Autologous Bone Marrow Concentrate Database Outcomes Research Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Visual Analog Pain Scale
研究概览
简要总结
The purpose of this study is to determine if Bone Marrow Concentrate may be successful in the treatment of osteoarthritis. Bone Marrow Concentrate is known to contain a community of cells that has been shown to have "regenerative" properties. This study is designed to evaluate the short-term clinical and x-ray outcomes of injections for hip and knee osteoarthritis.
Inclusion Criteria:
- Subjects must be scheduled for an autologous bone marrow hip or knee injection
- Subjects must have a diagnosis of hip or knee osteoarthritis
- Subjects must be between the ages of 18 and 85
- Subjects must be willing and able to sign Informed Consent
- Subjects must be willing and able to return for scheduled follow-up evaluations
Exclusion Criteria:
- Subjects who have had any type of visco-supplementation in the treated joint within the last three months prior to enrollment
- Subjects for whom baseline data is not available
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be scheduled for an autologous bone marrow hip or knee injection
- •Subjects must have a diagnosis of hip or knee osteoarthritis
- •Subjects must be between the ages of 18 and 85
- •Subjects must be willing and able to sign Informed Consent
- •Subjects must be willing and able to return for scheduled follow-up evaluations
排除标准
- •Subjects who have had any type of visco-supplementation in the treated joint within the last three months prior to enrollment
- •Subjects for whom baseline data is not available
结局指标
主要结局
Visual Analog Pain Scale
时间窗: Baseline, 6 weeks, 3 months, 1 year
Change in subjective pain measure
Harris Hip Score or Knee Society Score
时间窗: Baeline, 6 weeks, 3 months, 1 year
Change in subjective pain, function, functional activity measurement and a clinical physical exam
Physician Global Assessment
时间窗: Baseline, 6 weeks, 3 months, 1 year
Change in physician rated disease activity measurement
次要结局
- Radiologic(Baseline, 1 year)