Prospective Post-Market Data Collection on Patients With Knee Osteoarthritis and Treated With nSTRIDE Autologous Protein Solution (REGP-22-00)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Knee pain and function
研究概览
简要总结
This study will document treatment effects, changes in quality of life, procedure complications, adverse events, healthcare resource utilization, and further needed intervention(s) following treatment with nSTRIDE autologous protein solution. This study will also allow for the documentation of the same parameters following multiple injections of autologous protein solution to treat knee osteoarthritis.
详细描述
Clinical trials have, in general, formally demonstrated the effectiveness and safety of various autologous therapies for the treatment of knee OA. Differences in the processing of autologous therapies can yield substantial differences in the resulting output. It appears that the safety of autologous therapies is roughly equivalent across different processing methods. However, making generalizations regarding the effectiveness across these autologous therapies is more complicated. Thus, each autologous therapy requires independent efficacy evaluation. nSTRIDE APS has been shown to decrease pain, increase function and have a favorable safety profile in a small pilot trial. However, demonstration of the treatment effects in a more heterogeneous population is lacking. Further, neither the effect time course nor the utility of multiple injections has been documented. This study will allow for low burden, efficient data collection in a larger heterogeneous population of persons suffering from knee OA. The study will document the treatment effects and timeline of treatment effects for nSTRIDE APS following single or repeated injections.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OA of one or both knees as diagnosed by the treating physician
- •At least 18 years of age
- •Willing and able to comply with the study procedures
- •Signed informed consent form
排除标准
- •Any systemic inflammatory condition ( e.g., rheumatoid arthritis)
- •Active malignancy at time of injection
- •Pregnant at time of injection
- •Lactating at the time of injection
- •Knee joint infections or skin diseases or infections in the area of the injection site.
- •Leukemia, metastatic malignant cells, or who are receiving chemotherapeutic treatment
- •Participating in another device or drug study
结局指标
主要结局
Knee pain and function
时间窗: Through 12 months
Quantify and characterize the percentage of OMERACT-OARSI high improvement in pain responders at all post-injection time points. OMERACT-OARSI high improvement in pain responders are defined as subjects who show a 50% improvement in the KOOS pain sub-scale score and an absolute improvement of at least 20 points on the KOOS pain subscale score.
次要结局
- European Quality of Life 5 Dimensions 3 Levels (EQ-5D-3L)(Evaluated at 2 and 4 weeks and 3, 6 and 12 months)
- Numeric Rating Scales (NRS)(Evaluated at 2 and 4 weeks and 3, 6 and 12 months)
- Characterize the time from the initial nSTRIDE injection to subsequent nSTRIDE injection(s) or other intrusive treatment.(Through 12 months)
- Procedural complications and adverse events(Through 12 months)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Evaluated at 2 and 4 weeks and 3, 6 and 12 months)