Randomized Double-blind Study on the Treatment of Osteoarthritis of the Bilateral Knee: Autologous Bone Marrow Concentrate vs. Hyaluronic Acid
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- International Knee Documentation Committee (IKDC)-Subjective score
研究概览
简要总结
OA-bi-Blind is a randomized double-blind study on the treatment of osteoarthritis of the Bilateral knee: autologous bone marrow concentrate vs. hyaluronic acid.
详细描述
a randomized, controlled, double-blind study and we will be evaluated and compared the clinical and radiological results of concentrated autologous bone marrow against the hyaluronic acid in patients with bilateral knee osteoarthrosis . In randomization, one knee will be treated with autologous bone marrow concentrate and other knee with hyaluronic acid, then every patient is considered both in control and treatment group, limiting the heterogenity between groups and will not be informed of the knee assigned to the treatment group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
cover the syringe to mask the contents
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female patients, aged between 18 and 75 years;
- •Bilateral symptomatic knee osteoarthritis (Kellgren-Lawrence grade 1-4);
- •Failure after two months of conservative treatment;
- •Capacity and consent of patients to participate actively in the rehabilitation protocol, follow-up clinic and radiology protocol;
- •Signature of informed consent.
排除标准
- •Patients incapable of discernment;
- •Patients with malignancy
- •Patients with rheumatic diseases;
- •Patients with diabetes;
- •Patients with metabolic disorders of the thyroid;
- •Patients belonging abuse of alcohol, drugs or medications;
- •Patients with misalignment of the lower limbs than 10 °;
- •Body Mass Index> 40;
- •Patients with a history of trauma or intra-articular infiltration of therapeutic substances within 6 months prior to treatment.
研究组 & 干预措施
autologous bone marrow concentrate
concentration of bone marrow taken from the patient's right tibia using Bio-MAC® suction catheter, company Biologic Therapies, Inc., and concentrated by centrifuge Bio.SPINTM Magellan®, company Biologic Therapies , Inc., and its injection in the intra-articular.
干预措施: injection of autologous bone marrow concentrate (Biological)
hyaluronic acid.
single injection of intra-articular hyaluronic acid 60mg (4 cc), and serve as a control.
干预措施: injection of hyaluronic acid. (Biological)
结局指标
主要结局
International Knee Documentation Committee (IKDC)-Subjective score
时间窗: Time Frame: 6 months
Clinical improvement, measured by the change in scores IKDC Subjective
次要结局
- International Knee Documentation Committee (IKDC)-Subjective score(Time Frame: 1,3,6, 12, 24 months evaluation)
- Knee Injury and Osteoarthritis Outcome Score (KOOS).(Time Frame: 1,3,6, 12, 24 months evaluation)