NCT02912351已完成不适用
A Post-Market, Single-Center, Retrospective Study to Collect Clinical Outcomes and Safety Data From Patients Who Have Undergone Revision Total Knee Arthroplasty Using Medacta GMK® Revision Prosthesis and Are at Least 2 Years Past Surgery
Medacta USA1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Total Knee Society Scores (KSS)
研究概览
简要总结
This is a retrospective, single-site observational study, designed to assess the clinical outcomes and collect safety data of GMK Revision knee system used for primary or revision total knee arthroplasty at minimum two years post-treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to any study procedure.
- •Patients with ability to understand and provide written authorization for use and disclosure of personal health information
- •Patients must be willing to comply with the post-operative evaluation schedule.
- •Patients underwent either a primary or revision total knee replacement for any type of etiology (Osteoarthritis, Avascular necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis, Polyarthritis, Primary implantation failure).
- •Patients must have received a GMK Revision component
- •Patients must be at minimum 2 year (24 months) post-treatment
- •The operation was performed or supervised by the investigator.
- •No age limit criteria
排除标准
- •History of alcoholism
- •Currently on chemotherapy or radiation therapy
- •Habitual use of narcotic pain medications prior to surgery or after surgery for reasons other than knee pain
- •History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
- •History of chronic pain issues for reasons other than knee pain
- •Women that are pregnant
结局指标
主要结局
Total Knee Society Scores (KSS)
时间窗: Minimum 2 years post surgery
Total Knee Society Score questionnaire to assess Patient satisfaction and Patient expectations and objective knee scores.
次要结局
- Radiographic Analysis(Minimum 2 years post surgery)
- Patient Satisfaction(Minimum 2 years post surgery)
- Complication Assessment(minimum 2 years post surgery)
研究者
研究点 (1)
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