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
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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