Effect of Infiltrative Treatment of Stromal Vascular Fraction in Patellar Tendinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire
研究概览
简要总结
The aim of the study is the evaluation of clinical and radiological results after the treatment of patellar tendinopathy through the injection of autologous ultrasound-guided, intra- and peri-tendon stromal vascular fraction.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will be treated according to the study protocol.
Every patients will undergo to a single peri- and intra- tendon injection with Autologous Stromal Vascula Fraction (SVF).
At baseline and at every follow-ups patients will be evaluated clinically and radiologically.
In particular, clinical evaluation and questionnaires will be performed at baseline, 1, 3, 6, 12 and 24 months visits, Ultrasound will be performed at baseline, 6 and 12 months visits. MRI will be performed at baseline and 6 months visits.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ultrasound or MRI signs of patellar tendon pathology
排除标准
- •BMI > 30
- •Patients suffering from: rheumatic diseases, diabetes, infectious processes, epilepsy, severe osteoporosis
- •Patients undergoing intra-tendon infiltration of another substance within the previous 6 months;
- •Patients who had patellar tendon surgery within the previous 12 months;
- •Immunodepression
- •On going systemic inflammatory diseases (stabilized outcomes of such diseases are not considered absolute contraindications).
结局指标
主要结局
Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire
时间窗: 6 months
VISA-P score is a questionnaire that assesses symptoms, simple tests of function, and the ability to play sports. It contains 8 questions about patellar tendinosis, max score for asymptomatic individual is 100; theoretical minimum is 0
次要结局
- Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire(Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone))
- EuroQol Visual Analogue Scale (EQ-VAS)(Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone))
- Tegner score(Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone))
- MRI evaluation(baseline and 6 month)
- ultrasound(baseline, 6 and 12 months)
- Visual Analog Scale - VAS(Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone))
- EQ-5D(EuroQol)(Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone))