Comparison of the Efficacy of Intra-articular Injection of Human Amniotic Suspension Allograft and Platelet-rich Plasma in the Treatment of Knee Osteoarthritis: A Prospective, Double-blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 主要终点
- Change of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) between baseline, 1 week, and 1 ,3 ,6 ,12 months.
研究概览
简要总结
A double-blind, randomized controlled trial designed to evaluate the symptomatic modulating efficacy of amniotic suspension allograft (ASA) in comparison to platelet-rich plasma (PRP), hyaluronic acid (HA) and normal saline (NS) in the injection treatment of knee osteoarthritis. The hypothesis is that ASA would provide the greatest functional improvement.
详细描述
At least 150 subjects with osteoarthritic knee will be recruited and computer randomized 1:1:1:1 to single injection of ASA (40mg), ASA (20mg), PRP + HA, and NS groups. Both subjects and evaluaters were blinded to allocations. Functional and radiologic outcomes were measured at baseline, and 1 week, 1, 3, 6, 12 months postinjection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 80 years
- •Ability to provide informed consent
- •Unilateral or bilateral knee VAS pain score ≥ 4 of 10 (worst possible pain) for more than 4 months
- •Diagnosis of OA Kellgren-Lawrence I-III by radiography (triple-film of bilateral lower limb, standard knee anterior-posterior view in full extension, lateral view in 30-degrees flexion, and 45°Merchant views)
- •No prior PRP injection of knee
- •No prior surgical procedure of the participating knee
- •BMI<40 kg/m2
排除标准
- •Lawrence stage IV
- •Major axial deviation (varus> 5°, valgus > 5°)
- •Any concomitant symptomatic knee disorder (i.e. ligamentous/ meniscal injury)
- •Systemic inflammatory arthropathy
- •Hematologic diseases
- •Severe cardiovascular disease
- •Neurological disorders
- •Active infection
- •Immuno-compromised
- •Therapy with anticoagulants or antiaggregants
- •Use of NSAIDs and/or chondroprotective supplements, such as glucosamines and chondroitin sulfates, within 7 days prior to trial
- •Recent intra-articular injection of corticosteroids (within 30 days)
- •Prior treatment with HA in past 6 monthsHb< 11 g/dL
- •Platelet count < 150,000/mm3
结局指标
主要结局
Change of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) between baseline, 1 week, and 1 ,3 ,6 ,12 months.
时间窗: Baseline, 1 week, 1,3,6,12 months
WOMAC is a self-administered questionnaire consisting of 24 items divided into 3 subscales:(1) Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright(2) Stiffness (2 items): after first waking and later in the day(3) Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic dutiesThe test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
次要结局
- Change of the International Knee Documentation Committee (IKDC Questionnaire) between baseline, 1 week, and 1 ,3 ,6 ,12 months.(Baseline, 1 week, 1,3,6,12 months)
研究者
Yin Ming, Huang
Chief resident of Orthopedic.
Kaohsiung Veterans General Hospital.