An interventional study of JETKNEE Synovial Fluid Supplement and Normal saline in Knee Osteoarthritis and Hyaluronic Acid, sponsored by SciVision Biotech Inc.. Completed at 2 sites in Taiwan. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by SciVision Biotech Inc. · Not applicable, Interventional, and Treatment
To evaluate the effectiveness and safety of JETKNEE Synovial Fluid Supplement for alleviating pain of knee osteoarthritis (OA).
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 132 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →SciVision Biotech Inc. is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
2.0mL/syringe for one treatment
Device: JETKNEE Synovial Fluid Supplement
2.0mL for one treatment
Device: Normal saline
2mL of JETKNEE Synovial Fluid Supplement
2mL of normal saline
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.
Time frame: 6 months post-treatment
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.
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
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.
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
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.
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
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.
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
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.
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
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
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
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
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
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
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
Plan to share: No
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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SciVision Biotech Inc.