A Single-Blind Prospective Parallel Control Group Pilot Study to Assess the Effect of Hylan G-F 20 (Synvisc) Supplementation on Cartilage Preservation in Osteoarthritis of the Knee

Cabrini Medical Centre1 个研究点分布在 1 个国家目标入组 80 人开始时间: 2006年1月1日最近更新: 2006年10月27日

适应症

试验速览

阶段: 4 期
发起方
入组人数: 80
试验地点: 1
主要终点: Cartilage volume as assessed by magnetic resonance imaging

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

That Hylan G-F 20 may act to protect cartilage from the expected degree of degradation over a 12 month period in subjects with moderate to marked osteoarthritis of the knee

详细描述

Two courses of Hylan G-F 20 ( Synvisc) administered by intra-articular injection at 6 monthly intervals. MRI examinations of the knee for estimation of cartilage volume prior to treatment, before second course and at 12 months in 40 subjects with Grade 2/3 osteoarthritis of knee . A further 40 subjects with similar degree of osteoarthritis of knee who do not receive Hylan G-F therapy will be assessed by MRI in identical manner.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Single

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•grade 2 or 3 osteoarthritis knee age 18 - 80 pain score VAS >39 mm on 100mm scale

排除标准

•surgery in prior 12 months significant valgus deformity recent trauma use of opioid analgesia unstable medical condition recent corticosteroid injection morbid obesity

结局指标

主要结局

Cartilage volume as assessed by magnetic resonance imaging

次要结局

未报告次要终点

研究者

发起方

Cabrini Medical Centre

申办方类型

Other

研究点 (1)

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