Intra-Articular Injection in Moderate Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
AqueousJoint
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
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
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
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
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.
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
No
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
No
Learn more about this trial
Intra-Articular Injection in Moderate Knee Osteoarthritis
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