ChiCTR-IOR-15006942尚未招募不适用
比較膝關節内注射間充質幹細胞及透明質酸用於治療膝關節炎的效用
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Functional osteoarthritis scores including WOMAC,KSS and KSFS, SF-36 and VAS pain scores will be assessed at 2 weeks, 3 months, 6 months, 9 months and 12 months post-operation
研究概览
简要总结
比較膝關節内注射間充質幹細胞及透明質酸用於治療膝關節炎的效用
研究设计
- 研究类型
- 干预性研究
- 主要目的
- 随机平行对照
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •Patients must comply with all the following criteria in order to be included in the study
- •Male and female subjects aged between 18 and < 65;
- •All patients must provide their written consent;
- •All patients must be affected by primary osteoarthritis of the knee (according to ACR - American College of Rheumatology - classification); In case a patient shows a bilateral OA, it will be included and treated for both knees;
- •All patients must have pain symptoms since at least 2 months;
- •All patients must experience, during the inclusion visit (T0), a pain level higher than or equal to 5.0 cm on a VAS scale of 10 cm;
- •6.All patients should have at least 8 years of school education;
- •7.Radiological evidence of osteoarthritis with Kellgren and Lawrence grade 2 and 3.
排除标准
- •The presence of one or more of the following criteria will exclude the patient from the study:
- •Patients with previous cases of alcoholism or drug abuse;
- •Pregnancy and breast-feeding;
- •Presence of serious pathologies;
- •Hypersensitivity towards hyaluronic acid;
- •Intra-articular infiltrations of hyaluronic acid or steroids that are in the process of being administered or that have been interrupted since less than 3 months;
- •Steroid-based systemic therapy in progress or interrupted since less than 1 month and/or anti-clotting drugs;
- •History of fractures and/or severe traumas of the knee bone;
- •Significant hematologic diseases;
- •Non-consenting patients who have not provided the written Informed Consent;
- •Mechanical instability, ligamentous laxity/deficiency and gross deformity;
- •Isolated meniscal tear without evident of osteoarthritis.
研究组 & 干预措施
Two groups
To compare the effect of mesenchymal stem cells and hyaluronic acid on treating osteoarthritis of the knee, after intra-articular injection of both
结局指标
主要结局
Functional osteoarthritis scores including WOMAC,KSS and KSFS, SF-36 and VAS pain scores will be assessed at 2 weeks, 3 months, 6 months, 9 months and 12 months post-operation
Radiologic knee osteoarthritis will be assessed by MRI-and X-ray before operation, 3 months and 12 months post-operation
Adverse event will be monitored during the study
次要结局
- Analgesic/NSAIDs consumption
- Crackling sounds with movement (subjective evaluation)
- Per-articular swelling (thigh and knee circumference evaluation)
研究者
研究点 (1)
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