Evaluation of the Effect of the AI500™ SINGLE-DOSE GEL Medical Device in Patients With Reduced Knee Function: 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
- 35
- 试验地点
- 2
- 主要终点
- Clinical performance of AI500™ SINGLE DOSE GEL in improving knee function after 1 week
研究概览
简要总结
Evaluation of the effect of the AI500™ SINGLE-DOSE GEL medical device in patients with reduced knee function
详细描述
The aim of this post-market confirmatory interventional clinical investigation is to evaluate the performance and safety of AI500™ SINGLE-DOSE GEL in patients with reduced knee function.
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
- •Signed patient informed consent form (ICF).
- •Male or Female aged ≥ 18 years at the time of the signature of ICF.
- •Presenting with reduced knee function caused by osteoarthritis flare-ups, meniscal injuries, ligament injuries, inflammation of soft tissues, assessed as 20-45 rating according to the WOMAC function scale.
- •Willingness to follow all study procedures, including attending all site visits, tests, and examinations.
- •Willingness to follow indications.
排除标准
- •Use of analgesics within the 24 hours prior to V
- •Damaged, infected, or ulcerated skin in the area of treatment.
- •Ongoing cutaneous allergies.
- •Serious and chronic pathological skin conditions (i.e., rosacea, psoriasis, vitiligo) or lesions including cancer with/without ongoing antitumor therapy.
- •Patients suffering from muscular dystrophy.
- •Patients presenting with bone fractures or severe injuries (including locked knee).
- •Severely disabled arthritic patients using a wheelchair.
- •Allergy to device components (Sodium hyaluronate; SHPolypeptide- 6; Glycerin; Propylene glycol; Ethylhexylglycerin; Panthenol; PEG-40 hydrogenated castor oil; Sodium hydroxide; Xanthan gum; Phenoxyethanol; Benzoic Acid; Carbomer; Dehydroacetic Acid; Disodium EDTA).
- •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.
- •Patients with both knees affected/damaged.
结局指标
主要结局
Clinical performance of AI500™ SINGLE DOSE GEL in improving knee function after 1 week
时间窗: 1 Week
To evaluate the clinical performance of AI500™ SINGLE DOSE GEL in improving knee function after 1 week of treatment, change from baseline (V0) to week 1 (V3) in Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) Physical Function score will be evaluated. 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.
次要结局
- Clinical performance of AI500™ SINGLE DOSE GEL in improving knee function after 48 hours(2 days)
- Clinical performance of AI500™ SINGLE DOSE GEL in alleviating pain after 24h and 48h of treatment.(2 days)
- Safety and Tolerability of AI500™ SINGLE DOSE GEL(1 week)