Use of Fresh Platelet-rich Plasma With Concentrated Leukocytes or Fresh Platelet-rich Plasma Without Concentrated Leukocytes for Treating Knee Cartilage Degeneration: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- IKDC-subjective score (International Knee Documentation Committee)
研究概览
简要总结
The aim of the study is to compare the triple infiltration of Fresh Platelet Rich Plasma with concentrated Leukocytes against triple infiltration of Fresh Platelet Rich Plasma Without Concentrated Leukocytes in the treatment of Knee Cartilage Degeneration in a Double Blind Randomized Controlled Trial
详细描述
Platelet Rich Plasma has a consolidated use in the field of orthopedic surgery to reduce inflammation, promoting bone regeneration and healing of surgical wounds.
Some clinical studies demonstrated the utility of the intra-articular infiltration of Platelet Rich Plasma in the treatment of knee articular cartilage lesions, becoming a common conservative strategies in the management of these diseases.
Actually, there are some different kinds of PRP formulations, in particular, the scientific debate is focusing on the role of Leukocytes and if it is better using fresh or frozen PRP.
At the moment don't exist randomized controlled clinical studies comparing fresh PRP rich in Leukocyte against PRP poor in Leukocyte in the treatment of knee cartilage lesions.
The study has two groups of patients, the first will undergo to three infiltrations of Fresh Platelet Rich Plasma With Concentrated Leukocytes and the second will undergo to three infiltrations of Fresh Platelet Rich Plasma Without Concentrated Leukocytes, each infiltrations will be done weekly.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with degenerative pathology of the knee cartilage with:
- •Age between 18 and 75 years;
- •Unilateral involvement;
- •Signs and symptoms of degenerative pathology of the cartilage of the knee;
- •Radiographic or MRI signs of degenerative pathology of the cartilage of the knee (Kellgren-Lawrence 1-4 degrees);
- •Hemoglobin> 11 g / dl; Platelet count> 150,000 plt / mm3 (recently performed blood count);
- •No clinically significant electrocardiographic alteration (recently performed ECG).
- •Patients' ability and consent to actively participate in clinical follow-up;
- •Signature of informed consent.
排除标准
- •Patients undergone to intra-articular infiltration of another substance in the previous 6 months;
- •Patients undergone knee surgery in the previous 12 months;
- •Patients with malignant neoplasms;
- •Patients suffering from rheumatic diseases;
- •Patients suffering from diabetes;
- •Patients with hematologic diseases (coagulopathies);
- •Patients on anti-anticoagulant therapy;
- •Patients suffering from thyroid metabolic disorders;
- •Patients abusing alcoholic beverages, drugs or drugs;
- •Body Mass Index> 35;
- •Patients who have taken NSAIDs within 3 days before taking blood;
- •Patients with cardiovascular diseases for which the 150 ml blood test would be contraindicated;
- •Patients with a recently performed blood count with Hb values <11 g / dl and Platelets <150,000 plt / mm3.
结局指标
主要结局
IKDC-subjective score (International Knee Documentation Committee)
时间窗: 12 month
It is a specific subjective rating scale for te knee. Iti s one of the most reliable tools for assessing knee diseases. The survey examines three categories: symptoms, sport activity, knee function.
次要结局
- EQ-5D (EuroQoL) Current Health Assessment(baseline, 2, 6, 12, 24 months)
- EQ-VAS (EuroQol-visual analogue scales)(baseline, 2, 6, 12, 24 months)
- Tegner Activity Level Scale(baseline, 2, 6, 12, 24 months)
- KOOS score (Knee Injury and Osteoarthritis Outcome Score)(baseline, 2, 6, 12 and 24 months)