Intra-Articular Injection in Moderate Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Intra-Articular Injection in Moderate Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05412836
• Other study ID #: CJO-01
• Status: Completed
• Phase: N/A
• Start date: March 22, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: June 2022
• Source: Lipo-Sphere
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 30, 2023
• Est. primary completion date: December 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• AqueousJoint
AqueousJoint is a liposomal boundary lubricant, which coats the cartilage surface and protects it from further damage and degradation.

Locations

Country	Name	City	State
Israel	Assuta	Ashdod

Sponsors (1)

Lead Sponsor	Collaborator
Lipo-Sphere

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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