Post-Market Data Collection for Chronic Lateral Epicondylitis Patients Treated With Leukocyte- and Platelet-Rich Plasma (L-PRP) Prepared With the Recover Mini Platelet Separation Kit
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The primary objective of the study will be to measure number of patients who achieve resolution of chronic LE symptoms at 6 months following initial injection with Recover L-PRP.
研究概览
简要总结
The objective of the study is to further characterize the performance of L-PRP prepared using the Biomet Recover Kit in the treatment of chronic LE. The study will explore the potential impact of patient demographics and baseline characteristics on treatment outcome. Furthermore it will track and document treatment effects, time course, and untoward effects following treatment of chronic LE with L-PRP from the Recover device. In addition, the utilization of healthcare resources and associated costs will be investigated in treated patients.
详细描述
Clinical trials have been conducted to determine the efficacy and safety of Leukocyte- and Platelet-Rich Plasma (L-PRP) prepared with Biomet Recover L-PRP Mini Platelet Separation Kit for the treatment of tendinosis in a controlled setting. This study will allow for the capture and evaluation of real-world clinical data on a chronic LE patient population. The advantage of a post-market data collection is that it provides a way to examine clinical and patient reported outcomes along with the associated costs of chronic LE treatment in a diverse, clinically-relevant population. Although several registries exist which capture the outcomes following tendon/ligament reconstruction surgery, there are no known registries that capture outcomes following non-surgical treatment of chronic LE with Recover L-PRP. This study will fill that gap by allowing for an efficient data collection platform in a larger heterogeneous population of patients suffering from chronic LE and will document and more closely examine the treatment effects of Recover L-PRP.
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
- •Signed an independent ethics committee (IEC)-approved informed consent form (ICF).
- •Male or female of ≥ 18 years of age
- •Confirmed diagnosis of unilateral chronic LE
- •Duration of chronic LE symptoms ≥ 3 months
- •Failed at least one previous LE treatment (e.g. wait and see, physiotherapy, analgesics, NSAIDs, anti-inflammatory steroid injection and bracing, etc.).
排除标准
- •No active systemic inflammatory condition (e.g., rheumatoid arthritis)
- •No active leukemia or metastatic malignant cells
- •No current chemotherapy treatments
- •No pregnancy
- •No lactation
- •No infected tendons, skin infection or skin disease in the area of the injection site.
- •Participating in another drug or device study.
结局指标
主要结局
The primary objective of the study will be to measure number of patients who achieve resolution of chronic LE symptoms at 6 months following initial injection with Recover L-PRP.
时间窗: 6 months
次要结局
- European Quality of Life 5 Dimensions 3 Levels (EQ-5D-3L)(Evaluated at 3, 6, 12, 24 and 36 months)
- Adverse events of interest(Evaluated at 3, 6, 12, 24 and 36 months)
- Resource utilization(Evaluated at 3, 6, 12, 24 and 36 months)
- Numeric Rating Scale (NRS)(Evaluated at 3, 6, 12, 24 and 36 months)
- Disability of the arm, shoulder and hand (QuickDASH) questionnaire(Evaluated at 3, 6, 12, 24 and 36 months)
- Number of injections of Recover L-PRP per patient in patients reaching symptom relief(Evaluated at 3, 6, 12, 24 and 36 months)
- Number of patients who have no recurrence of chronic LE within 36 months of the initial L-PRP injection(Evaluated at 3, 6, 12, 24 and 36 months)