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Intra-Articular Injection in Moderate Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

AqueousJoint

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Assuta

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

One Treatment Arm

Arm Description

Subjects will receive a single intra-articular injection of AqueousJoint.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

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

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

Full Information

NCT ID

NCT05412836

First Posted

February 27, 2022

Last Updated

March 5, 2023

Sponsor

Lipo-Sphere

1. Study Identification

Unique Protocol Identification Number

NCT05412836

Brief Title

Intra-Articular Injection in Moderate Knee Osteoarthritis

Official Title

Intra-Articular Injection in Moderate Knee Osteoarthritis

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

March 22, 2022 (Actual)

Primary Completion Date

December 18, 2022 (Actual)

Study Completion Date

January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lipo-Sphere

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

One Treatment Arm

Arm Type

Experimental

Arm Description

Subjects will receive a single intra-articular injection of AqueousJoint.

Intervention Type

Device

Intervention Name(s)

AqueousJoint

Intervention Description

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

Primary Outcome Measure Information:

Title

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.

Description

Time Frame

26 weeks

Secondary Outcome Measure Information:

Title

Change in range of motion from visit 1 (pre-injection) to week 26

Description

To measure the effectiveness of the treatment on a range of motion by physical examination

Time Frame

26 weeks

Title

Change in life quality from visit 1 (pre-injection) to week 26

Description

To measure the effectiveness of the treatment on life quality by SF12 Questionnaire

Time Frame

26 weeks

Title

Change in functionality from visit 1 (pre-injection) to week 26

Description

To measure the effectiveness of the treatment on functionality using PRO: KOOS and Physical activity test - Timed up and go examination

Time Frame

26 weeks

Title

Change in pain level and analgesics consumption from visit 1 (pre-injection) to week 26

Description

To measure the effectiveness of the treatment on pain level using VAS and concomitant medication log

Time Frame

26 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Assuta

City

Ashdod

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

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Intra-Articular Injection in Moderate Knee Osteoarthritis

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