A Prospective, Multi-center, Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) and Total Knee Arthroplasty (TKA) Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 16
- 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 post-operative leg alignment to check that the results of the operation are similar to what the surgeon originally planned.
Research participants / locations:
Research participants will be recruited from up to 8 sites in 4 countries globally (UK, US, Germany and India).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject's treating clinician has decided that REAL INTELLIGENCE™ CORI™ 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 3.55.
结局指标
主要结局
Post-Operative Leg Alignment
时间窗: 6 weeks
The number of participants with knees achieving post-operative leg alignment was taken by radiographic assessment at 6 weeks. Post-operative leg alignment was achieved when the deviation from the participant specific target did not exceed ±3 degrees. Participants achieving post-operative leg alignment were categorized by the following procedure types: Unicondylar Knee Arthroplasty (UKA), Total Knee Arthroplasty (TKA), and overall (i.e., both procedures).
Percentage of Knees Achieving Post-Operative Leg Alignment
时间窗: 6 weeks
The percentage of knees achieving post-operative leg alignment taken by radiographic assessment at 6 weeks. Post-operative leg alignment was achieved when the deviation from the participant specific target did not exceed ±3 degrees. Percentage of knees achieving post-operative leg alignment were categorized by the following procedure types: Unicondylar Knee Arthroplasty (UKA), Total Knee Arthroplasty (TKA), and overall (i.e., both procedures).
次要结局
- Oxford Knee Score (OKS)(Pre-op, 6 weeks, 6 months and 12 months)
- Component Alignment: Femoral Antero-Posterior (A/P) Angle(6 weeks)
- Component Alignment: Tibial Antero-Posterior (A/P) Angle(6 weeks)
- Component Alignment: Total Valgus Angle(6 weeks)
- Component Alignment: Femoral Flexion Angle(6 weeks)
- Component Alignment: Tibial Lateral Angle(6 weeks)
- Radiographic Assessment: Radiographic Findings(12 months)
- 2011 Knee Society Score (KSS): Objective Score(Pre-op, 6 weeks, 6 months and 12 months)
- 2011 Knee Society Score (KSS): Function Score(Pre-op, 6 weeks, 6 months and 12 months)
- 2011 Knee Society Score (KSS): Satisfaction Score(Pre-op, 6 weeks, 6 months and 12 months)
- Forgotten Joint Score (FJS)(6 weeks, 6 months and 12 months)
- Five-level EuroQol Five-dimensional (EQ-5D-5L) Visual Analogue Scale (VAS) Score(Pre-op, 6 weeks, 6 months and 12 months)
- Five-level EuroQol Five-dimensional (EQ-5D-5L) Index Score(Pre-op, 6 weeks, 6 months and 12 months)