Homologous PRP Versus Placebo in the Infiltrative Treatment of Knee Osteoarthritis in Over 65 Years Old Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- KOOS-Pain Score
研究概览
简要总结
The aim of the study is to compare the 6 months clinical outcome of the treatment with a single injection of Homologous PRP versus single injection of placebo (saline solution) in the infiltrative treatment of knee osteoarthritis in over 65 years old patients. The evaluation will be performed through clinical, subjective and objective assessments.
详细描述
204 patients affected by knee osteoarthritis will be included in a double-blinded RCT with possibility ,after 6 months, to cross-over from control arm ( saline solution ) to the treatment arm (Homologous PRP). Patients will be followed-up with clinical evaluation at 1,3 and 6 months. During the follow-up visits ,will be evaluated the inflammatory status of the knee by thermographic assessment. Patients in the treatment arm (Homologous PRP) will be followed for an additional 6 months (up to 12 months of follow-up). After 6 months, patients in the control arm have the possibility to cross-over into the treatment arm, in which case they will be followed for an additional 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This is a double-blind randomized controlled trial with 1:1 allocation. Patient blinding will be provided during the injection treatment.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral involvement;
- •Signs and symptoms of degenerative pathology of the knee cartilage;
- •Radiographic or MRI signs of degenerative pathology of the knee cartilage (Kellgren-Lawrence 1-4 grades);
- •Ability and consent of patients to actively participate in clinical follow-up;
- •Signature of informed consent
排除标准
- •Patients undergoing knee surgery within the previous 12 months;
- •Patients with malignant neoplasms;
- •Patients with rheumatic diseases;
- •Patients with diabetes;
- •Patients with hematologic diseases (coagulopathies);
- •Patients with metabolic disorders of the thyroid gland;
- •Patients abusing alcoholic beverages, drugs or medications
- •Body Mass Index > 35
结局指标
主要结局
KOOS-Pain Score
时间窗: 6 months FU
KOOS-Pain Score is referred to a subscale of pain composed by 9 items. The score range considerate is 0-100.The score uses a 5-point Likert scale and each question is assigned a score from 0 to 4, where 0 indicates "no pain" and 4 "severe level of pain".
次要结局
- EQ-VAS(baseline, 1 month, 3 months, 6 and 12 months follow-up)
- EQ-5D (EuroQoL) Current Health Assessment(baseline, 1 month, 3 months, 6 and 12 months follow-up)
- Objective parameters- Range of Motion(baseline, 1 month, 3 months, 6 and 12 months follow-up)
- IKDC-Subjective Score(baseline, 1 month, 3 months, 6 and 12 months follow-up)
- Visual Analogue Scale (VAS)(baseline, 1 month, 3 months, 6 and 12 months follow-up)
- Tegner Activity Level Scale(baseline, 1 month, 3 months, 6 and 12 months follow-up)
- Patient Acceptable Symptom State (PASS)(baseline, 1 month, 3 months, 6 and 12 months follow-up)
- KOOS Score(baseline, 1 month, 3 months, 6 and 12 months follow-up)
- Objective parameters - Circumferences(baseline, 1 month, 3 months, 6 and 12 months follow-up)