Prospective Observational 5 Year Follow-up on a Consecutive Cohort of 70 Primary Total Knee Arthroplasty (TKA) Cases Treated With All-polyethylene Tibia (APT) Components of the Posterior-stabilized VEGA System PS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Revision Rate
研究概览
简要总结
Obligatory Post-Marketing Clinical Follow-up (PMCF) as part of the post marketing surveillance plan for the product under investigation For this PMCF only CE-marked medical devices will be used within their intended purpose and no additional invasive or other stressful examinations are to be carried out (acc. to MPG §23b).
详细描述
This non-interventional clinical study (NIS) is conducted to clinically confirm the safety and performance of the Aesculap® APT VEGA System® PS components under routine conditions. The VEGA System® PS is an established TKA design, and there is a long-lasting experience in the use of PE for TKA in general and for APT components in particular; thus a NIS is thought to be sufficient to give the required confirmation. For this NIS only CE-marked medical devices will be used within their intended purpose and no additional invasive or other stressful examinations are to be carried out (acc. to MPG §23b). As part of the post marketing surveillance plan an obligatory Post-Marketing Clinical Follow-up (PMCF) is required for the product under investigation.
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
- •Patients requiring primary TKA because of severe knee joint conditions that cannot be treated through other therapies;
- •degenerative osteoarthritis;
- •rheumatoid arthritis;
- •posttraumatic arthritis;
- •symptomatic knee instability;
- •knee stiffness or deformation of the knee joint;
- •Age ≥ 18 years;
- •Patient signed informed consent
排除标准
- •Age younger than 18 years
- •Any prior joint replacement at the index knee
- •Unable or unwilling to return for postoperative follow-up
- •Patient did not sign informed consent
- •Joint conditions that can be treated by reconstructive surgery (e.g. osteotomy)
- •Acute or chronic infections near the joint, or systemic infections
- •Secondary diseases that could influence joint implant functionality
- •Systemic diseases and metabolic disorders
- •Severe osteoporosis or osteomalacia
- •Severely damaged bone structures that could prevent stable implantation of implant components
- •Bone tumors in the region of implant fixation
- •Bone malformations, axial misalignments or other bone conditions that rule out implantation of a prosthetic joint
- •Expected overload on the joint implant, especially due to high patient weight or intense physical strain and activity
- •Dependency on pharmaceutical drugs, drug abuse, or alcoholism
- •Fever, infection or inflammation (systemic or local)
- •Pregnancy
- •Mental illness
- •Severe osteopenia (or any other medical or surgical finding) that would preclude any benefit from the implants
- •Combination with implant components from other manufacturers
- •Inadequate patient compliance
- •Foreign body sensitivity to the implant materials
- •All cases not listed under indications
结局指标
主要结局
Revision Rate
时间窗: 5 years
The objective of the study is to collect clinical midterm outcome information on the product under investigation when used in routine clinical practice.
次要结局
- KSS (Knee Society Score)(5 years)
- Complication/Adverse Event rate(5 years)
- KOOS (Knee Osteoarthritis Outcome Score)(5 years)
- SF-12® Health Survey (SF-12)(5 years)
- Change of anterior knee pain over follow-up period(5 years)