NCT06483269招募中不适用
Homologus PRP in the Infiltrative Treatment of Knee Osteoarthritis in Young Athletic Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- International Knee Documentation Committee score
研究概览
简要总结
The study consists of 3 phases (enrollment, infiltrative procedure, and controls):
- Identification by specialized orthopedic medical staff belonging to the SC Orthopedic and Trauma Clinic II of the Rizzoli Orthopedic Institute of subjects who meet the study inclusion criteria. Signing of informed consent form and completion of evaluation questionnaires.
- infiltrative procedure
- Patients will be clinically evaluated before the infiltration procedure and at 1, 3, 6, and 12 months after treatment by trained medical personnel (outcome assessors). Questionnaires will be administered for clinical evaluations before treatment and at these clinical checkups during follow-up. Any adverse events to treatment will also be assessed during follow-up visits. The duration and extent of joint swelling and pain following infiltration will be reported, and any drug therapies taken by the patient will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, both sexes, with symptomatic knee osteoarthritis with:
- •Age: 18-40 years;
- •Unilateral involvement;
- •Signs and symptoms of knee osteoarthritis;
- •Radiographic or MRI signs of degenerative pathology of knee cartilage (Kellgren-Lawrence grade 1-3);
- •Ability and consent of patients to actively participate in clinical follow-up;
- •Signature of informed consent;
- •Pain ≥ 4 on VAS s
排除标准
- •Patients unable to express consent;
- •Patients undergoing intra-articular infiltration of other substance in the previous 6 months;
- •Patients undergoing knee surgery in the previous 12 months;
- •Patients with malignant neoplasms;
- •Patients with rheumatic diseases;
- •Patients with uncontrolled metabolic diseases;
- •Patients with hematological diseases (coagulopathies);
- •Patients abusing alcoholic beverages, drugs or medications;
- •Knee trauma treated in the previous 6 months.
- •Other conditions that may interfere with the evaluation of OA treatment.
结局指标
主要结局
International Knee Documentation Committee score
时间窗: 6 months
This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathology. The questionnaire examines 3 categories: symptoms, sports activity, and knee function.
次要结局
- Knee Injury and Osteoarthritis Outcome Score(baseline, 1, 3, 6, 12 months)
- objective parameter(baseline, 1, 3, 6, 12 months)
- Tegner Activity Level Scale(baseline, 1, 3, 6, 12 months)
- Patient Acceptable Symptom State(baseline, 1, 3, 6, 12 months)
- Expectations of treatment efficacy(baseline)
- International Knee Documentation Committee score(baseline, 1, 3, 6, 12 months)
- Visual Analogue Scale(baseline, 1, 3, 6, 12 months)
- Overall judgment on treatment(baseline, 1, 3, 6, 12 months)
研究者
研究点 (2)
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