PROSPECTIVE, MULTICENTRE POST-MARKETING SURVEILLANCE STUDY to ASSESS PERFORMANCE of the GMK UNI ANATOMICAL CEMENTLESS IMPLANT
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 249
- 试验地点
- 5
- 主要终点
- New Knee Society Score (KSS)
研究概览
简要总结
Unicompartmental Knee Arthroplasty (UKA) is the principal surgical alternative to Total Knee Arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee. The current post-marketing surveillance study aims to monitor GMK-UNI monocompartmental knee prosthesis performances over a 10-year time period.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with disease that meets the indications for use for Medacta implants included in this study (on-label use);
- •Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery;
- •Patient's age between 18 and 75 years old;
- •Patients must be willing to comply with the pre and postoperative evaluation schedule.
排除标准
- •Patients with one or more medical conditions identified as a contraindication defined by the labelling on any Medacta implants used in this study;
- •Any patient who cannot or will not provide informed consent for participation in the study;
- •Patients who need a revision surgery
- •Patients unable to understand and take action;
- •Any case not described in the inclusion criteria;
- •Patients aged under 18 years;
- •Patients aged over 75 years;
结局指标
主要结局
New Knee Society Score (KSS)
时间窗: Preoperative, 3 months, 1, 2, 3, 5, 7 and 10 years
The new Knee Society Knee Scoring System is both physician and patient derived. It includes versions to be administered preoperatively and postoperatively. It has an initial assessment of demographic details, including an expanded Charnley functional classification. The objective knee score, completed by the surgeon, includes a VAS score of pain walking on level ground and on stairs or inclines, as well as an assessment of alignment, ligament stability, and ROM, along with deductions for flexion contracture or extensor lag. Patients then record their satisfaction, functional activities, and expectations. Given the diverse activity profiles of many contemporary patients, the functional component of the score was improved to include a patient-specific survey, which evaluates features such as standard activities of daily living, patient-specific sports and recreational activities, patient satisfaction, and patient expectations
次要结局
- Kujala Score(3 months, 1, 2, 3, 5, 7 and 10 years)
- Survival of the implant(3 months, 1, 2, 3, 5, 7 and 10 years)
- Safety of the implant(Intraoperative, 3 months, 1, 2, 3, 5, 7 and 10 years)