NCT05412836已完成不适用
Intra-Articular Injection in Moderate Knee Osteoarthritis
Lipo-Sphere1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年3月22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
- 20
- 试验地点
- 1
- 主要终点
- Adverse Events will be evaluated in order to assess the safety of intra-articular injection of Aqueous Joint in osteoarthritic patients up to 26 weeks of follow-up in an open-label clinical study.
研究概览
简要总结
AqueousJoint is a new intra-articular (IA) injectable joint lubricant for patients suffering from knee Osteoarthritis developed by Liposphere LTD.
AqueousJoint is a liposomal boundary lubricant, which coats the cartilage surface and protects it from further damage and degradation. The product goal is restoring cartilage its natural bio-lubrication properties.
AqueousJoint is a surface lubricant that does not change the synovial fluid mechanical characterization but provides hydration protection from cartilage degradation and wear.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
- •Adult male or female at age ≥40 and ≤ 80 years old
- •Pain in the intended study knee with an average VAS score of >5 over the last week prior to visit 1 (pre-injection).
- •Degenerative changes in the intended study knee that can be categorized as grade II-IV Kellgren Lawrence based upon standing posterior-anterior and lateral radiographs of the knee based on X-RAY from up to the last 6 months prior visit 1 (pre-injection).
- •Body Mass Index (BMI) between 18.5 and
- •A negative urine pregnancy test female patient with childbearing potential at Visit 1 prior to intra-articular injection of AqueousJoint.
- •If female, subject must be either postmenopausal, OR permanently surgically sterile OR for women of childbearing potential using at least 2 methods of birth control that are effective from at least 30 days before Visit 1 through visit 26w (26 weeks post injection).
- •Are willing or able to comply with procedures required in this protocol.
排除标准
- •History of significant knee trauma or previous arthroscopic surgery of the intended study knee within the last 3 months preceding screening.
- •Concomitant moderate or large size synovial fluid effusion of the index knee at Screening
- •Wound in the area of the intended study knee
- •Fever signs or symptoms of systemic infection or infection of the intended study knee, on the day before or the day of administration of treatment.
- •Intra-articular injection to the intended study knee within 3 months prior to Screening.
- •Intra-articular injection was administrated during the past 6 weeks
- •Intake of chronic pain medications (especially opioid pain relievers) without an option to pause for the period of the study
- •Pain in any other joints with an average VAS score (active) of >4 at the time of Visit
- •History of Psoriatic Arthritis, Rheumatoid Arthritis or any other inflammatory condition associated with arthritis
- •Known history of a severe allergic reaction
- •Known Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS), Known Hepatitis B or C viral
- •history of clinically significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary or hepatic disease within the last 6 months that, in the Investigator's opinion, would adversely affect the subject's participation in the study.
- •History of cellulitis of the lower extremities, a peripheral vascular disease.
- •History of malignancies during the pat 3 years
- •Life expectancy of less than 12 month
- •Surgery involving the chest, abdomen, pelvis, or lower extremities in the past year
- •Participate in other clinical trials within 3 months prior to the study or concurrent with the study
结局指标
主要结局
Adverse Events will be evaluated in order to assess the safety of intra-articular injection of Aqueous Joint in osteoarthritic patients up to 26 weeks of follow-up in an open-label clinical study.
时间窗: 26 weeks
The safety parameters will include adverse reactions related to the injected material; injection-related side effects consisted of injection-site reaction, erythema, swelling, injection-site pain, and pruritus.
次要结局
- Change in range of motion from visit 1 (pre-injection) to week 26(26 weeks)
- Change in functionality from visit 1 (pre-injection) to week 26(26 weeks)
- Change in life quality from visit 1 (pre-injection) to week 26(26 weeks)
- Change in pain level and analgesics consumption from visit 1 (pre-injection) to week 26(26 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Added Value of Systemic Lidocaine on Postoperative Pain, Opiate Use and Nausea After Knee ArthroscopySurgeryPain, PostoperativeNausea, PostoperativeOpioid UseNCT03599427Algemeen Ziekenhuis Maria Middelares60
已完成
2 期
Intraarticular Injections of the Hip and Knee With Triamcinolone Versus Ketorolac: A Randomized Controlled TrialArthritis KneeArthritis of HipNCT04441112Saint Alphonsus Regional Medical Center120
撤回
不适用
Knee Injections for the Clinical Management of Knee OsteoArthritisKnee OsteoarthritisNCT04595890University of Delaware
撤回
2 期
Intraarticular Injection of InfliximabArthritisNCT00521963HaEmek Medical Center, Israel
已完成
2 期
Multimodal Drug Infiltration in Total Knee Arthroplasty: Is Posterior Capsular Infiltration Worth the Risk?Osteoarthritis, KneeNCT02860949Thammasat University90