Clinical Study of Artz in the Treatment of Knee Osteoarthritis (Artz)

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Sodium Hyaluronate, mild to moderate knee osteoarthritis Read More

Inclusion Criteria:

1. Adult Chinese subjects, at age≥18, either gender, diagnosed with osteoarthritis of the target knee and Kellgren-Lawrence (KL) classification Grade 1~3, as evidenced by X-ray examination in the last 3 months (mild to moderate narrowing of joint space and / or marked osteophytes of tibiofemoral joint space)
2. Persist pain of the target knee after exercise, weight loss and physical therapy;
3. A baseline WOMAC A1 score for the target knee rated at 40-90mm (moderate to severe walk-associated pain) on 100mm Visual analogue scale(VAS); Able to understand and sign the Informed Consent Form (ICF) that has already been approved by the Independent Ethics Committee (IEC) Note: the informed consent may also be given by the duly authorized representative of the subject.

Exclusion Criteria:

1. A diagnosis of bilateral knee osteoarthritis;
2. Clinically significant (requiring surgery) valgus or varus deformity of the knee joint, ligamentous laxity or unstable meniscus;
3. Complicated by inflammation or any other disease /condition (e.g., rheumatic arthritis, metabolic bone disease, psoriasis, gout, pseudogout, chondrocalcinosis, etc.) that may affect the knee joint;
4. A history of septicemia, clinically considered sub-acute infection of the target knee joint;
5. A history of surgery on the target knee (in the last 6 months);
6. A history of asthma, urticaria or allergy after use of aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs);
7. Severe hepatic or renal disease or hepatic /renal failure;
8. Any unscheduled surgery on the lower limb;
9. Clinically significant lower venous or lymphatic obstruction;
10. Clinically significant obvious exudation or inflammation of the target knee;
11. Skin disorders or infection at the injection site;
12. Pregnant or lactating women;
13. Known allergy to guanylin and / or any active ingredient or excipient of hyaluronic acid-based injection / diclofenac sodium;
14. Treatment with any hyaluronic acid (HA) or its derivatives for the target knee within six months before this trial;
15. Intra-articular (IA) injection of steroids into the target knee within 3 months before this trial;
16. Presence of any contraindication to IA injection, e.g., patients who are receiving anti-coagulation therapy or clinically have potential coagulation disorders (e.g., hepatic disease);
17. Presence of any clinically significant disease (e.g., significant mental or nervous disorders, alcohol/drug abuse), unstable/poorly controlled diseases, or other factors, which may affect their evaluation or participation in this study in the investigator's judgment
18. Perioperative pain associated with coronary artery bypass surgery (CABG);
19. A history of gastrointestinal bleeding or perforation following use of NSAIDs;
20. Presence of active gastrointestinal ulcer /bleeding, or a past history of recurrent ulcer/bleeding; Chief complaint complicated by pain beyond the target knee,