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Evaluate the Safety and Effectiveness of Mannitol-combined Hyaluronan Supplement in the Treatment of Knee OA

Knee Osteoarthritis Clinical Trial

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.

Clinical Trial Summary

To evaluate the effectiveness and safety of JETKNEE Synovial Fluid Supplement for alleviating pain of knee osteoarthritis (OA).

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05201040
Study type Interventional
Source SciVision Biotech Inc.
Contact Shu-Fen Sun, MD,PhD
Phone 07-3422121
Email sfsun.tw@yahoo.com.tw
Status Recruiting
Phase N/A
Start date November 15, 2021
Completion date December 31, 2022
View Details
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