The Use of Bone Growth Stimulators for Osteoarthritis of the Knee.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Intraosseous Venous Congestion measured by Intraossous Pressure.
研究概览
简要总结
The hypothesis of this study is that since osteoarthritis of the knee is primarily a bone disease where the joint changes are secondary, and bone growth stimulators function to decrease intraosseous venous congestion and remodel bone, then there is a potential benefit for the treatment of osteoarthritis of the knee with bone growth stimulators.
详细描述
The hypothesis of this study is based on the knowledge that osteoarthritis of the knee is primarily a bone disease, and the joint changes are secondary. Bone growth stimulators function to alleviate intraosseous venous congestion through the process of bone remodeling. The working hypothesis is that alleviation of intraosseous venous congestion leads to improved delivery of nutrition to the tissue to support the health of the bone with improvement in biomechanics leading to clinical improvement. Venous congestion is measured with intraosseous pressure. Additional objective evidence of biomarkers of bone metabolism as well as measurements of subjective questionnaires can provide evidence of benefit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must have diagnosis of osteoarthritis of the knee with radiographic evidence of joint space narrowing, Kellgren-Lawrence Classification grade Grade 3 or
- •Subjects must discontinue corticosteroids administered by any route except intranasal spray, steroid- containing ophthalmic solutions and anti-asthmatics.
- •Subjects must speak English.
- •Subject must be willing and able to sign an informed consent document.
- •Subjects must be willing and able to comply with all study procedures for the duration of the clinical study.
排除标准
- •Subjects with a diagnosis of inflammatory arthritis such as rheumatoid arthritis, gout, joint infection, Lyme disease, or systemic lupus erythematosus.
- •Subjects with a diagnosis of secondary arthritis such as acromegaly, Charcot's arthropathy, hemochromatosis, or Wilson's disease.
- •Subjects who have had an injury to the index knee within 6 months of starting treatment.
- •Subjects must NOT have had arthroscopy within 8 weeks of starting treatment.
- •Subjects must NOT have had viscosupplementation within 8 weeks of starting treatment.
- •Subjects who plan to have surgery on the target knee within the study period.
- •Subjects with surgical metallic hardware in the target knee.
- •Subjects who are unwilling or unable to adhere to the follow up schedule and procedures.
- •Subjects who are pregnant.
研究组 & 干预措施
Experimental Group
Participants use active Ultrasound Bone Growth Stimulator device according to Investigational Protocol.
干预措施: Ultrasound Bone Growth Stimulator (Device)
结局指标
主要结局
Intraosseous Venous Congestion measured by Intraossous Pressure.
时间窗: 14 weeks
Statistically significant decrease in intraosseous pressure following treatment.
次要结局
- C- telopeptide.(14 weeks)
- Change over time in WOMAC score.(14 weeks)
- Human Matrix Metalloproteinase-3 (MMP-3)(14 weeks)