Intra-Articular Injection in Moderate Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Device: AqueousJoint

• Registration Number: NCT05412836
• Lead Sponsor: Lipo-Sphere

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-27
• Study Start: 2022-03-22
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-09
• Primary Completion: 2022-12-18
• Study Completion: 2023-01-30
• Last Update Submitted: 2023-03-05
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One Treatment Arm	AqueousJoint	Subjects will receive a single intra-articular injection of AqueousJoint.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 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

Trial Locations

Locations (1)

Assuta; 🇮🇱 Ashdod, Israel