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临床试验/ACTRN12616000009415
ACTRN12616000009415终止1 期

A pilot study investigating the short-term outcome of intramuscular administration of pentosan polysulfate sodium for the treatment of bone marrow lesions of the knee

Paradigm BioPharmaceuticals Ltd0 个研究点目标入组 40 人开始时间: 2016年1月12日最近更新:

试验速览

阶段
1 期
状态
终止
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
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 50 Years(—)
性别
All

入选标准

  • Subjects who have experienced an acute anterior cruciate ligament (ACL) injury a minimum of 1 week and maximum of 14 weeks prior to Day 0, and have been managed conservatively with physical therapy and medications
  • Subjects with bone marrow lesions of the femur or tibia on at least 2 consecutive sagittal or coronal MRI slices as confirmed by an independent reader.
  • subjects who have experienced an acute anterior cruciate ligament (ACL) injury a minimum of 2 weeks maximum of 14 weeks prior to Day 0 and have been treated with surgical intervention to repair the acute injury within a minimum of 2 weeks and maximum of 14 weeks prior to Day 0.

排除标准

  • 1. Subjects who have been treated with surgical intervention for the ACL injury in the affected knee
  • 2. Subjects in whom surgery for the ACL injury in the affected knee is planned during the study period
  • 3. Osteonecrosis, osseous infection/inflammation or visible cartilage damage of the affected joint
  • 4. Systemic arthritis or osteoarthritis (OA) in multiple other joints

研究者

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