intra-articular injection in moderate knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: 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.


Eligibility criteria:
inclusion criteria: * 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 35. * 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. exclusion criteria: * 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 1. * 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