CTRI/2025/10/096673进行中（未招募）不适用
A Prospective, Single-Center, Non-Randomized, Open-Label Pilot Study to Evaluate the Safety, tolerability and Efficacy of Intra-Articular Injection of Hydrogel OA 2% in for the treatment of Patients with Knee Osteoarthritis.
Allegro NV/SA1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年11月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The occurrence of any device or procedure related (serious) adverse event within 3 months after injection of the device.
研究概览
简要总结
This study aims to evaluate the safety, tolerability and efficacy of one intra articular injection of Hydrogel OA 2% for the symptomatic treatment of KOA between the age group of 35 to 75 years. The trial will be a open-label, single-center, non-randomized, double-arm prospective investigator initiated trial clinical investigation study consisting of 30 participant. Each participant will injected with one intra articular injection of Hydrogel OA 2% at day 1 (treatment visit), there will be a follow up period on one year from treatment visit for each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
入排标准
- 年龄范围
- 35.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults accepting to participate in the study and having signed the written informed consent form before any protocol-specific procedures and able to understand and follow the instructions as described in the protocol.
- •Unilateral symptomatic tibiofemoral KOA confirmed by a standing knee X-ray.
- •In case of bilateral KOA on X-ray only one knee (index knee) presents symptomatic OA pain.
- •Age 35 more than equal to 75 years.
- •BMI 20 more than equal to
- •KOOS Pain score 25 more than equal to
- •Radiological K and L grade II and III from a standing index knee radiograph .
- •Fully ambulatory for functional assessments.
- •Willingness to refrain from taking any pain medication for 48 hours prior intraarticular injection.
- •Female participants must be on effective contraception (pill, patch, ring, diaphragm, implant or intrauterine device), if not surgically sterile (tubal ligation or hysterectomy) or postmenopausal for at least one year.
- •If none of these criteria are met a pregnancy test must be performed at the treatment visit and the result should be negative.
排除标准
- •Bilateral tibiofemoral KOA where the non-index knee presents worse radiological grade of KOA than the index knee.
- •Radiological Kellgren and Lawrence grade 0, I, or IV of the index knee from a standing knee radiograph assessed during the screening visit, using the most recent x-ray taken either immediately or within the past 3 months.
- •Significant clinically assessed varus or valgus deformation of the selected knee side of more than 10 degrees.
- •Extension deficit of the index knee higher than 5 degrees.
- •Bilateral symptomatic tibiofemoral KOA or ipsilateral symptomatic tibiofemoral knee and hip OA.
- •Clinical signs of significant effusion with noticeable swelling and/or inflammation related to severe pain during the treatment visit.
- •Active lymphatic or venous stasis or serious blood disorders (e.g., anemia), bleeding disorders (e.g., hemophilia), blood clots, or blood cancers (e.g., leukemia, lymphoma, and myeloma).
- •Active bacterial infection, resulting in hospitalization and/or requiring intravenous antibiotic treatment.
- •Synovial infection, skin infection or skin diseases in the area of the injection site.
- •History of autoimmune diseases that causes chronic joint pain and inflammation in the knee joint, including rheumatoid arthritis, psoriasis arthritis, juvenile idiopathic arthritis, systemic lupus erythematosus, gout, pseudogout, systemic sclerosis, Sjögren disease, adult-onset still disease.
- •Known or suspected generalized chronic pain disorder.
- •Severe alteration of mobility preventing any functional assessment.
- •Allergy or hypersensitivity to any of the product components of Hydrogel OA 2%.
- •Conditions (orthopedic, rheumatologic, musculoskeletal or inflammatory) causing symptomatic and/or radiating pain in the lower extremities that might interfere with the symptomatic OA knee pain, including hip OA assessed by physical examination by the physician.
- •Symptomatic patellofemoral KOA.
- •Oral corticosteroid therapy in the last 3 months before injection.
- •Severe acute illness within 14 days prior to investigational device administration.
- •Regular/chronic use of opioid drugs for pain control during the last 3 months before screening.
- •Use of opioid drugs within 7 days prior to the treatment visit.
- •Pain Catastrophizing Scale score of 30 or higher than
- •Any intra-articular injection (hyaluronan, hydrogel, soft implant, corticosteroid, platelet-rich plasma, local anesthetic etc.) arthroscopy, surgery in the index knee; or cell-based therapy or an invasive procedure on the index knee in the last 6 months before screening visit.
- •Any investigator-assessed clinically significant condition that may represent a substantial risk to the patient or may have an impact on the study assessments.
- •24.Pregnancy and breastfeeding.
- •25.Legal incapacity or limited legal capacity to consent.
- •Trauma of the index knee in the last 6 months before the treatment visit.
结局指标
主要结局
The occurrence of any device or procedure related (serious) adverse event within 3 months after injection of the device.
时间窗: Day 1 to Day 90
次要结局
- The occurrence of any device or procedure related (serious) adverse event within 12 months after injection of the device.(Day 1 to Day 365)
研究者
Dr Sunil Maheshwari
Prime care Hospital
研究点 (1)
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