EUCTR2013-004875-12-CZ进行中(未招募)1 期
Application of PRP (plattelet rich plasma) to the lateral epicondyle of the humerus
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 18-60 years old men or women
- •- Disability elbow withought arthrosis or a low grade of arthrosis / less than 2-nd degree of Kellgrenn classification of x-ray /
- •- Finding epicondylitis verified by clinical examination, possibly with the addition of Doppleromerie, scintigraphy, or MRI thermometry
- •- At least some positive effect of the application of local anesthetic into the treated sites at least l M prior to study
- •- Agrees with the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with acute or chronic infection or acute inflammatory complications ( general or local ), also patients treated with antibiotic therapy for suspected infectious disease during the 6 weeks before inclusion in the study or in the event of Infectious complications in observed elbow least 6 month before study .
- •Pregnant and nursing women and women of childbearing potential not using reliable contraceptive method.
- •Presumption of survival for less than two years .
- •Patients with severe disorders of blood coagulation and platelet disorders
- •Patients with bone marrow disease in history
- •Kidney disease in the last stage with dependence on dialysis
- •Using Immunosuppressive drugs
- •Known abuse of alcohol or drugs, or other factors which might affect the subject's behavior during the study or the interpretation of results
- •The patient , whose participation is considered by the investigator to be inappropriate
- •Unwillingness or inability of the patient to give informed consent to inclusion in the study
- •Application of glucocorticoids in his elbow less than 6 weeks prior to enrollment .
- •Rehabilitation measures less than 6 weeks prior to enrollment .
- •Surgical procedure less than 3month prior to enrollment .
- •X-ray signs of osteoarthritis of the elbow - over II degree by Kellgren
- •Consequences of severe injuries such as bone fracture , resulting in nonanatomical position.
研究者
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