Evaluation of the Effect of the "CR500 SINGLE-DOSE GEL" Medical Device in Patients With Knee Osteoarthritis (KOA): a Post-market Confirmatory Interventional, Single Arm Clinical Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- OA evaluation, measured by Lequesne Knee Index (LKI)
研究概览
简要总结
Single arm clinical investigation, post-market confirmatory interventional to assess performance, safety and tolerability of "CR500 SINGLE-DOSE GEL" medical device in patients with knee osteoarthritis (KOA).
详细描述
Subjects 26-83 years old will receive CR500 SINGLE-DOSE GEL given for the treatment of osteoarthritis of the knee over a 4-week time period. The primary objective of the study is to evaluate the effect of CR500 SINGLE-DOSE GEL in the treatment of KOA.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female, aged ≥18 years at the time of the signature of ICF (Informed Consent Form).
- •Patients with a diagnosis of primary or secondary KOA affecting only one knee (monolateral KOA) of "mild" (score 1 - 4) or "moderate" (score 5 - 7) severity according to the LKI score.
- •Willing to follow all study procedures, including attending all site visits, tests and examinations.
- •Willing to participate in the study and sign the ICF.
排除标准
- •Osteoarthritis (OA) in both knees (bilateral KOA).
- •Other - different - clinical conditions of the knee.
- •Infective or inflammatory processes near the area of treatment.
- •Damaged skin in the area of treatment.
- •Ongoing cutaneous allergies.
- •Serious and chronical pathological skin conditions (i.e. rosacea, psoriasis, vitiligo) including diagnosticated cancer with/without ongoing antitumor therapy.
- •Allergy to device components (Sodium hyaluronate; Synthetic Human (SH)-Polypeptide-85; SH-Polypeptide-93; Glycerin; Propylene glycol; Ethylhexylglycerin; Panthenol; Polyethylene Glycol (PEG)-40 hydrogenated castor oil; Sodium hydroxide; Xanthan gum; Phenoxyethanol; Benzoic Acid; Carbomer; Dehydroacetic Acid; Disodium EDTA).
- •Any other systemic or local therapy for the treatment of KOA.
- •Any other systemic or local therapy (e.g. NSAIDs, corticosteroids) for the treatment of other inflammatory diseases (e.g. dermatitis, acute or chronic bronchitis, gastroenteritis, etc.) or painful states (e.g. headache, dental abscess, etc.) that may interfere with the clinical course of KOA under treatment with the medical device CR
- •Immune system illnesses.
- •Uncontrolled systemic diseases.
- •Known drug and/or alcohol abuse.
- •Mental incapacity that precludes adequate understanding or cooperation.
- •Participation in another investigational study.
- •Pregnancy* or breastfeeding.
研究组 & 干预措施
CR500 single-dose gel
Interventional study on CR500 1.5 mL will be topically administered twice a week for four weeks
干预措施: CR 500™ SINGLE-DOSE GEL (Device)
结局指标
主要结局
OA evaluation, measured by Lequesne Knee Index (LKI)
时间窗: 4 weeks
The primary efficacy endpoint of the study will be the evaluation of the clinical performance of the CR 500™, used as intended in patients affected by KOA, in variation of symptoms related to the physiological degeneration of cartilage typical of osteoarthritic processes, in terms of difference in LKI score between the end study visit and baseline visit. Lequesne Knee Index Score: minimum index score: 0 maximum index score: 24 0 means none OA \>= means extremely severe OA
次要结局
- Symptoms Variation in terms of Lequesne Knee Index (LKI) score(4 weeks)
- Product tolerability and patient satisfaction as assessed by a questionnaire using a five-points Likert scale(4 weeks)
- Evaluation of the status of the cartilage by quantification of type II collagen propeptide (CPII) quantification(4 weeks)
- Lequesne Knee Index (LKI) Score(4 weeks)
- Cluster of Subjective Symptoms evaluated by Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire(4 weeks)
- Evaluation of the status of the cartilage degradation by quantification of C-terminal telopeptide of type II collagen (CTX-II)(4 weeks)
- Evaluation of the status of the cartilage degradation by quantification of neoepitope of type II collagen (C2C)(4 weeks)
- Evaluation of the status of the cartilage by quantification of hyaluronic acid (HA) quantification(4 weeks)
- Number of participants with treatment-related adverse event as assessed by a questionnaire.(4 weeks)
- Lequesne Knee Index (LKI) Subscore(4 weeks)
- Evaluation of the inflammatory status of the knee joint by quantification of tumour necrosis factor (TNF) quantification(4 weeks)
- Evaluation of the macrophages infiltration in the knee joint by quantification of Cluster of Differentiation 206 (CD206)(4 weeks)
- Evaluation of the macrophages infiltration in the knee joint by quantification of Cluster of Differentiation 11c (CD11c)(4 weeks)