A Study of the Efficacy and Safety of Synvisc® in Chinese Subjects With Symptomatic Osteoarthritis of the Knee(s)
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Hylan G-F 20
Intervention description: Intra-articular injection (pre-filled glass syringe)
Intervention MeSH terms: Hylan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 237.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No

Summary:

      Primary Objective:

        -  To evaluate the change of Western Ontario and McMaster Universities Osteoarthritis Index
           (WOMAC) A1 subscore (walking pain) at 26 weeks compared to the Baseline score

        -  To evaluate the safety using the incidence, severity, seriousness, relatedness, and
           frequency of all treatment emergent Adverse Events (AEs)

      Secondary Objectives:

        -  To evaluate the change in WOMAC A1 subscore (walking pain) between baseline and weeks 8,
           and 12

        -  To evaluate the change in WOMAC A, B and C score between baseline and weeks 8, 12 and 26

        -  To evaluate the change in Patient Global Assessment (PTGA) score between baseline and
           weeks 8, 12 and 26

        -  To evaluate the change in Clinical Observer Global Assessment (COGA) score between
           baseline and weeks 8, 12 and 26

        -  To evaluate the change in concomitant Osteoarthritis (OA) therapy over 26 weeks and
           between baseline and weeks 1, 2, 8, 12 and 26
    

Eligibility criteria:

        Inclusion criteria :

          1. The participants had 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 100 mm Visual Analog Score (VAS) between 40-80 mm (moderate or
             severe walking pain) in the Target knee

          3. Participants with bilateral disease included in the study with the below strict
             conditions:

               -  Only one knee included in the efficacy assessment and 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 might also be treated with Synvisc® and did not need to meet
                  the Kellgren-Lawrence (KL) grade knee specific inclusion criteria described
                  above. The other criteria applied, and included in safety assessment

          4. Pre-menopausal female participants had a negative urine pregnancy test and continue to
             use a medically acceptable form of contraception for the duration of the study.
             Otherwise, females had 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 might 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. Presence of clinically significant venous or lymphatic stasis 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 was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.