Treatment for Knee Osteoarthritis With Injections of Autologous Concentrated Bone Marrow Aspirate at the Bone-cartilage Interface Via Percutaneous. Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- improvement of the International Knee Documentation Committee (IKDC) subjective score
研究概览
简要总结
This pilot study will evaluate the clinica! and radiological results of a treatment for knee osteoarthritis with injections of autologous concentrated bone marrow aspirate at the bone-cartilage interface via percutaneous.
详细描述
This pilot study (N=30) patients will evaluate the clinica! and radiological results of a treatment for knee osteoarthritis with injections of bone marrow concentrate (BMC),obtained from the Bone Marrow Aspirate Concentration System (BioCUE) at the bone-cartilage interface via percutaneous injections. The PerFuse system will also be evaluated to determine if it can be used to deliver the BMC to the osseous sites. Follow-up is 1, 3, 6, 12, and 24 months.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ranging from 40 to 75
- •Osteoarthritis of the medial or lateral compartment (2-3-4 grade according to the Kellgren-Lawrence score);
- •Failure after at least 6 months of conservative treatment (drug therapy with NSAIDs,hyaluronic acid,platelet-rich plasma and corticosteroids injections);
- •Signature of informed consent.
排除标准
- •Patients with trauma in the 6 months prior to the intervention;
- •Patients with malignancies;
- •Patients with rheumatic diseases;
- •Patients with diabetes;
- •Patients suffering from metabolic disorders of the thyroid;
- •Patients being abuse of alcohol, drugs or medications;
- •Body Mass Index> 35;
结局指标
主要结局
improvement of the International Knee Documentation Committee (IKDC) subjective score
时间窗: Time Frame: 1,3,6, 12, 24 months evaluation
(International Knee Documentation Committee)
次要结局
- evaluation of WORMS score for MRI(Time Frame: 6, 12, 24 months evaluation)
- improvement of the Knee Injury and osteoarthritis Outcome Score (KOOS)(Time Frame: 1,3,6, 12, 24 months evaluation)