BMAC vs HA in Infiltrative Therapy for Osteoarthritis of the Ankle: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- AOS (Ankle Osteoarthritis Scale)
研究概览
简要总结
The aim of the study is to compare the efficacy of the infiltrative therapy of BMAC vs HA up to 24 months in the treatment of the ankle osteoarthritis. The efficacy will be assessed through clinical, objective and subjective evaluations. After 12 months patients in the control group can decide to cross-over in the treatment group.
详细描述
All the patients who meet the inclusion criteria and giving written informed consent will be randomized. We planned to enrol 120 patients.
Following the randomization, every patient will be treated with a single injection of Bone Marrow Aspirate Concentrate (BMAC) or two injections of Hyaluronic Acid (HA) in the affected ankle.
After the treatment patients will be followed up to 24 months whit clinical and radiological assessment.
After 12 months patients in the control group can decide to cross-over in the treatment group with BMAC. These patients will be followed up further 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with degenerative ankle cartilage disease;
- •Unilateral involvement on the ankle;
- •Signs and symptoms of degenerative pathology of the ankle cartilage;
- •Radiographic or MRI signs of degenerative pathology of the ankle cartilage (OA Van Dijk grade 1-3);
- •No clinically significant electrocardiographic changes (recently performed ECG).
- •Ability and consent of patients to actively participate in clinical follow-up;
排除标准
- •Patients unable to give consent;
- •Patients who have undergone intra-articular infiltration of another substance in the preceding 6 months;
- •Patients who have undergone ankle surgery in the preceding 12 months;
- •Patients with malignant neoplasms;
- •Patients with rheumatic diseases;
- •Patients with uncompensated diabetes;
- •Patients with uncompensated thyroid metabolic disorders;
- •Patients who abuse alcoholic beverages, drugs or medications;
- •Body Mass Index > 35;
结局指标
主要结局
AOS (Ankle Osteoarthritis Scale)
时间窗: Baseline, 1, 3, 6, 12, 24 months
Evaluation of the change from baseline of the OAS score, assessing the trend of pain and function up to 24 months from the treatment
次要结局
- AOFAS (The American Orthopedic Foot and Ankle Score)(Baseline, 1, 3, 6, 12, 24 months)