SVF in Infiltrative Therapy for Ankle Osteoarthritis: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- AOS (Ankle Osteoarthritis Scale)
研究概览
简要总结
The aim of this pilot study is to analyze the effect of SVF injection produced by adipose tissue processing, in terms of clinical improvement, in patients with moderate to severe (stage 1-3) ankle osteoarthritis. Evaluation will be performed by administering pre-operative and post-operative clinical assessment questionnaires.
Patients will be followed-up with a pre-operative evaluation and post-operative evaluations at 30 days, 3-6-12, and 24 months after application.
详细描述
30 patients with moderate to severe ankle osteoarthritis (grade 1-3 according to Giannini's classification) will be included in this pilot study, in which patients will be treated with single injection of Stromal Vascular Fraction - SVF ,obtained by processing the patient's abdominal adipose tissue. All patients will be examined with a baseline clinical visit. For obtaining SVF, will be carried out a routinely performed procedure aimed at obtaining a small amount of adipose tissue from all patients. Subsequently, patients will be followed up with clinical evaluation at 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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from moderate to severe unilateral ankle arthrosis (grade 1-3 according to Giannini's classification);
- •Patients who gave written informed consent to participate in the study;
- •.Patients with MRI examination showing absence of osteochondral lesion;
- •Patients who have given their willingness to come to the Institute for follow-up visits
排除标准
- •Patients with BMI>30 kg/m2
- •Patients with Rheumatoid Arthritis
- •Patients with chronic inflammatory joint disease;
- •Patients with acute or chronic infections;
- •Patients with pre-existing abnormalities of gait kinematics (amputations, neuro-muscular diseases, poliomyelitis, hip dysplasia);
- •Patients with severe knee arthrosis (Kellgren-Lawrence>3);
- •Patients with ankle deformities greater than 8°;
- •Patients with pain on other joints of the foot;
- •Patients with severe postural instability;
- •Patients with cognitive deficits;
- •Patients with concomitant neurological pathologies
研究组 & 干预措施
SVF injection
All patients with ankle osteoarthritis will be treated with a single injection of SVF, obtained from the patient's abdominal adipose tissue. All patients will be examined with a baseline clinical visit and will be followed-up with clinical evaluation at 1, 3, 6, 12 and 24 months.
干预措施: SVF injection (Procedure)
结局指标
主要结局
AOS (Ankle Osteoarthritis Scale)
时间窗: Baseline to 24 months
AOS is a score divided into 2 subscales, each with 9 questions. The first section assesses pain, while the other assesses ankle function. The answers consist of a rating on a 100-mm-long horizontal visual analog scale (from "no pain" to "worst pain imaginable" for pain section, and "no limitation" and "extremely limited" for function section). The highest possible value of the score is 100 (worst score) and the lowest (best score) is 0.
次要结局
- VAS-pain (Visual Analogue Scale)(baseline, 1,3,6,12,24 months)
- EQ-VAS(baseline, 1,3,6,12,24 months)
- Final treatment opinion(baseline, 1,3,6,12,24 months)
- AOFAS (The American Orthopedic Foot and Ankle Score):(baseline, 1,3,6,12,24 months)
- Range Of Motion (ROM)(baseline, 1,3,6,12,24 months)
- SF-12 (12-Item Short Form Survey):(baseline, 1,3,6,12,24 months)
- EQ-5D (EuroQoL) Current Health Assessment(baseline, 1,3,6,12,24 months)
- Patient Acceptable Symptom State (PASS):(baseline, 1,3,6,12,24 months)