CTRI/2021/07/035056已完成未知
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 Inc0 个研究点目标入组 7 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 7
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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:
- •1. Non-inflammatory degenerative joint disease, including osteoarthritis
- •2. Avascular necrosis
- •3. Requires correction of functional deformity
- •4. 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:
- •1. Degenerative joint disease, including osteoarthritis
- •2. Rheumatoid arthritis
- •3. Avascular necrosis
- •4. Requires correction of functional deformity
- •5. 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 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 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.
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