DRKS00010478招募中不适用
Prospective, open, multicentre observational clinical study to inves- tigate safety and efficacy of cell-free Autologous Conditioned Serum (ACS) in patients with knee osteoarthritis with 3 years follow-up - OrthoR
ORTHOGEN AG0 个研究点目标入组 1,000 人开始时间: 2016年11月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1) Confirmed Knee OA (Kellgren-Lawrence Grades II–IV) diagnosis with imaging proceders (e.g. x-ray, CT, MRI) not older than 6 month
- •2) Knee pain for at least 4 weeks and pain intensity NRS =5
- •3) Treatment initiation with ACS
- •4) Signed informed written Patient´s Informed Consent Form
排除标准
- •1) Previous knee operations in the last 6 months (Surgery and/or diagnostic arthroscopy)
- •2) History of clinically significant trauma
- •3) Intra-articular injections in the last 3 months with steroids, hyaluronate compounds or PRP, ACS, ACP
- •4) RA or autoimmune cause of arthritis, systemic bone or joint illnesses
- •5) Active inflammation of predominant patella-femoral disease
- •6) BMI>30
- •7) Malignancy
- •8) Infection
- •9) Pregnancy
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