Efficacy and safety of autologous conditioned serum (ACS/Orthokine®) compared with Triamcinolone in the treatment of symptomatic hip osteoarthritis. A double-blinded, randomised, controlled, parallel group trial.

Orthogen AG (Germany)0 个研究点目标入组 130 人开始时间: 2010年3月8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 hip osteoarthritic (OA) 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 hip joint (Kellgren 2 or 3; Ravaud & Dougados 1997)
•4. Signed written informed consent
•5. At least pain grade 4 (measured on a numeric rating scale 0-10)

•1. Pathologies:
•1.1. Systemic disease of the musculoskeletal system
•1.2. Bone cancer, metastasis or tumour-like lesions in the immediate proximity to the treated joint
•1.3. Fracture in the last 3 months
•1.4. Acute bacterial infection of the hip to be treated
•1.5. Conditions, internal or oncological, which impair the patient?s general fitness (performance status [PS] >2; New York Heart Association [NYHA] >II)
•1.6. Blood clotting disorders
•1.7. Osteonecrosis of the hip to be treated
•2. Treatment:
•2.1. Treatment of the affected hip due to osteoarthritis with one of the two study medications in the last 6 months
•2.2. Present psychiatric disease requiring therapy
•2.3. Ongoing corticoid or non-steroidal anti-inflammatory drug (NSAID) therapy due to other diseases
•3.1. Operation on the affected hip within the last 3 months
•3.2. Pregnant or breast-feeding patients
•3.3. Drug dependency (alcohol, analgesics, opiates, etc.)
•3.4. 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 AG (Germany)