CTRI/2021/07/035056已完成不适用
Prospective Multicenter, Study to evaluate the Safety and Effectiveness of CORI Robotics System in Unicondylar Knee Arthroplasty (UKA) and Total Knee Arthroplasty (TKA) procedures
Smith and Nephew Inc2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2021年7月31日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Post-operative leg alignment
研究概览
简要总结
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. The data collected will be used to meet the post-market clinical follow-up requirement in Europe and to support claims and publications.
Objectives:
The primary objective of this study is to evaluate the use of CORI Robotics in UKA and TKA procedures in achieving postoperative leg alignment to check that the results of the operation are similar to what the surgeon originally planned.
Research participants / locations:
140 research participants will be recruited from up to 6 sites in 4 countries globally (UK, US, Germany and India). There will be 70 patients having UKA surgery and 70 patients having TKA surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •The subject’s treating clinician has decided that REAL INTELLIGENCEâ„¢ CORIâ„¢ and a compatible Smith+Nephew Knee Implant System is the best treatment for the subject’s unicondylar knee arthroplasty (UKA) or total knee arthroplasty (TKA) and the subject has agreed to the treatment.
- •Subject requires a cemented UKA or TKA as a primary indication that meets either criterion A or B. A. Subject requires a cemented UKA as a primary indication due to any of the following conditions:
- •Non-inflammatory degenerative joint disease, including osteoarthritis
- •Avascular necrosis
- •Requires correction of functional deformity
- •Requires treatment of fractures that were unmanageable using other techniques B. Subject requires a cemented TKA as a primary indication due to any of the following condition:
- •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 one (1) year postoperative follow-up.
- •Routine radiographic assessment is possible.
- •Subject able to follow instructions and deemed capable of completing all study questionnaires.
排除标准
- •Subject receives a CORI Robotics UKA or TKA on the index joint as a revision for a previously failed surgery, or need for complex implants, or any other implant than a standard UKA or TKA (e.g. stems, augments, or custom made devices).
- •Subject has been diagnosed with post-traumatic arthritis.
- •Subject receives bilateral UKA or TKA.
- •Subject does not understand the language used in the Informed Consent Form.
- •Subject does not meet the indication or is contraindicated for UKA or TKA according to 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
- •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 has a condition(s) that may interfere with the TKA or UKA 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, mental retardation, 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 ISO 14155 Section 3.5.
结局指标
主要结局
Post-operative leg alignment
时间窗: 6 weeks
Description:
时间窗: 6 weeks
Post-operative leg alignment via radiographic assessment. Post-operative leg alignment is achieved when the deviation from the subject specific target does not exceed ±3 degrees.
时间窗: 6 weeks
次要结局
- Component Alignment - TKA(Description: Component alignment will be assessed on long)
- 2011 Knee Society Score (KSS) - UKA(Description: Derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities in UKA subjects. Consists of 4 separate subscales:(1) An “Objective†Knee Score (seven items: 100 points), (2) A Patient Satisfaction Score (five items: 40 points), (3) A Patient Expectation Score (three items: 15 points), and (4) A Functional Activity Score (19 items: 100 points). A higher number is a better outcome.)
- Component Alignment - UKA(Description: Component alignment will be assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays)
- Radiographic assessment - UKA(Description: Radiographic assessment on antero-posterior)
- Oxford Knee Score (OKS) - UKA(Description: To specifically assess the patients perspective of outcome following knee arthroplasty surgery in UKA subjects. Responses to each question ranges from 0-4 with a range of a possible overall score from 0-48. A score of 0 is the worst possible outcome while a score of 48 is the best possible outcome.)
- Forgotten Joint Score (FJS) - UKA(Description: Joint-specific patient reported outcome in UKA subjects. Responses to 12 questions are recorded with a 5 point Likert format: Never, almost never, seldom, sometimes and mostly.)
- Radiographic assessment - TKA(Description: Radiographic assessment on antero-posterior)
- 2011 Knee Society Score (KSS) - TKA(Description: Derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities in TKA subjects. Consists of 4 separate subscales:(1) An “Objective†Knee Score (seven items: 100 points), (2) A Patient Satisfaction Score (five items: 40 points), (3) A Patient Expectation Score (three items: 15 points), and (4) A Functional Activity Score (19 items: 100 points). A higher number is a better outcome.)
- Oxford Knee Score (OKS) - TKA(Description: To specifically assess the patients perspective of outcome following knee arthroplasty surgery in TKA subjects. Responses to each question ranges from 0-4 with a range of a possible overall score from 0-48. A score of 0 is the worst possible outcome while a score of 48 is the best possible outcome.)
- Five-level EuroQol five-dimensional (EQ-5D-5L) VAS & index scores - TKA(Description: EQ-5D-5L is composed of the descriptive system & EQ Visual Analogue scale (EQ VAS). The descriptive system has 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each has 5 levels: no problems, slight, moderate, severe, & extreme problems. The EQ VAS ranges from the best health you can imagine to the worst health you can imagine. A higher number is a better outcome.)
- Forgotten Joint Score (FJS) - TKA(Description: Joint-specific patient reported outcome in TKA subjects. Responses to 12 questions are recorded with a 5 point Likert format: Never, almost never, seldom, sometimes and mostly.)
- Five-level EuroQol five-dimensional (EQ-5D-5L) VAS & index scores - UKA(Description: EQ-5D-5L is composed of the descriptive system & EQ Visual Analogue scale (EQ VAS). The descriptive system has 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each has 5 levels: no problems, slight, moderate, severe, & extreme problems. The EQ VAS ranges from the best health you can imagine to the worst health you can imagine. A higher number is a better outcome.)
研究者
研究点 (2)
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