Functional and Quality of Life Outcomes Following Hyaluronic Acid (HA) Viscosupplementation for Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
This study will compare changes in outcomes following viscosupplementation for knee osteoarthritis.
详细描述
The specific aims of this study are to compare the changes in knee pain symptoms, physical function, gait parameters and quality of life in persons with knee OA following a standard viscosupplementation injection series of hyaluronic acid (HA) over a one year period.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 years of age or older
- •osteoarthritis degeneration, degenerative joint disease or degeneration
- •fully cognizant of study procedures
- •willing to carefully participate in all study processes and assessments
排除标准
- •less that 21 years of age
- •allergic reactivity to hyaluronic acid
- •current knee infection, infection around injection site or any skin disease
- •pregnancy or lactation
- •non-ambulatory
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: Decsribes any change from baseline over a period of 12 months; the study subjects will complete the (WOMAC) Index at baseline, 1, 3, 6 and 12 months following the viscosupplementation of the knee.
The (WOMAC) Index is a multidimensional, self-administered health status instrument for patients with osteoarthritis of the hip or knee. The index is a disease-specific, purpose built, high performance instrument for evaluative research in osteoarthritis clinical trials.
次要结局
- Six Minute Walk Test; describes any change from baseline in leg pain following viscosupplementation of the knee.(The study subjects will complete the six minute walk test at baseline, 1, 3, 6 and 12 mos. following viscosupplementation of the knee.)
- Medical Outcomes Short Form (SF-36); completed to describe any change in perceived Quality of Life (QOL) from baseline following viscosupplementation of the knee.(The study subjects will complete the (SF-36) at baseline, 1, 3, 6 and 12 mos. following viscosupplementation of the knee.)
- Chair Rise Time; describes any change from baseline in time to rise from a chair following viscosupplementation of the knee(The study subjects will complete the chair rise at baseline, 1, 3,6 and 12 mos. following viscosupplementation of the knee.)
- Stair Climb Time; describes any change in the time from baseline to walk up a flight of 12 steps following viscosupplementation of the knee(The study subjects will complete the stair climb at baseline, 1, 3, 6 and 12 mos. following viscosupplementation of the knee.)
- Visual Analog Scale (VAS) documentation of the level of knee pain. The (VAS) will describe the change in the level of knee pain from baseline following viscosupplementation of the knee.(The study subjects will complete the (VAS) at baseline, 1, 3, 6 and 12 months following the viscosupplementation of the knee.)
- Gait Analysis; describes any changes in gait from baseline following viscosupplementation of the knee.(The study subjects will complete the gait analysis at baseline, 1, 3, 6 and 12 mos. following viscosupplementation of the knee.)