeks, 6 months, 12 months and 24 months]
• EuroQol Five-Dimensional Five-Level (EQ-5D-5L) [Срок оценки: Pre-op, 6 weeks, 6 months, 12 months and 24 months]

Критерии участия

Критерии включения

• Subject is a suitable candidate for a TKA procedure using CORI and a corresponding S+N Knee Implant System.
• Subject requires a cemented TKA as a primary indication that meets any of the following condition:

• Non-inflammatory degenerative joint disease, including osteoarthritis
• Rheumatoid arthritis
• Avascular necrosis
• Requires correction of functional deformity
• Requires treatment of fractures that were unmanageable using other techniques
• Subject is of legal age to consent and considered skeletally mature (≥ 18 years of age at the time of surgery)
• Subject agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the Ethical Committee (EC) or Institutional Review Board (IRB) approved informed consent form.
• Subject plans to be available through two (2) year postoperative follow-up.
• Applicable routine radiographic assessment is possible.

Критерии исключения

• Subject requires a TKA on the index joint as a revision for a previously failed surgery, or has the need for complex implants, or any other implant than a standard TKA (e.g. stems, augments, or custom-made devices).
• Subject has been diagnosed with post-traumatic arthritis.
• Subject receives simultaneous bilateral UKA OR a unilateral UKA with contralateral TKA.
• Subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator:-Contralateral primary TKA or UKA, however, the subject can only have one knee enrolled in this study.
• Subject does not understand the language used in the Informed Consent Form.
• Subject does not meet the indication or is contraindicated for TKA according to the specific Smith+Nephew Knee System's Instructions For Use (IFU).
• Subject has active infection or sepsis (treated or untreated).
• Subject is morbidly obese with a body mass index (BMI) greater than 40.
• Subject is pregnant or breast feeding at the time of surgery.
• Subject, in the opinion of the Investigator, has advanced osteoarthritis or joint disease at the time of surgery and was better suited for an alternate procedure.
• Subject currently enrolled in another orthopedic clinical trial study.
• Subject has a condition(s) that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease, or an active, local infection).
• Subject in the opinion of the Investigator has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, intellectual disability, drug or alcohol abuse.
• Subject, in the opinion of the Investigator, has a neuromuscular disorder that prohibited control of the index joint.
• Subject is a prisoner or meets the definition of a Vulnerable Subject per International Organization for Standardization (ISO) 14155:2020 Section 3.55.

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

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• Northern Hospital — Epping

Китай · 1 центр

• Jishuitan Hospital, Beijing — Пекин

Гонконг · 1 центр

• The Prince of Wales Hospital — Shatin

Новая Зеландия · 1 центр

• North Shore Hospital — Auckland

Идентификаторы

NCT: NCT04848896 · CORI.2020.08

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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