NCT04797897终止不适用
A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) Procedures
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 5
- 主要终点
- Post-operative Leg Alignment
研究概览
简要总结
This is a prospective study to demonstrate the safety and effectiveness of CORI and to register CORI in China mainland.
详细描述
This is a prospective, multi-center, randomized study to demonstrate the safety and effectiveness of CORI. In addition, the study will support regulatory approval by the National Medical Products Administration (NMPA) in China.
The study will have two arms, the investigational group will be total knee arthroplasty (TKA) using CORI, the comparison group will be conventional approach with conventional manual instrumentation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Subject is a suitable candidate for a UKA procedure using CORI and a compatible S+N Knee implant system.
- •Subject requires a cemented UKA as a primary indication that meets 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
- •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 Ethics Committee (EC) or Institutional Review Board (IRB) approved informed consent form.
- •Subject plans to be available through one (1) year postoperative follow-up.
- •Applicable routine radiographic assessment if possible.
排除标准
- •Subject receives a UKA 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 (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 UKA according to specific S+N 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 currently enrolled in another orthopedic clinical trial study.
- •Subject has a condition(s) that may interfere with the 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, 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 ISO 14155:2020 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.
次要结局
- Component Alignment: Femoral Antero-Posterior (A/P) Angle(6 weeks)
- Component Alignment: Total Antero-Posterior (A/P) Valgus Angle(6 weeks)
- Five-level EuroQol Five-dimensional (EQ-5D-5L): Visal Analogue Scale (VAS) Score(Baseline, 6 weeks, 6 months, and 12 months)
- Component Alignment: Tibial Antero-Posterior (A/P) Angle(6 weeks)
- Component Alignment: Lateral View Femoral Flexion Angle(6 weeks)
- Component Alignment: Lateral View Tibial Angle(6 weeks)
- Radiographic Assessment(12 months)
- 2011 Knee Society Score (KSS): Objective Knee Score(Baseline, 6 weeks, 6 months, and 12 months)
- 2011 Knee Society Score (KSS): Satisfaction Knee Score(Baseline, 6 weeks, 6 months, and 12 months)
- 2011 Knee Society Score (KSS): Expectation Score(Baseline, 6 weeks, 6 months, and 12 months)
- 2011 Knee Society Score (KSS): Functional Score(Baseline, 6 weeks, 6 months, and 12 months)
- Oxford Knee Score (OKS)(Baseline, 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): Index Score(Baseline, 6 weeks, 6 months, and 12 months)
研究者
研究点 (5)
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