A Multi-Centre Study in Patients Undergoing Total Knee Replacement With Smith+Nephew Porous Total Knee Arthroplasty (TKA) System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 299
- 试验地点
- 18
- 主要终点
- Implant Survivorship (femoral and/or tibial component) 2 Years Post-Surgery
研究概览
简要总结
A clinical trial investigating the safety and effectiveness of Smith and Nephew's FDA-approved Porous Total Knee System, which is used to replace worn away and diseased knee joints. The aim of this study is to show that most patients who receive the Porous Total Knee System have reduced pain, greater mobility and a long-lasting implant post-surgery.
详细描述
Patients who need a total knee replacement or have recently had a total knee replacement with the Smith and Nephew Porous Total Knee System will be enrolled into the study. Before surgery X-rays will be collected and questionnaires will be administered which ask the patient about knee pain, activities of daily living, quality of life and how they feel about their knee. The same X-rays and questionnaires will be asked before surgery and then after surgery at various intervals up to 10 years post-surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A) Subject needing primary TKA due to degenerative joint disease (primary diagnosis of osteoarthritis), post-traumatic arthritis or inflammatory arthritis.
- •B) Subject has undergone primary TKA with Smith+Nephew Porous knee system in past 12 months to repair degenerative joint disease, post- traumatic arthritis or inflammatory arthritis and all the following conditions have been met:
- •Preoperative KOOS JR and radiographs have been obtained
- •6-Month KOOS JR and radiographs have been obtained or these can be collected prospectively in window per schedule of events
- •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.
- •Subject is willing to attend study follow-up visits for up to five (5) years post-surgery.
- •Subject is able to read, understand, and communicate responses to Patient Reported Outcome assessments.
- •Subject is 18-80 years old (inclusive).
排除标准
- •Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty.
- •Subject has a Body Mass Index (BMI) ≥ 40 at time of surgery.
- •Subject has ipsilateral hip arthritis resulting in flexion contracture.
- •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.
- •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).
- •Subject has a known allergy to one or more of its components of the study device.
- •Any subject with hardware present in distal femur or proximal tibia.
- •Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.
- •Subject is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days.
- •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.
- •Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.
- •Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures.
- •Subjects who have participated previously in this clinical trial and who have been withdrawn.
研究组 & 干预措施
LEGION Porous CR with Hydroxyapatite
Patients who have already received or a due to receive a Porous Tibia + LEGION Porous CR with HA femoral component (min 117 subjects)
干预措施: Total Knee Arthroplasty (Procedure)
LEGION Porous CR without Hydroxyapatite
Patients who have already received or a due to receive a Porous Tibia + LEGION Porous CR without HA femoral component (min 117 subjects)
干预措施: Total Knee Arthroplasty (Procedure)
结局指标
主要结局
Implant Survivorship (femoral and/or tibial component) 2 Years Post-Surgery
时间窗: 2 years post-surgery
Survivorship of the femoral and/or tibial component of the implant is defined as the cumulative proportion of femoral and/or tibial components without a revision.
次要结局
- Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR)(Pre-op, 6 weeks, 6 months, 2 years, 3 years, 5 years and 10 years)
- Patient Reported Outcomes - Oxford Knee Score (OKS)(Pre-op, 6 weeks, 6 months, 2 years, 3 years, 5 years and 10 years)
- Patient Reported Outcomes - Forgotten Joint Score (FJS)(Pre-op, 6 weeks, 6 months, 2 years, 3 years, 5 years and 10 years)
- Radiographic Assessment - Implant Position(6 months, 2 years, 5 years and 10 years)
- Radiographic Assessment - Implant Migration(6 months, 2 years, 5 years and 10 years)
- Radiographic Assessment - Progressive Radiolucency(6 months, 2 years, 5 years and 10 years)
- Radiographic Assessment - Implant Loosening(6 months, 2 years, 5 years and 10 years)
- Post-Operation Device Related Re-Interventions Related to Operative Knee(Post-op through study completion, approximately 10 years)
- Implant Survival Rate Up to 10 Years Post-Operation(1 year, 2 years, 5 years and 10 years)