NCT00323778终止3 期
Prospective Assessment of the Efficacy of Intra-Articular Hyaluronate to Affect Extracellular Matrix Changes in Patients With Osteoarthritis
Hospital for Special Surgery, New York1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2006年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
This study looks at the effect of an injectable medication called Hyalgan on the cartilage of the knee in people who have osteoarthritis ("wear and tear arthritis") of the knee. Hyalgan is a medication which is injected into the knee, and is FDA approved to treat knee arthritis. We will be using magnetic resonance imaging (MRI) and x-rays to look at knee cartilage to see how it responds over the course of a year to the injections. A comparison to patients taking oral pain medication will be made.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 45-90
- •seeking medical care for painful knee osteoarthritis
- •alignment based on AP standing radiographs of neutral to 10º of valgus
- •no prior surgery on the ipsilateral knee
- •no history of major trauma to either knee or either hip
- •no history of congenital hip dysplasia
- •No history of inflammatory synovitis or crystalline arthropathy
- •No history of systemic rheumatic disease
- •cruciate and collateral ligament stability, defined by clinical examination
- •meniscus intact (MRI grade II degenerative signal acceptable)
- •Noyes compartment score: no greater than 50% of cartilage thickness over an area greater than 15mm
- •If bilateral OA, the most painful knee, (as documented by VAS scale for pain) which qualifies for the study will be entered.
- •If taking glucosamine chondroitin sulfate, discontinue at least one month prior to HA injections
排除标准
- •previous IA HA injection in the ipsilateral knee
- •IA steroid in the ipsilateral knee in the past 3 months
- •MR evidence of inflammatory or hypertrophic synovitis
- •Large joint effusion with a ballotable patella on baseline clinical exam
- •Inability to safely perform MR imaging
- •Active systemic infection
- •Active malignancy (except non-melanomatous skin cancer)
- •Allergies to HA or chicken products
- •Clinical symptoms of an acute meniscal tear (locking, new acute mechanical symptoms etc…)
- •A recent injury to the knee
- •Radiographic evidence of Grade III or IV Kellgren and Lawrence OA
- •Chondrocalcinosis on radiographs
- •Unwilling to discontinue or avoid glucosamine chondroitin sulfate for the 12 month study period
- •People taking blood thinners or who have bleeding problems
- •Anticipated lower extremity surgery during the next 12 months
- •BMI >30 kg/m2
研究者
研究点 (1)
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