NCT02116946终止2 期
Intratendinous Injections of Platelet Rich Plasma With or Without Leukocyte Enrichment for Patellar Tendinopathy: a Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 64
- 试验地点
- 8
- 主要终点
- Clinical Efficacy
研究概览
简要总结
This is a randomized controlled clinical trial to investigate the effectiveness, safety and tolerability of platelet-rich plasma (PRP) injections for treatment of patellar tendinopathy in adults 18-50 years of age. Subjects will be randomly assigned to three parallel treatment groups:
- Leukocyte-rich PRP injection + exercise
- Leukocyte-poor PRP injection + exercise
- Saline injection + exercise (control) Primary endpoints are (1) the number (rate) and severity of adverse events as reported by both patients and study physicians during the first 12 weeks after initiation of treatment, (2) patient-rated tolerability of treatment; (3) the change in function (VISA score) and treatment success (global improvement scale) over six months of a post-injection exercise protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 and ≤ 50 years of age at Enrollment Visit
- •Documentation of a clinical diagnosis of patellar tendinopathy, grade-IIIB Blazina stage, confirmed on ultrasound
- •Previously tried an exercise program of at least six weeks duration
- •Fluent in official language of study site
- •Written informed consent obtained from subject
- •Normal values on screening laboratory panels (CBC, PT, PTT, INR, serum creatine, ALT, ALP, AST, bilirubin, albumin)
排除标准
- •For women of child-bearing potential, positive pregnancy test at enrollment visit
- •Major surgery in the past three months
- •Surgery on the symptomatic knee
- •Bleeding disorder
- •Systemic inflammatory disease
- •Arthritis or degenerative knee condition
- •Recent fluoroquinolone use
- •Subjects who have any requirement for the use of systemic steroids or immunosuppressants
- •Subjects who are known to be HIV positive
- •Uncooperative patient, or patients who are incapable of following directions or who are predictably unwilling to return for follow-up examinations
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
研究组 & 干预措施
Leukocyte-rich Platelet Rish Plasma + exercise
Experimental
Leukocyte-rich PRP injection and a 12 week exercise program.
干预措施: Platelet Rich Plasma (PRP) (Biological)
Leukocyte-poor Platelet Rich Plasma + exercise
Experimental
Leukocyte-poor PRP injection and a 12 week exercise program.
干预措施: Platelet Rich Plasma (PRP) (Biological)
Saline + exercise
Placebo Comparator
Saline injection and a 12 week exercise program.
干预措施: Saline + exercise (Other)
结局指标
主要结局
Clinical Efficacy
时间窗: 2 years
Number and frequency of adverse events will be assessed/reported weekly for the first 12 weeks and at the 6 month visit.
次要结局
- Change in function over time measured by VISA Score(2 years)
- Comparison of treatment success measured by Likert Global Improvement Scale(2 years)
- Change in activity levels over time measured by Tegner Activity Score(2 years)
- Change in activity-related pain over time measured by Pain Numeric Rating Scale(2 years)
研究者
Alexander Scott
Principal Investigator
University of British Columbia
研究点 (8)
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