None listed
Conditions
Interventions
Intervention1: Synvisc-One (hylan G-F 20): injection: 6ml
Control Intervention1: NIL: NIL
Sponsors
Genzyme India Pvt. Ltd.
Max Neeman International Max House
Eligibility
Inclusion criteria
Inclusion criteria: - Male and female patient aged 30 years or older, with active lifestyle. - The patient must be able to read, understand and sign an informed consent form, understand requirements for follow-up visits and must be willing to provide information at the scheduled evaluations. -The patient has a diagnosis of OA of the Target Knee confirmed by recent X-Ray (mild to moderate joint space narrowing and/or osteophytes (i.e. Kellgren Lawrence (KL) grade I-III), predominant in the tibio-femoral compartment. WOMAC A1 baseline 100mm VAS score between 40-80mm (moderate or severe walking pain) in the Target knee. - Patients with bilateral disease may be included in the study under certain conditions: i.) Only one knee (considered the "Target Knee") will be included in the efficacy assessment, and must meet all other inclusion/exclusion criteria ii.) The non-target knee may also be treated with Synvisc-One and does not need to meet the specific Kellgren Lawrence (KL) grade inclusion criteria described above. All other inclusion/exclusion criteria do apply. - If female, must have a negative 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
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, chondrocalcinosis etc.). - History of sepsis in any joint or any clinical concern for a sub-acute 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 Intra-Articular (IA) steroid in the previous 3 months. - Any contra-indication to IA injection eg, anticoagulant therapy or clinical concern for potential coagulopathy (e.g. liver disease). - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in WOMAC (Western Ontario and McMaster Universitites OA Index VAS) A1 subscore (walking pain)Timepoint: at baseline and 26 weeks;Treatment Emergent Adverse EventsTimepoint: During primary and repeat treatment phases | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in 12-Item Short Form Health Survey (SF-12)Timepoint: baseline and week 12, 26, and 52;Change in concomitant OA therapyTimepoint: over 26 weeks; and between baseline and week 1, 4, 12, 26, 39, and 52;Change in Patient Global Assessment (PTGA) and Clinical Observer Global Assessment (COGA) scoreTimepoint: baseline and week 1, 4, 12, 26, 39, and 52;Change in WOMAC A, B, and C scoreTimepoint: baseline and week 1, 4, 12, 26, 39, and 52;Change in WOMAC A1 subscore (walking pain)Timepoint: at baseline and week 1, 4, 12, 39, and 52;Change in WOMAC A1 subscore, A, B, and C scoreTimepoint: between repeat treatment visit and week 1 and 4 after repeat treatment;Time period between first Synvisc-One treatment and re-treatment in the Target KneeTimepoint: up to 52 weeks | — |
Countries
India
Contacts
Public ContactDr. Senthilnathan Mohanasundaram
Medical Director, Genzyme
Outcome results
None listed