Randomized Double Blind Clinical Study on the Treatment of Bilateral Knee Arthrosis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
The purpose of the study is to assess the radiological and clinical outcomes comparing two different treatments (Filtered Autologous Adipose Tissue versus Placebo) in patients affecting bilateral knee osteoarthritis.
After be randomized, every patient will be treated in both legs, one leg with Adipose Tissue and the other one with Placebo.
详细描述
All patients who meet the inclusion criteria and giving written informed consent will be randomized.
Every patient will be treated with a single injection of Filtered Autologous Adipose Tissue in one knee and single injection of Placebo in the other, based on the randomization.
After the treatment patients will be followed up to 24 months.
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, Outcomes Assessor)
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
- 否
入选标准
- •bilateral degenerative chondropathy of the knees showing at least a grade 2-3 kellgren-lawrence classification (absence of severe osteoarthritis)
- •An overall Pain subscale score of the Western Ontario and McMaster Universities Osteoarthritis Index between a value of 9 and
- •Failure, intended as the persistence of symptomatology, after at least one conservative treatment cycle (pharmacological, physiotherapeutic or infiltrative treatment);
- •Ability and informed consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up;
排除标准
- •Patients incapable of understanding and wanting;
- •Diagnosis of leukaemia, known presence of metastatic malignant cells, ongoing or planned chemotherapy;
- •Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis or arthritis resulting from another inflammatory disease; infection with human immunodeficiency virus (HIV), viral hepatitis; chondrocalcinosis;
- •Patients with uncontrolled diabetes mellitus;
- •Patients with uncontrolled thyroid metabolic disorders;
- •Patients who abuse alcoholic beverages, drugs or medicines;
- •Patients with misalignment of the lower limbs above 10 degrees;
- •Body Mass Index > 40;
- •Pregnant or lactating state or intention to become pregnant during the period of participation in the study.
- •Patients with a history of trauma or intra-articular infiltration of therapeutic substances in the 6 months prior to screening.
- •Patients who have had knee surgery in the 12 months prior to screening.
- •Patients with insufficient abdominal adipose tissue, assessed by the investigator
研究组 & 干预措施
Filtered Autologous Adipose Tissue
based on randomization one of the two knees will be treated with a single injection of Filtered Autologous Adipose Tissue
干预措施: injection of Filtered Autologous Adipose Tissue (Combination Product)
Placebo
based on randomization one of the two knees will be treated with a single injection of Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: 12 months
It is a 0 - 100 standardized questionnaire widely used for the evaluation of patients with knee osteoarthrosis. The questionnaire is made by three subscale: Pain (5 questions ranging from 0 - 20), Stiffness (2 questions ranging from 0 - 8) and Function (17 questions ranging from 0 - 68).
次要结局
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Baseline, 1, 3, 6, and 24 months)
- Subjective International Knee Documentation Committee (IKDC - subjective score)(Baseline, 1, 3, 6, 12 and 24 months)
- Objective International Knee Documentation Committee (IKDC-Objective Score)(Baseline, 1, 3, 6, 12 and 24 months)
- Tegner score(Before symptoms onset, at the baseline)
- Patient Acceptable Symptom State (PASS)(Baseline, 1, 3, 6, 12 and 24 months)
- EuroQol Visual Analogue Scale (EQ-VAS)(Baseline, 1, 3, 6, 12 and 24 months)
- Numeric Rating Scale (NRS) - Function(Baseline, 1, 3, 6, 12 and 24 months)
- Numeric Rating Scale (NRS) - Pain(Baseline, 1, 3, 6, 12 and 24 months)
- Kellgren-Lawrence score(baseline and 24 months)
- Magnetic Resonance Imaging(baseline and 12 months)
- overall judgement on the treatment(6, 12 and 24 months)