Knee OsteoarthritisNCT05201040
Evaluate the Safety and Effectiveness of Mannitol-combined Hyaluronan Supplement in the Treatment of Knee OA
A study testing JETKNEE Synovial Fluid Supplement and Normal saline in people with Knee Osteoarthritis and Hyaluronic Acid, run by SciVision Biotech Inc. at 2 sites in Taiwan.
Trial summary
To evaluate the effectiveness and safety of JETKNEE Synovial Fluid Supplement for alleviating pain of knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Knee Osteoarthritis, Hyaluronic Acid
- What is being tested?
- JETKNEE Synovial Fluid Supplement and Normal saline
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 2 sitesTaiwan
- Study dates
- 15 Nov 2021to 15 Jun 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45 to 85 years of male or female.
- Meet the ACR diagnostic criteria, the target knee is confirmed with OA by radiographic images and Kellgren \&Lawrence (K-L) score of 2 to 3；
- Patients who still suffer from OA pain after receiving traditional non-drug therapy or general analgesic therapy within 6 months before the start of the study；
- The VAS pain score of target knee must be at least 3 cm within 1 week before the screening and if the other side of knee has OA at the same time, the VAS pain score should be less than 3 cm；
- Subject who has ability to understand the study purpose, comply with the study requirements, willing to stop all pain medications and physical therapy to the knees during the study and sign informed consent form (ICF).
Who cannot join
- The hip or ankle joints are diagnosed with OA, pain, or deformity；
- K-L score of 4 by radiographic image evaluation；
- The target knee has symptoms such as infection, redness, and swelling at the screening period and before treatment ；
- The target knee has received hyaluronic acid treatment within 6 months before included in the study；
- The target side has received lower limb surgery or knee operation with accompanied complications and significant mobility impairment within 6 months before the start of the study；
- The target knee has received treatments such as steroid injection, arthrocentesis or arthroscopic surgery within 3 months before screening；
Show all 12Show fewer
- Patient with autoimmune disease (such as autoimmune collagenopathy, rheumatoid arthritis), malignant tumors, coagulation disorder, heart diseases, mental diseases…etc. which may cause higher risk to patients during participation in the study；
- Receiving orthopedic-related treatments which may affect the evaluation of the study；
- With history of hypersensitivity or allergy to hyaluronic acid or any component of the device; With history of hypersensitivity or allergy to Gram-positive bacteria or Streptococcus proteins；
- Pregnant, planning pregnancy or in breastfeeding females during the study period；
- Subject who cannot cooperate with the follow- ups；
- Other circumstances which judged to be unsuitable for participating in the study by the investigator.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Kaohsiung Municipal Siaogang Hospital
Kaohsiung City
Kaohsiung Veterans General Hospital
Kaohsiung City
About this study
Official title: A Prospective, Randomized, Evaluator/Subject-blinded, Double-Center, Controlled Clinical Study: Evaluate the Safety and Effectiveness of Mannitol-combined Hyaluronan Supplement in the Treatment of Knee Osteoarthritis.
To evaluate the effectiveness and safety of JETKNEE Synovial Fluid Supplement for alleviating pain of knee osteoarthritis (OA).
Read the detailed description
The medical device is a bioabsorbable, extensible, crosslinked, 2% hyaluronic acid gel using micro-organism fermentation sourced hyaluronic acid as a major component and add mannitol is added which can inhibit the degradation of hyaluronate acid by free radicals to prolong the therapeutic effect. The medical device is injected into the articular cavity to protect joint tissue, increase joint lubricity, inhibit degradation of cartilage and promote the metabolism of cartilage by infiltrating degenerated cartilage. In addition, the medical device can penetrate the synovial tissue to inhibit inflammation and degradation. It also inhibits pain mediators in the synovium to achieve the pain inhibition. This study is to evaluate the effectiveness and safety of JETKNEE Synovial Fluid Supplement for alleviating pain of knee OA 6 months after single injection.
- Conditions
- Knee Osteoarthritis, Hyaluronic Acid
- Being tested
- JETKNEE Synovial Fluid Supplement, Normal saline
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JETKNEE Synovial Fluid SupplementDevice
2mL of JETKNEE Synovial Fluid Supplement
Normal salineDevice
2mL of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Mannitol-combined Hyaluronic acid | Experimental | 2.0mL/syringe for one treatment Receives: Device: JETKNEE Synovial Fluid Supplement |
| Normal saline | Placebo comparator | 2.0mL for one treatment Receives: Device: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain score of Visual Analog Scale (VAS) of target knee at 6 months post-treatment.
The pain score of Visual Analog Scale (VAS) of target knee at 6 months post-treatment.
Based on the patient described pain intensity as 0 to 10 score, a higher score indicates greater pain intensity.
Measured: 6 months post-treatment
Secondary outcomes (11)
The pain score of VAS of target knee at baseline, 2 weeks, 1 month, and 3 months post-treatment
The pain score of VAS of target knee at baseline, 2 weeks, 1 month, and 3 months post-treatment.
Based on the patient described pain intensity as 0 to 10 score, a higher score indicates greater pain intensity.
Measured: baseline, 2 weeks, 1 month, and 3 months post-treatment
The average score of Western Ontario and McMaster Universities (WOMAC) in pain section of the target knee at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment
The average score of Western Ontario and McMaster Universities (WOMAC) in pain section of the target knee at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment The WOMAC measures five items for pain (score range 0-20).Higher scores indicate worse pain, stiffness, and functional limitations.
Measured: baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment
The average score of WOMAC in stiffness section of target knee at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment
The average score of WOMAC in stiffness section of target knee at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment.
The WOMAC measures two for stiffness (score range 0-8).Higher scores indicate worse pain, stiffness, and functional limitations.
Measured: baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment
The average score of WOMAC in function section of target knee at baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment
The average score of WOMAC in function section of target knee at baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment.
The WOMAC measures 17 for functional limitation (score range 0-68).Higher scores indicate worse pain, stiffness, and functional limitations.
Measured: baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment
The average total score of WOMAC of the target knee at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment
The average total score of WOMAC of the target knee at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment.
The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).Higher scores indicate worse pain, stiffness, and functional limitations.
Measured: baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment
The average total score of Lequesne's Index (LI) of target knee at baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment
The average total score of Lequesne's Index (LI) of target knee at baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment
Measured: baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment
The thickness of femoral Intercondylar cartilage of the target knee by ultrasound at baseline, 1 month, 3 months and 6 months post-treatment
The thickness of femoral Intercondylar cartilage of the target knee by ultrasound at baseline, 1 month, 3 months and 6 months post-treatment
Measured: baseline and1 month, 3 months and 6 months post-treatment
The quadriceps thickness of the target knee by ultrasound at baseline and 1 month, 3 months and 6 months post-treatment
The quadriceps thickness of the target knee by ultrasound at baseline and 1 month, 3 months and 6 months post-treatment
Measured: baseline and 1 month, 3 months and 6 months post-treatment
The grade of cartilage of target knee by ultrasound at baseline, 1 month, 3 months and 6 months post-treatment
The grade of cartilage of target knee by ultrasound at baseline, 1 month, 3 months and 6 months post-treatment
Measured: baseline, 1 month, 3 months and 6 months post-treatment
Holding time of Single-leg Stance Test (SLS) on target knee at baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment
Holding time of Single-leg Stance Test (SLS) on target knee at baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment
Measured: baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment
Subject self-evaluating satisfaction at 2 weeks, 1 month, 3 months and 6 months post-treatment
Subject self-evaluating satisfaction at 2 weeks, 1 month, 3 months and 6 months post-treatment
Measured: 2 weeks, 1 month, 3 months and 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start15 Nov 2021
- Primary completion15 Jun 2023
- Study completion15 Jun 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- SciVision Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201040
- Sponsor's protocol ID
- RDCT-VSJK
- Status last verified
- May 2023
- First submitted
- 5 Jan 2022
- Last updated
- 13 Sep 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 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Evaluator/Subject-blinded, Double-Center, Controlled Clinical Study: Evaluate the Safety and Effectiveness of Mannitol-combined Hyaluronan Supplement in the Treatment of Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT05201040
- Acronym / sponsor ID
- RDCT-VSJK
- Conditions
- Knee Osteoarthritis, Hyaluronic Acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- SciVision Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 21 Jan 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.
To evaluate the effectiveness and safety of JETKNEE Synovial Fluid Supplement for alleviating pain of knee osteoarthritis (OA).
Detailed description
The medical device is a bioabsorbable, extensible, crosslinked, 2% hyaluronic acid gel using micro-organism fermentation sourced hyaluronic acid as a major component and add mannitol is added which can inhibit the degradation of hyaluronate acid by free radicals to prolong the therapeutic effect. The medical device is injected into the articular cavity to protect joint tissue, increase joint lubricity, inhibit degradation of cartilage and promote the metabolism of cartilage by infiltrating degenerated cartilage. In addition, the medical device can penetrate the synovial tissue to inhibit inflammation and degradation. It also inhibits pain mediators in the synovium to achieve the pain inhibition. This study is to evaluate the effectiveness and safety of JETKNEE Synovial Fluid Supplement for alleviating pain of knee OA 6 months after single injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mannitol-combined Hyaluronic acid | Experimental | Device: JETKNEE Synovial Fluid Supplement2.0mL/syringe for one treatment |
| Normal saline | Placebo comparator | Device: Normal saline2.0mL for one treatment |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 45 to 85 years of male or female.
- Meet the ACR diagnostic criteria, the target knee is confirmed with OA by radiographic images and Kellgren \&Lawrence (K-L) score of 2 to 3；
- Patients who still suffer from OA pain after receiving traditional non-drug therapy or general analgesic therapy within 6 months before the start of the study；
- The VAS pain score of target knee must be at least 3 cm within 1 week before the screening and if the other side of knee has OA at the same time, the VAS pain score should be less than 3 cm；
- Subject who has ability to understand the study purpose, comply with the study requirements, willing to stop all pain medications and physical therapy to the knees during the study and sign informed consent form (ICF).
Key exclusion criteria (12 listed)
- The hip or ankle joints are diagnosed with OA, pain, or deformity；
- K-L score of 4 by radiographic image evaluation；
- The target knee has symptoms such as infection, redness, and swelling at the screening period and before treatment ；
- The target knee has received hyaluronic acid treatment within 6 months before included in the study；
- The target side has received lower limb surgery or knee operation with accompanied complications and significant mobility impairment within 6 months before the start of the study；
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 |
|---|---|---|
| JETKNEE Synovial Fluid Supplement2mL of JETKNEE Synovial Fluid Supplement | Device | Mannitol-combined Hyaluronic acid |
| Normal saline2mL of normal saline | Device | Normal saline |
Primary outcome
The pain score of Visual Analog Scale (VAS) of target knee at 6 months post-treatment.
Time frame: 6 months post-treatment
The pain score of Visual Analog Scale (VAS) of target knee at 6 months post-treatment. Based on the patient described pain intensity as 0 to 10 score, a higher score indicates greater pain intensity.
11 secondary outcomes
The pain score of VAS of target knee at baseline, 2 weeks, 1 month, and 3 months post-treatment
Time frame: baseline, 2 weeks, 1 month, and 3 months post-treatment
The average score of Western Ontario and McMaster Universities (WOMAC) in pain section of the target knee at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment
Time frame: baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment
The average score of WOMAC in stiffness section of target knee at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment
Time frame: baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment
The average score of WOMAC in function section of target knee at baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment
Time frame: baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment
The average total score of WOMAC of the target knee at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment
Time frame: baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment
The average total score of Lequesne's Index (LI) of target knee at baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment
Time frame: baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment
The thickness of femoral Intercondylar cartilage of the target knee by ultrasound at baseline, 1 month, 3 months and 6 months post-treatment
Time frame: baseline and1 month, 3 months and 6 months post-treatment
The quadriceps thickness of the target knee by ultrasound at baseline and 1 month, 3 months and 6 months post-treatment
Time frame: baseline and 1 month, 3 months and 6 months post-treatment
The grade of cartilage of target knee by ultrasound at baseline, 1 month, 3 months and 6 months post-treatment
Time frame: baseline, 1 month, 3 months and 6 months post-treatment
Holding time of Single-leg Stance Test (SLS) on target knee at baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment
Time frame: baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment
Subject self-evaluating satisfaction at 2 weeks, 1 month, 3 months and 6 months post-treatment
Time frame: 2 weeks, 1 month, 3 months and 6 months post-treatment
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 13 Sep 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JETKNEE Synovial Fluid Supplement and Normal saline in people with Knee Osteoarthritis and Hyaluronic Acid, run by SciVision Biotech Inc. at 2 sites in Taiwan.
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 5 inclusion and 12 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 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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. Some participants in this study may receive a placebo. 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?
The pain score of Visual Analog Scale (VAS) of target knee at 6 months post-treatment. (time frame: 6 months post-treatment). 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 13 Sep 2023.