Autologous conditioned serum (Orthokine®) compared with hyaluronic acid and placebo injections for the treatment of osteoarthritis. A prospective, randomized, placebo-controlled, double-blind, parallel-design, multicenter trial.

Orthogen (Germany)0 个研究点目标入组 400 人开始时间: 2005年10月19日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Age: over 30 years old
•2. Chronic knee pain for at least 3 months measured according to American College of Rheumatology (ACR) criteria (Altman, Asch, et al. 1986)
•3. X-ray signs of uni- or bi-lateral osteoarthritis of the knee joint (Kellgren 2 or 3; Ravaud & Dougados 1997)
•4. Signed written informed consent
•5. At least pain grade 5 (measured on a visual analogue pain scale 0-10)

•Pathologies:
•1. Systemic disease of the musculoskeletal system
•2. Bone cancer, metastasis or tumor-like lesions in the immediate proximity to the treated joint
•3. Fracture in the last 3 months
•4. Acute bacterial infection of the knee to be treated
•5. Conditions, internal or oncological, which impair the patient?s general fitness (performance status [PS] >2; New York Heart Association [NYHA] >II)
•6. Blood clotting disorders
•7. Osteonecrosis of the knee to be treated
•1. Treatment of the affected knee due to osteoarthritis with one of the three study medications in the last 6 months
•2. Present psychiatric disease requiring therapy
•3. Ongoing corticoid therapy
•1. Operation on the affected knee within the last 3 months
•2. Pregnant or breast-feeding patients
•3. Drug dependency (alcohol, analgesics, opiates, etc.)
•4. Lack of mental ability to understand the study procedures due to lack of optimal communication capacity (knowledge of the language, dementia, lack of time)

发起方

Orthogen (Germany)