Prospective, Randomised, Double Blinded Trial Comparing Effectiveness of Platelet Rich Plasma or Placebo in a Primary Meniscal Tear Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Assessment of meniscal healing by MR scanning
研究概览
简要总结
This study will compare meniscal healing augmented or without augmentation with platelet rich plasma in primary meniscal tear treatment (prolotherapy). The assessments will include validated, disease specific, patient oriented outcome measures. Results of this study will help ascertain whether platelet rich plasma may improve meniscal healing rates.
详细描述
The role of meniscal in the knee integrity is pivotal and lack or partial role of the meniscus increases rate of joint degeneration. Partial meniscal removal is the most popular procedure and meniscal repair remain in minority of arthroscopic surgeries. As criteria of inclusion to meniscal repair are very rough, still success rates of meniscal repair remain in the 60-80% range for isolated repairs. This rate is greater when performed with ACL reconstruction. The investigators believe that augmentation with platelet rich plasma as prolotherapy ill induce healing without the need for arthroscopy.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Complete horizontal 10 mm in length
- •Tear located in the vascular/avascular portion of the meniscus (chronic horizontal tear on MR)
- •Single tear of the medial and/or lateral meniscus
- •Skeletally mature patients 18-70 years of age
排除标准
- •discoid meniscus
- •arthritic changes (Kellgren Lawrence scale >2) or axial leg deformity (valgus > 6 deg)
- •inflammatory diseases (i.e. rheumatoid arthritis)
- •concominant chondral defects (> 2 ICRS)
结局指标
主要结局
Assessment of meniscal healing by MR scanning
时间窗: by 1 year
The primary outcome measures will be assessment of meniscal healing integrity by MR scanning
次要结局
- Visual Analog Scale(12 weeks, 6months, 1year post procedure)
- Knee injury and Osteoarthritis Outcome Score scale(12 weeks, 6months, 1year post procedure)
- International Knee Documentation Committee - Subjective Knee Evaluation Form(12 weeks, 6months, 1year post procedure)
研究者
Rafał Kamiński
Deputy Chair of Division
Centre of Postgraduate Medical Education