Arthritis Clinical Trials

Inclusion criteria :

1. The subjects have a diagnosis of OA of the Target Knee confirmed by recent X-Ray (mild to moderate joint space narrowing and/or osteophytes predominant in the tibiofemoral compartment).
2. WOMAC A1 baseline 100mm Visual Analog Score (VAS) between 40-80mm (moderate or severe walking pain) in the Target knee.

3. Subjects with bilateral disease may be included in the study with the below strict conditions:

   • Only one knee will be included in the efficacy assessment and will be considered the Target Knee (The worst knee by the WOMAC A1 pain scale should be selected). The selected knee must meet the inclusion and exclusion criteria.
   • The non-target knee may also be treated with Synvisc® and does not need to meet the Kellgren-Lawrence (KL) grade knee specific inclusion criteria described above. The other criteria do apply, and will be included in safety assessment.
4. Pre-menopausal female subjects must have a negative urine pregnancy test and continue to use a medically acceptable form of contraception for the duration of the study. Otherwise, females must have been surgically sterile, or postmenopausal (as documented in medical history) for at least 1 year.

Exclusion criteria:

1. Significant (requiring surgical correction) valgus or varus deformity of the knee, ligamentous laxity, or meniscal instability.
2. Concomitant inflammatory or any other disease/condition which may affect joints (e.g., rheumatoid arthritis, metabolic bone disease, psoriasis, gout, pseudogout, chondrocalcinosis etc.).
3. History of sepsis in any joint or any clinical concern for a sub-acute infectious process in the target joint.
4. History of surgery in the target knee (if done < 6 months).
5. Planned surgery on any lower extremity joint.
6. Clinically significant venous or lymphatic stasis present in the leg(s).
7. Clinically apparent tense effusion or inflammation at the target knee.
8. Skin disease or infection in the area of the injection site.
9. Any musculoskeletal condition that would impede measurement of efficacy at the target knee.
10. Pregnant or lactating women.
11. Hypersensitivities to avian proteins and/or any components of hyaluronan-based injection.
12. Treatment with any Hyaluronic Acid (HA) or derivatives in the previous 6 months.
13. Treatment with Intra-Articular (IA) steroid in the previous 3 months.
14. Any contra-indication to IA injection e.g., anticoagulant therapy or clinical concern for potential coagulopathy (e.g. liver disease).
15. Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.