Study of Safety and Efficacy of 6 mL Synvisc-One (Hylan G-F 20) in Indian Patients With Symptomatic Osteoarthritis of Knee(s) After Initial and Repeat Treatment
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Synvisc-One
Intervention description: intraarticular injection
Intervention MeSH terms: Hylan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 394.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To evaluate the safety and efficacy of a single 6 mL intraarticular (IA) injection of
      Synvisc-One in participants in India with symptomatic osteoarthritis (OA) of the knee(s).

      Secondary Objective:

      To evaluate the safety and short-term efficacy of a repeat treatment with Synvisc-One.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participant aged 30 years or older, with active lifestyle.

          -  The participant must be able to read, understand, and sign an informed consent form,
             understand requirements for followup visits, and must be willing to provide
             information at the scheduled evaluations.

          -  The participant had a diagnosis of OA of the target knee confirmed by recent X-ray
             (mild to moderate joint space narrowing and/or osteophytes (ie, Kellgren Lawrence [KL]
             Grade I-III), predominant in the tibiofemoral compartment.

          -  WOMAC A1 baseline 100 mm visual analog scale (VAS) score from 40-80 mm (moderate or
             severe walking pain) in the target knee.

          -  Participants with bilateral disease may be 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 may also be treated with Synvisc-One and does not need to
                  meet the KL grade knee specific inclusion criteria described above. The other
                  criteria do apply.

          -  If female, must had a negative urine pregnancy test and continue to use a medically
             acceptable form of contraception for the duration of the study. Otherwise, females
             must had been surgically sterile or postmenopausal (as documented in the medical
             history) for at least 1 year.

        Exclusion Criteria:

          -  Significant (requiring surgical correction) valgus or varus deformity of the knee,
             ligamentous laxity, or meniscal instability.

          -  Concomitant inflammatory or any other disease/condition which may affect joints (eg,
             rheumatoid arthritis, metabolic bone disease, psoriasis, gout, pseudogout, or
             chondrocalcinosis).

          -  History of sepsis in any joint or any clinical concern for a subacute infectious
             process in the target joint.

          -  History of surgery in the target knee.

          -  Planned surgery on any lower extremity joint.

          -  Clinically significant venous or lymphatic stasis present in the leg(s).

          -  Clinically apparent tense effusion or inflammation at the target knee.

          -  Skin disease or infection in the area of the injection site.

          -  Any musculoskeletal condition that would impede measurement of efficacy at the target
             knee.

          -  Pregnant or lactating women.

          -  Hypersensitivities to avian proteins and/or any components of hyaluronan-based
             injection.

          -  Treatment with any hyaluronic acid (HA) or derivatives in the previous 6 months.

          -  Treatment with IA steroids in the previous 3 months.

          -  Any contraindication to IA injection, eg, anticoagulant therapy or clinical concern
             for potential coagulopathy (eg, liver disease).

          -  Any significant medical condition (eg, significant psychiatric or neurological
             disorders or active alcohol/drug abuse), any medical condition that is unstable/poorly
             controlled or other factors (eg, 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.