Randomized Controlled Single-Blind Multi-Centre Evaluation of the Safety and Performance of an Injection of Hydrogel OA 2% in Subjects With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 226
- 试验地点
- 7
- 主要终点
- Safety of Hydrogel OA 2% in subjects with symptomatic KOA
研究概览
简要总结
The goal of this clinical study is to learn if Hydrogel OA 2% injection is safe and whether it works to improve symptoms of diagnosed knee osteoarthritis in adults when compared to Hyaluronic Acid (Durolane), a treatment that is currently often used for treatment of knee osteoarthritis. The main question it aims to answer is:
- How many study participants will experience side effects related to Hydrogel OA 2% during the study when compared to Hyaluronic Acid (Durolane)?
All study participants will receive either one Hydrogel OA 2% or Hyaluronic Acid (Durolane) injection in their knee during the clinical study. Study participants will not know which treatment they have received. Study participants will also receive a call from the researchers and visit the clinic three times to report whether they have experienced any side effects, and complete a questionnaire that will ask questions on whether their symptoms have improved since they received an injection.
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)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 (indexed knee) presents symptomatic OA pain.
- •Age 35 ≤ 75 years.
- •Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain score 25-
- •Radiological Kellgren and Lawrence (K&L) grade II and III from a standing knee radiograph with minimum joint space of 1 mm in the study knee.
- •Fully ambulatory for functional assessments.
- •Willingness to refrain from taking any pain medication for 48 hours prior to each study visit.
- •Female subjects 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. Females must show a negative pregnancy test at the treatment visit.
排除标准
- •Bilateral tibiofemoral KOA where the non-symptomatic knee presents worse radiological grade of KOA.
- •Radiological K&L grade 0, I, or IV 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 of higher than 5 degrees.
- •Bilateral symptomatic tibiofemoral KOA or a combined unilateral symptomatic tibiofemoral knee and hip OA.
- •Clinical signs of significant effusion with noticeable swelling and/or inflammation related severe pain during the treatment visit.
- •Evidence of 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 infections or any skin diseases in the area of the injection site.
- •History of autoimmune diseases that cause 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's disease, adult-onset still's 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.
- •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 knee OA.
- •Oral corticotherapy ≥4 mg/day (in prednisone equivalent) in the last 3 months before injection.
- •Severe acute illness within 14 days prior to investigational device administration.
- •Any intra-articular injection (hyaluronan, hydrogel, soft implant, corticosteroid, platelet-rich plasma, local anesthetic etc.) arthroscopy, surgery in the treated knee; or cell-based therapy or an invasive procedure on the treated knee in the last 6 months before screening visit.
- •Anticipated need for any surgical or other invasive procedure throughout the course of the clinical investigation, including prosthesis in the treatment knee, any concurrent OA treatments including alternative treatments (e.g., acupuncture, ultrasound, magnetic resonance etc.).
- •Any investigator-assessed clinically significant condition that may represent a substantial risk to the patient or may have an impact on the study assessments.
- •Participation in another clinical trial in the last 3 months before injection.
- •Pregnancy and breastfeeding.
- •Legal incapacity or limited legal capacity to consent.
- •Trauma of the treatment knee in the last 6 months before the treatment visit.
研究组 & 干预措施
Hydrogel OA 2%
treatment arm
干预措施: Hydrogel OA 2% (Device)
Hyaluronic Acid (Durolane)
control arm
干预措施: Hyaluronic Acid (Durolane) (Device)
结局指标
主要结局
Safety of Hydrogel OA 2% in subjects with symptomatic KOA
时间窗: From the treatment to the end of the follow up at 26 weeks
The primary aim of this study is to test the safety of Hydrogel OA 2% in patients with symptomatic KOA. Specifically, the aim is to demonstrate that the proportion of patients experiencing Hydrogel OA 2%-related AEs is equal to the the proportion of patients experiencing Durolane-related AEs .
次要结局
- The improvement in the Knee Injury and Osteoarthritis Outcome Score (KOOS) 'Pain' score at 26 weeks after treatment(From the treatment to the end of the follow up at 26 weeks)