New Tools for Assessing Fracture Risk
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Osteoprobe Measurements
研究概览
简要总结
The goal of this study is to determine whether two new, non-X-ray techniques can discriminate between high-energy fractures of normal bone (trauma) and low-energy fractures (fragility) of osteoporotic bone. The current gold-standard for assessing fracture risk areal bone mineral density (aBMD) by dual energy X-ray absorptiometry (DXA) is not particularly effective at identifying individuals who are at risk of suffering a fracture. Yet, there is a growing population of diabetics and elderly individuals prone to fractures. In effect, the age-related and diabetes-related increase in fracture risk is independent of a person's aBMD. These findings stress the urgency in developing diagnostic tools that can improve fracture risk prediction so that patients can be treated with the appropriate anti-fracture therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Osteoprobe Measurements
时间窗: Within a week before or after surgery to repair distal radius fracture
Bone Material Strength index (BMSi) By engaging the bone at 10 N and then delivering a single impact force of \~40 N, the OsteoProbe records the maximum penetration depth of conical-spherical tip into cortical bone. This indentation distance increase (IDI) is indexed to the IDI acquired from a reference material immediately after the bone IDI measurements, such that the OsteoProbe-based measurement known as bone material strength index (BMSi) is 100 times IDI of reference material divided by IDI of the patient's bone. A lower BMSi measurement is the result of a higher indentation distance into the bone. For statistical analysis, we used the mean of the 10 BMSi measurements per case.
MRI Scan Measurements
时间窗: Within a week before or after surgery to repair distal radius fracture
Bound Water Fraction
DXA Scan Measurements
时间窗: Within a week before or after surgery to repair distal radius fracture
Bone Mineral Density
次要结局
- Patient-reported Measurements(Baseline and Post-op/-treatment: 3, 6, and 12 weeks)
研究者
Jeffry Nyman
Assistant Professor of Orthopaedics and Rehabilitation
Vanderbilt University Medical Center