Knee OsteoarthritisNCT05412836
Intra-Articular Injection in Moderate Knee Osteoarthritis
A study testing AqueousJoint in people with Knee Osteoarthritis, run by Lipo-Sphere at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- AqueousJoint
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Mar 2022to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- AqueousJoint
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AqueousJointDevice
AqueousJoint is a liposomal boundary lubricant, which coats the cartilage surface and protects it from further damage and degradation.
| Study group | Role | What they receive |
|---|---|---|
| One Treatment Arm | Experimental | Subjects will receive a single intra-articular injection of AqueousJoint. Receives: Device: AqueousJoint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 26 weeks
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start22 Mar 2022
- Primary completion18 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lipo-Sphere
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412836
- Sponsor's protocol ID
- CJO-01
- Status last verified
- Jun 2022
- First submitted
- 27 Feb 2022
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Articular Injection in Moderate Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05412836
- Acronym / sponsor ID
- CJO-01
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lipo-SphereIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 18 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One Treatment Arm | Experimental | Device: AqueousJointSubjects will receive a single intra-articular injection of AqueousJoint. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AqueousJointAqueousJoint is a liposomal boundary lubricant, which coats the cartilage surface and protects it from further damage and degradation. | Device | One Treatment Arm |
Primary outcome
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.
Time frame: 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.
4 secondary outcomes
Change in range of motion from visit 1 (pre-injection) to week 26
Time frame: 26 weeks
Change in life quality from visit 1 (pre-injection) to week 26
Time frame: 26 weeks
Change in functionality from visit 1 (pre-injection) to week 26
Time frame: 26 weeks
Change in pain level and analgesics consumption from visit 1 (pre-injection) to week 26
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AqueousJoint in people with Knee Osteoarthritis, run by Lipo-Sphere at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.