A SINGLE-BLIND, RANDOMIZED, CONTROLLED STUDY OF A SINGLE, INTRA-ARTICULAR INJECTION OF AUTOLOGOUS MICRO-FRAGMENTED ADIPOSE TISSUE (aMAT) VERSUS (VS) PRP IN PATIENTS WITH OSTEOARTHRITIS (OA) OF THE KNEE
试验速览
- 阶段
- 4 期
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
The study proposes to compare performances and safety of intra-articular injections of aMAT with those of a control group (PRP injections) for the treatment of symptomatic OA of the knee. The end-points will be determined evaluating the performances of the treatment group in terms of improvement of the symptomatology, functional recovery and radiological appearance.
详细描述
The clinical trial is a prospective, randomized, controlled, two-arm, single-blind study, involving 118 patients affected by symptomatic OA of the knee joint. Eligible subjects will be randomly allocated to one of the two treatment groups, with a 1:1 randomization ratio. Respectively, 59 patients treated with a single intra-articular injection of aMAT, and 59 patients treated with a single intra-articular injection of PRP.
The patients enrolled in the study will be treated according to the study protocol and followed after treatment with periodic visits and diagnostic imaging examinations, as Magnetic Resonance Imaging at twelve and twenty-four months follow-up and X-Ray, at three, six, twelve, and twenty-four months of follow-up.
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
- None
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
- •Patients provided written informed consent;
- •Patients aged between 18 and 75 years;
- •Knee symptomatic OA (Kellgren-Lawrence grade 1-4)
- •Failure of conservative treatment for at least 3 months;
- •Patients agreed to actively participate in the rehabilitation protocol and follow-up program;
- •Male or female patients;
- •Women of childbearing age had to use a proven method to prevent pregnancy, before the surgical treatment.
排除标准
- •Patients incapable to understanding and will;
- •Patients participating in previous, concurrent or not, trials (ongoing or completed within three months);
- •Patients surgically treated for the same defect within one year;
- •Patients affected by malignancy;
- •Patients affected by metabolic or thyroid disorders;
- •Patients used to alcohol or drug (medication) abuse;
- •Patients affected by synovitis;
- •Varus or valgus misalignment exceeding 15°;
- •Body Mass Index > 40;
- •Patients with trauma within 6 months pre-operative.
研究组 & 干预措施
platelet-rich plasma (PRP)
single injection of platelet-rich plasma
干预措施: injection of Platelet-rich Plasma (PRP) (Biological)
AUTOLOGOUS MICRO-FRAGMENTED ADIPOSE TISSUE (aMAT)
injection of aMAT obtained with Lipogems® technology.
干预措施: injection of autologous micro-fragmented adipose tissue (aMAT) (Biological)
结局指标
主要结局
Safety
时间窗: Time Frame: 24 months evaluation
Safety of the procedure, documenting characteristics and incidence of adverse events.(AE)
clinical improvement documented with IKDC(International Knee Documentation Committee) score and KOOS (Knee Injury and Osteoarthritis Outcome Score)
时间窗: Time Frame: 6 months evaluation
change in IKDC and KOOS score
次要结局
- stability of the clinical improvement documented with International Knee Documentation Committee (IKDC) score(Time Frame: 6, 24 months evaluation)
- stability of the clinical improvement documented with Knee Injury and Osteoarthritis Outcome Score (KOOS)(Time Frame: 3,6, 12, 24 months evaluation)
研究者
Prof. Marcacci
Principal Investigator
Lipogems International spa