CTRI/2010/091/000052已完成4 期
Multicenter, Prospective, Open Label Study of the Safety and Efficacy of 6ml Synvisc-One (Hylan G-F 20) in Indian Patients With Symptomatic Osteoarthritis of the Knee(s) After Initial and Repeat Treatment
Genzyme India Pvt. Ltd.0 个研究点目标入组 400 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •- 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.
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