A Prospective, Multi-Center Post-Market Clinical Study Evaluating the Safety, Performance, and Clinical Benefits of the Persona® SoluTion® PPS Femur
概览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in KOOS JR Score between pre-op and 2 years post-op
概览
简要总结
The goal of this study is to generate clinical evidence and evaluate the safety and performance of the Persona® SoluTion® PPS Femurs in the US market, with data supporting global regulatory submissions, including CE marking under EU MDR.
The target population consists of adults undergoing knee arthroplasty with the Persona SoluTion femoral component paired with a Medial Congruent (MC) or Posterior Stabilized (PS) articulating surface in line with its current cleared Instructions for Use (IFU).
The primary endpoint is the assessment of clinical performance and benefits by evaluating the average change in the KOOS JR score between pre-operative and 2-year post-operative follow-up.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is of legal age of consent and skeletally mature
- •Patient is willing and able to provide written Informed Consent by signing and dating the IRB/EC approved Informed Consent document
- •Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol
- •Patient qualifies for total knee arthroplasty based upon physical exam and medical history and meets the approved indications for use of the Persona® SoluTion® PPS femoral implant and appropriate compatible components, within a pre-specified variant configuration (cohort).
- •A clinical decision has been made to use the Persona® SoluTion® PPS femoral implant prior to enrollment in the research
排除标准
- •Patient is currently participating in any other surgical intervention or pain management study
- •Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)
- •Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions
- •Patient has a condition which would, in the judgement of the Investigator, place the patient at undue risk or interfere with the conduct of the study
- •Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
- •Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint
- •Insufficient bone stock on femoral or tibial surfaces
- •Skeletal immaturity
- •Neuropathic arthropathy
- •Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
研究组 & 干预措施
Persona® SoluTion PPS CR Femur with MC Bearing, cementless
This cohort will consist of subjects who receive the Persona® SoluTion PPS Cruciate Retaining Femur with the Medial Congruent Bearing, with cementless fixation.
干预措施: Total knee arthroplasty (Device)
Persona® SoluTion PPS PS Femur with PS Bearing, cementless
This cohort will consist of subjects who receive the Persona® SoluTion PPS Posterior Stabilized Femur with the Posterior Stabilized Bearing, with cementless fixation.
干预措施: Total knee arthroplasty (Device)
Persona® SoluTion PPS CR or PS Femur, cemented
This cohort will consist of subjects who receive the either the Persona® SoluTion PPS Cruciate Retaining Femur (with the Medial Congruent Bearing) or Posterior Stabilized Femur (with the Posterior Stabilized Bearing), with cemented fixation.
干预措施: Total knee arthroplasty (Device)
结局指标
主要结局
Change in KOOS JR Score between pre-op and 2 years post-op
时间窗: 2 years
A 7-item shortened version of the Knee injury and Osteoarthritis Outcome Score (KOOS), specifically designed to assess knee health in patients undergoing total knee arthroplasty (TKA). Raw scores are converted to an interval score ranging from 0 to 100, where 0 represents complete knee disability and 100 represents perfect knee health (higher scores indicate less pain and better function).
次要结局
- KOOS JR Score(5 years)
- Oxford Knee Score (OKS)(5 years)
- EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire(5 years)
- Numeric Rating Scale (Pain)(5 years)
- Survival Rate of Implant(10 years)
- Frequency and types of Adverse Events(10 years)
- Assessment of the prevalence of metal hypersensitivities using a metal Lymphocyte Transformation Test (LTT)(10 years)