Knee Osteoarthritis
Conditions
Brief 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.
Interventions
DEVICEAqueousJoint
AqueousJoint is a liposomal boundary lubricant, which coats the cartilage surface and protects it from further damage and degradation.
Sponsors
Lipo-Sphere
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in range of motion from visit 1 (pre-injection) to week 26 | 26 weeks | To measure the effectiveness of the treatment on a range of motion by physical examination |
| Change in life quality from visit 1 (pre-injection) to week 26 | 26 weeks | To measure the effectiveness of the treatment on life quality by SF12 Questionnaire |
| Change in functionality from visit 1 (pre-injection) to week 26 | 26 weeks | To measure the effectiveness of the treatment on functionality using PRO: KOOS and Physical activity test - Timed up and go examination |
| Change in pain level and analgesics consumption from visit 1 (pre-injection) to week 26 | 26 weeks | To measure the effectiveness of the treatment on pain level using VAS and concomitant medication log |
Countries
Israel
Outcome results
None listed