Randomized Trail to Assess the Effectiveness of an Off-Loading Knee Brace When Combined With Viscosupplementation in the Treatment of Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Reduction in knee pain
研究概览
简要总结
Hypothesis: Viscosupplementation when combined with an off-loading knee brace is more effective in treating the symptoms of knee OA then treating with viscosupplementation alone
详细描述
A randomized prospective study to assess the effectiveness of treating knee osteoarthritis with either a series of three viscosupplementation injections, an off-loading knee brace, or a combination of viscosupplementation and an off-loading knee brace. The viscosupplementation and off-loading knee brace are being used in accordance with their FDA approval. Subjects will be randomized to 1 of 3 treatment groups. The control group will receive a series of weekly (3 consecutive weeks) intra-articular hyaluronic acid injections. The second group will receive a series of weekly (3 consecutive weeks) intra-articular hyaluronic acid injections and an off loading knee brace. The third group will use the off loading knee brace alone. Subjects will complete the WOMAC Osteoarthritis Questionnaire (pain, stiffness, function) and VAS pain scale (measuring pain on movement) at baseline, day 7, day 14, 6 weeks and 3 months. Subjects in group 2 and 3 will be given a brace diary to record compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects, over the age of 18, with a diagnosis of knee osteoarthritis which is confirmed by radiographs.
- •Radiographs will be obtained and patients with mild to moderate knee osteoarthritis will qualify a subject for enrollment.
- •Subjects will also have a documented varus deformity.
排除标准
- •Subjects with severe arthritis as demonstrated by radiographs.
- •In addition those subjects with a known or suspected joint infection and subjects who had undergone arthrocentesis and/or intra-articular injection within 3 months of the study will be excluded.
- •Female patients who are pregnant or breast feeding will also be excluded.
研究组 & 干预措施
Viscosupplementation injections
Control group will receive a series of three viscosupplementation injections into the affected knee
干预措施: Orthovisc (Other)
Off-loading knee brace
干预措施: DonJoy HA lite knee brace (Device)
Viscosupplementation and knee brace
干预措施: Orthovisc injections and DonJoy HA lite knee brace (Device)
结局指标
主要结局
Reduction in knee pain
时间窗: 3 months
The primary outcome measure will be a reduction in knee pain as measured by the VAS pain score. The secondary outcome measure will be an increase in function as measured by the WOMAC Osteoarthritis Questionnaire.
次要结局
未报告次要终点