Intra-Articular Injection in Moderate Knee Osteoarthritis

Study Overview
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Brief Summary
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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.

Official Title
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Intra-Articular Injection in Moderate Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: AqueousJoint


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One Treatment Arm<br>Subjects will receive a single intra-articular injection of AqueousJoint. | Device: AqueousJoint<br>* AqueousJoint is a liposomal boundary lubricant, which coats the cartilage surface and protects it from further damage and degradation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in range of motion from visit 1 (pre-injection) to week 26 | To measure the effectiveness of the treatment on a range of motion by physical examination | 26 weeks | 
| Change in life quality from visit 1 (pre-injection) to week 26 | To measure the effectiveness of the treatment on life quality by SF12 Questionnaire | 26 weeks | 
| Change in functionality from visit 1 (pre-injection) to week 26 | To measure the effectiveness of the treatment on functionality using PRO: KOOS and Physical activity test - Timed up and go examination | 26 weeks | 
| Change in pain level and analgesics consumption from visit 1 (pre-injection) to week 26 | To measure the effectiveness of the treatment on pain level using VAS and concomitant medication log | 26 weeks |