Important Safety Information for HYAJOINT Plus

Please Refer to Instruction For Use (IFU)

You should not receive HYAJOINT Plus if you have an infection in your knee or in the skin around your knee. Before receiving HYAJOINT Plus injection, tell your health professional if you have had an allergic symptoms before, such as flushing of the face, scratchy throat, pain or tightness in the chest, rash, itching or hives to any hyaluronic acid based products. The injection of HYAJOINT Plus can only be performed by a qualified health care providers. HYAJOINT Plus has not been tested to show pain relief in joints other than the knee.

If you are taking blood thinners such as aspirin or warfarin, you may need to stop them for a few days before your knee injection. You should always discuss this with your doctor first.

Possible Side Effects of a HYAJOINT Plus Injection

HYAJOINT Plus injections when done by a trained practitioner are generally very safe, however like all medications there are some potential side effects which must be considered before deciding to go ahead with an injection.

Some people may experience initial irritations such as tenderness, redness and swelling after injection, this may last for several days, depending on the individual and the severity of osteoarthritis. The patient also may feel sensations of tingling or numbness. If such side effects do not go away after a reasonable amount of time, contact the orthopedic physician’s office to determine if an evaluation is warranted.

The injection is often given with some local anesthetic, once the anesthetic has worn off there may be some post injection pain, which usually lasts no more than 48 hours.

HYAJOINT Plus, A LONG TERM TREATMENT FOR SYMPTOMATIC OSTEOARTHRITIS WITH A SINGLE INJECTION FOR PAIN RELIEF AND RESTORING MOBILITY¹.

In a prospective study¹, HYAJOINT PlusTM relieved pain in patients with symptomatic knee OA for up to 6 months following a single course treatment¹. HYAJOINT Plus is both safe and effective for the treatment of knee OA.

The quadriceps thickness and FIC (femoral intercondylar cartilage) thickness under US (ultrasonography) were significantly improved at 6 months after HYAJOINT PlusTM injection compared to the baseline (p<0.001).

Safety data: No infections, allergies or other serious adverse events were reported.

 

Effectiveness of HYAJOINT Plus in a prospective, randomized, controlled, double-blind trial of Safety and Efficacy².

HYAJOINT Plus is superior to S brand in terms of reducing the VAS(Visual Analogue Scale) pain score at 1, 3, and 6 months and the WOMAC stiffness score at 6 months.
Better improvement of pain relief by 33.3 mm on VAS score in patients treated with HYAJOINT Plus compared to 23.4 mm in the S brand group at 6 months (mean difference between groups -6.6; p=0.045)².

The frequencies and types of adverse events were comparable between S brand and HYAJOINT Plus groups. The majority of adverse events were mild or moderate, lasted 1 to 3 days, and resolved 
spontaneously or responded well to simple analgesics. No allergies, pseudosepsis or serious adverse events occurred during the study in either group².

References
1. Tuan S., Liou I., Su H., Tsai Y., Chen G. and Sun S. Improvement of self-reported functional scores and thickening of quadriceps and femoral intercondylar cartilage under ultrasonography after single intra-articular injection of a novel cross-linked hyaluronic acid in the treatment of the knee osteoarthritis. JBMR. 2018 ; 31 : 709-718
2. Sun, S.F., Hsu, C.W., Lin, H.S., Liou I.H., Chen, Y.H. and Hung C.L. Comparison of Single Intra-Articular Injection of Novel Hyaluronan (HYA-JOINT Plus) with Synvisc-One for Knee Osteoarthritis. JBJS. 2017 ; 99(6) : 462-471