Prospective, Double Blind, Randomized Trial: Meniscal Repair With or Without Augmentation Utilizing Platelet Rich Plasma.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- MRA (magnetic resonance imaging arthrography
研究概览
简要总结
This study will compare meniscal healing with or without platelet rich plasma. The assessments will include validated, disease specific, patient oriented outcome measures, MRI arthrogram (MRA). Results of this study will help ascertain whether PRP improves meniscal healing rates.
Null Hypothesis: There is no difference in meniscal healing with or without the use of PRP.
详细描述
The integrity of the meniscus is pivotal to the distribution of joint reaction forces and shock absorption across the knee and meniscal damage can lead to secondary degenerative joint disease. This has lead to treatments directed towards repairing and preserving the meniscus to alter the progression of joint degeneration. Although success rates of meniscal repair are greater when performed in association with anterior cruciate reconstruction, healing rates remain in the 70-80% range for isolated repairs.
Therefore, techniques such as the use of fibrin clots, trephining and rasping of the tissues, have been incorporated to improve healing results of meniscal repair. There has been a surge of enthusiasm for the use of Platelet Rich Plasma (PRP) to improve healing rates of soft tissue injuries. Therefore, it may be reasonable to surmise that applying blood products, such as thrombin and platelet rich plasma, to the meniscal repair bed may induce more complete and possibly faster healing.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •complete vertical longitudinal tear > 10 mm in length
- •tear located in the vascular portion of the meniscus, classified as either red-red or red-white zones
- •a stable knee, or a knee that is stabilized with a concurrent ACL reconstruction
- •unstable peripheral tear that can be displaced toward center of joint
- •single tear of the medial and/or lateral meniscus
- •skeletally mature patients 18-60 years of age
排除标准
- •associated significant ligament instability: Grade III MCL, Grade III PCL
- •discoid meniscus
- •ACL deficient knee
- •Outerbridge Grade III or IV cartilage changes on arthroscopy in the involved compartment
- •Significant degenerative changes on radiographs (Kellgren Lawrence >/= Grade III)
- •Associated osteochondral defect that requires treatment
- •Inflammatory arthropathy (e.g. rheumatoid arthritis)
- •Non repairable meniscus (ie white zone, irreducible meniscus)
- •Degenerative meniscus or presence of CPP crystals in meniscus
- •Underlying bleeding disorder or coagulopathy
结局指标
主要结局
MRA (magnetic resonance imaging arthrography
时间窗: 6 months
The primary outcome measures will be assessment of meniscal healing integrity using magnetic resonance imaging arthrography six months post repair.
次要结局
- WOMET - Western Ontario Meniscal Outcome Measure(Baseline, 3 months, 6 months 12 months)
- VAS Pain Score - Visual Analog Scale(Baseline, Post-op Day 1, 6 weeks)
- Range of motion(6 weeks, 3 months, 6 months, 12 months)
- Tegner Score(Baseline, 3, 6 and 12 months post treatment)