NL-OMON53848已完成不适用
A Multi-Centre Study in Patients Undergoing Total Knee Replacement with Smith+Nephew Porous Total Knee Arthroplasty (TKA) System. - POROUS.TKA.SYSTEM.2021.07
Smith&Nephew, Inc0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subject needing primary TKA due to degenerative joint disease (primary
- •diagnosis of osteoarthritis), post-traumatic arthritis or inflammatory
- •2. Subject agrees to consent and to follow the prospective study visit schedule
- •(as defined in the study protocol and informed consent form) by signing the
- •Independent Review Board (IRB)/Independent Ethics Committee (IEC) approved
- •informed consent form.
- •3. Subject is willing to attend study follow-up visits for up to five (5) years
- •post-surgery.
- •4. Subject is able to read, understand, and communicate responses to Patient
- •Reported Outcome assessments.
- •5. Subject is 18-80 years old (inclusive).
排除标准
- •1. Subject received TKA on the contralateral knee as a revision for a
- •previously failed total or unicondylar knee arthroplasty.
- •2. Subject has a Body Mass Index (BMI) >= 40 at time of surgery.
- •3. Subject has ipsilateral hip arthritis resulting in flexion contracture.
- •4. At the time of enrolment, subject has one or more of the following
- •arthroplasties that are not fully healed and well-functioning, as determined by
- •the investigator: Ipsilateral or contralateral primary total hip arthroplasty
- •or hip resurfacing arthroplasty; Contralateral primary total knee or
- •unicondylar
- •knee arthroplasty.
- •5. Subject has a condition that may interfere with the TKA survival or outcome
- •(e.g. Paget*s or Charcot*s disease, vascular insufficiency, lupus, muscular
- •atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or
- •neuromuscular disease).
- •6. Subject has a known allergy to one or more of its components of the study
- •7. Any subject with hardware present in distal femur or proximal tibia.
- •8. Any subject that meets the definition of a Vulnerable Subject per ISO 14155
- •Section 3.55.
- •9. Subject is entered in another drug, biologic, or device study or has been
- •treated with an investigational product in the past 30 days.
- •10. 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, drug or alcohol abuse.
- •11. Subject is known to be at risk for lost to follow-up, or failure to return
- •for scheduled visits.
- •12. Women who are pregnant, nursing, or of child-bearing potential who are not
- •utilizing highly effective birth control measures at the time of screening or
- •the time of surgery or do not engage in a sexual lifestyle that makes pregnancy
- •impossible (e.g. homosexual or are without a sexual partner).
- •13. Subjects who have participated previously in this clinical trial and who
- •have been withdrawn.
研究者
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