跳至主要内容
临床试验/EUCTR2006-002198-32-NL
EUCTR2006-002198-32-NL进行中(未招募)不适用

Prospective randomized study of the effect of autologous concentrated thrombocytes versus corticosteroid injections in lateral epicondylitis. - autologous thrombocytes injections in lateral epicondylitis.

Biomet0 个研究点目标入组 230 人开始时间: 2006年5月10日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
230

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

  • a. Men and women with lateral epicondylitis > 3 months
  • b. Baseline elbow painscore > 5/10, > 100/200 during resisted wrist extension
  • c. Informed consent
  • d. Pain by palpation of the lateral epicondyle
  • e. Pain that is unresponsive to physical therapy or a brace.
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • a. < 18 years of age
  • b. History of any blood disorder
  • c. History of bleeding disorder
  • d. History of carpal tunnel syndrome
  • e. Cervical radiculopathy
  • f. Systemic disorders such as diabetes, rheumatoid arthritis, and hepatitis
  • g. Un-cooperative patient or patient with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations
  • h. Previous surgery or corticosteroidinjections for lateral epicondylitis
  • i. Active bilateral elbow tendinosis
  • j. Hypothyroidism
  • k. Hemoglobin above or below the following range 14.0-17.7 g/dl
  • l. Hematocrit: outside of the following range: 40.0-52.0%
  • m. Platelet counts outside of the following range: 150-400 x103/dl
  • n. Arthrosis or fracture of the elbow, as confirmed by X-ray diagnosis (AP, lateral views)
  • o. Do not speak Dutch

研究者

发起方
Biomet

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