Comparative Assessment of Viscosupplementation With Polynucleotides and Hyaluronic Acid to Viscosupplementation With Hyaluronic Acid in the Treatment of Osteoarthritis of the Knee. Randomized, Double-blind, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
研究概览
简要总结
The purpose of the study is to assess the validity of the polynucleotide within the intra articular treatment of osteoarthritis of the knee, comparing it with that of hyaluronic acid, the most commonly used.
详细描述
This study is double-blind, controlled, randomized.The aim of the study is to evaluate the efficacy, safety and tolerability of polynucleotides and hyaluronic acid gel (PNHA, class III medical device) for intra-articular infiltration in treating pain in osteoarthritis (OA) patients knee.
This study will involve patients with osteoarthritis who comply with the inclusion and exclusion criteria. One hundred patients between the ages of 45 and 70 will be enrolled in the study and randomized to receive one of the following treatment groups:
Group A) Polynucleotides and Hyaluronic Acid (PNHA) Group B) Hyaluronic Acid (HA) The treatment will be administered through intra-articular infiltration, a weekly infiltration in the affected knee, for a total of 3 infiltrations (T0, T1 and T2).
The use of non-steroidal anti-inflammatory drugs (NSAIDs) was permitted, but the use of paracetamol 1 cp 1000 mg every 12 hours, or Meloxicam 15 mg a tablet after meals every 12 hours, was recommended.
In case of grug taking: the number of days when the patient used NSAIDs, the commercial name and the NSAID dosage used were reported in the CRF.
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, Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 50 and 75 years
- •Patients informed consent
- •Knee OA (Osteoarthritis) (ACR classification) with a Kellgren Laurence from 1 to 4
- •Knee pain from arisen at least 2 months
- •BMI lower than 40
排除标准
- •Pregnancy or lactation
- •Severe systemic disorders
- •History of drug abuse or alcoholism
- •Hypersensibility to Hyaluronic acid or Polynucleotide
- •No previous intra articular infiltration (from 3 months)
- •No steroidal or anticoagulant systemic therapy from one month
- •Knee articular deformity
- •Patients affected by rheumatoid arthritis or other inflammatory articular pathologies and hematological disorders
- •Focal skin lesion in the anatomical site of injections
研究组 & 干预措施
Polynucleotide - PNHA - Newart
50 patients will be enrolled and treated with three weekly injections of polynucleotide plus hyaluronic acid
干预措施: Polynucleotide - PNHA - Newart (Device)
Hyaluronic acid - HA - Ialart
50 patients will be enrolled and treated with three weekly injections of hyaluronic acid
干预措施: Hyaluronic acid - HA - Ialart (Device)
结局指标
主要结局
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
时间窗: 6 months
The WOMAC is a self-administered questionnaire consisting of 24 items divided into 3 subscales Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day 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 duties. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
次要结局
- Synovial fluid analysis(3 weeks)
- KSS (Knee society score)(6 months)
- Growth factor contained in synovial fluid determinations(3 weeks)
研究者
Carubbi
MD
Istituto Ortopedico Rizzoli