NCT05925595已完成不适用
A Randomized, Parallel Group, Single Blind Clinical Trial Against Active Comparator to Evaluate the Efficacy and Safety of a Medical Device Made of a Vegetal Biological Matrix for the Treatment of Knee Osteoarthritis.
Bios-Therapy, Physiological Systems for Health S.p.A2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年12月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change at 2 weeks from baseline in WOMAC Pain
研究概览
简要总结
A pre-market randomized, parallel group, single-blind, clinical study with a Medical Device, made of vegetal material, to evaluate the efficacy and safety of one knee injection of the investigational device versus active comparator (Jonexa). The study population will consist of 150 patients diagnosed with primary knee osteoarthrosis. At present, the study is monocentric competitive.
Treatment period for each patient is 6 months.
详细描述
150 patients diagnosed with primary knee osteoarthritis will be enrolled by up to 3 centers.
The study includes 7 visits at the site center.
V-1 (eligibility assessment / screening visit):
- Collection of written informed consent
- Physical examination, including measurement of anthropometric parameters and vital signs (height, weight, diastolic / systolic pressure, heart rate)
- Diagnosed with radiologically confirmed primary osteoarthritis of the knee according to American College of Rheumatology criteria (i.e. one or more osteophytes and a measurable joint space on a plain radiograph taken within 3 months prior to screening).
- Blood tests: glycemia, creatinine, complete blood count with formula, ALT, AST, ALP, calcium, potassium, sodium, C reactive protein, total bilirubin. Urinalysis.
- Advice on daily diary writing to collect the number of concomitant medication before V0
- Recording of adverse events and concomitant therapies in the daily diary
V0 (confirmation of possession of selection criteria):
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
- Single (Participant)
盲法说明
Single blinded (participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent
- •Patient of both sexes over 40 years of age
- •Diagnosis of primary osteoarthritis of the knee according to the criteria of the American College, radiologically confirmed, i.e., one or more osteophytes and a measurable joint space on a standard radiograph taken within 3 months prior to screening.
- •Score ≥2 in the target knee on a Likert scale at WOMAC pain question 1 (i.e. pain while walking on a flat surface) at the V-1 screening visit (to be confirmed at the V0 baseline visit). The target knee is defined as the knee with osteoarthritis in the case of unilateral pathology or the only one with this criterion in the case of bilateral pathology.
- •Severity grade of arthrosis 2 or 3 according to Kellgren & Lawrence classification.
- •Be willing to maintain stable eating habits and lifestyle throughout the study period
排除标准
- •Intake of analgesics, NSAIDs or opioids within 5 days prior to the start of the run-in (i.e. prior to V-1).
- •Body Mass Index (BMI) ≥ 30 kg/m2 .
- •Pregnant women.
- •Intra-articular visco supplementation in the target knee in the preceding 9 months.
- •Cycle of treatment with systemic corticosteroids or intra-articular corticosteroid injection in any joint in the 3 months prior to screening.
- •Symptomatic arthrosis of the contralateral knee with a score ≥3 on a Likert scale to WOMAC pain question 1 (pain while walking on a flat surface) at V-1 (to be confirmed at V0), or severe symptomatic hip arthrosis.
- •Significant deformity: genu varum, ligament laxity or meniscus instability.
- •Presence of autoimmune diseases (excluding chronic autoimmune thyroiditis) or other chronic inflammatory processes (e.g. rheumatoid arthritis, ongoing infections, gout).
- •Ongoing infections.
- •Established or presumed allergy to hyaluronic acid, echinacea or centella.
- •Patients with malignant neoplasms of any kind, or with a history of malignant neoplasms except for patients with a positive history of a malignant neoplasm that has been surgically removed and has not recurred within five years prior to study participation.
- •Abuse of alcohol, narcotics or psychotropic drugs that can alter the state of vigilance and physical perception.
- •Dementia of any kind or other possible causes of progressive deterioration of the mental soundness, or any psychological or physical disability that reduces the ability to take the treatment under study as intended.
- •Inadequate reliability or presence of conditions that may lead to non- compliance/adherence of the patient to the protocol.
- •Previous participation in a clinical study within the last 30 days.
结局指标
主要结局
Change at 2 weeks from baseline in WOMAC Pain
时间窗: [Time Frame: 14 days]
To the patient will be asked to answer 5 questions about the pain experienced in the previous 48 hours, during different activities, using a 5-point Likert scale (0 to 4) for each answer. The total score (minimum 0; maximum 20) is given by the sum of the 5 answers given.
次要结局
- Change from baseline in WOMAC function(Time Frame: 14 days)
- Change in WOMAC pain and function at 4, 12, 24 weeks from baseline(Time Frame: baseline, 4, 12, 24 weeks)
- Adequate global relief of symptoms after treatment(Time Frame: 2, 4, 12, 24 weeks)
- Change in SF-36 at 4, 12, 24 weeks from baseline(Time Frame: baseline, 4, 12, 24 weeks)
研究者
研究点 (2)
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