Prospective Randomized Controlled Trial of the Efficacy of Low-Magnitude, High-Frequency Vibration Treatment on Osteoporotic Hip Fracture Healing
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Fracture healing rate
研究概览
简要总结
Osteoporotic hip fracture is common in elderly. As a result of aging population in Hong Kong, the total number of hip fracture cases is anticipated to increase substantially in the future, and therefore draw more resources in hospitals and healthcare cost. Osteoporotic hip fracture usually causes severe pain and takes long time (4-8months) to recover due to impaired healing capability in osteoporotic bones and limited mobility. Consequently, the patients will recover very slowly as a result of low physical activities to provide inadequate mechanical stimulation. It is also known that mechanical, vascular and biological factors are the keys for fracture healing.
Low-magnitude, high-frequency vibration (LMHFV) treatment is a biophysical intervention to provide whole-body vibration signals for mechanical stimulation, which has been proven to be good in enhancing bone and muscle performance, as well as blood circulation. Our previous study of LMHFV on femoral fracture in rats showed acceleration of fracture healing, resulted from enhanced callus formation and maturation. Application of LMHFV on osteoporotic fractures could shorten the period of complete callus bridging by 30%. Our clinical trial on normal elderly also demonstrated improved muscle performance with good compliance, which is also a critical factor for fracture healing.
In this study, the investigators therefore hypothesize that LMHFV can enhance hip fracture healing by enhancing fracture impaction, maintaining bone mineral density, enhancing muscle recovery, thus improving implant mechanical stability and rehabilitation in elderly patients. The hip fracture elderly patient will be recruited and randomized into control or treatment group. They will be assessed on the fracture healing at fixed time point. The findings of this study will provide very useful scientific data to support the application of LMHFV for hip fracture patients.The ultimate goal is to enhance the fracture healing and rehabilitation in elderly patients.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •unilateral hip fracture patients older than 65 years old
- •patient fixed with dynamic hip screw
排除标准
- •unstable vital signs, large amount of drainage, or wound infection postoperatively
- •having of hormone replacement therapy or drug treatment known to affect bone metabolism or cause spontaneous bone loss
- •having hypo- or hyperparathyroidism and hypo-, hyperthyroidism, renal or liver disease
- •cannot tolerate or complication occurs during study
- •patients whose fracture is due to underlying disease, secondary to malignancy
结局指标
主要结局
Fracture healing rate
时间窗: up to 6 months
次要结局
- Balancing ability(second month and sixth month post treatment)
研究者
Kwok-Sui Leung
Professor
Chinese University of Hong Kong