Clinical Evaluation of New Bone Formation During Limb Lengthening in Children by Ultrasound Combined With Superb Microvascular Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Gray scale of US in bone gap.
研究概览
简要总结
In the present study, The use of ultrasound allows observation of new bone formation in the distraction gap, also visualize the formation of blood vessels in the distraction gap, including the velocity and resistance of blood vessels, and can also indicate the environment of new bone formation. It's considered that ultrasound detection of new bone and angiogenesis in the process of bone lengthening in children could be a good supplement to X-ray evaluation, and even partially replace the former, reducing the radiation burden of pediatric patients.
详细描述
Limb lengthening is one of most common surgical techniques for correcting limb deformities in pediatric patients. The evaluation of new bone formation in the distraction gap is very important for the prognosis of limb lengthening. After limb lengthening, weekly or biweekly plain X-ray is the most commonly-used method to evaluate new bone formation in the distraction gap. However, Ordinary X-ray (film or digital) cannot provide details of regeneration or vascular regeneration like ultrasound examination, and radiation damage caused by X-ray or CT has unpredictable negative effects on minors. Ultrasound and X-ray examination were performed every 2 weeks during lengthening in 30 pediatric patients. Ultrasound was used to observe the formation of new bone, the number of vertical vessels and the blood flow resistance index, which were compared with the corresponding X-ray findings.New bone states could be divided by US into three stages: stage I (early lengthening): no obvious callus formation was found X-ray and ultrasound; stage II (lengthening stage): X-ray showed low density callus formation and uneven density, which was divided into three stages by ultrasound: IIa, punctate callus could be seen; IIb, linear callus was found, but not connected; IIc, connected linear callus was found; stage III (healing stage): the broken ends of the bone were joined, the periosteum was continuous, and the callus had disappeared. X-ray showed healing of the lengthened bone.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All are children who suffer limb length discrepancy and need limb-lengthening procedure; with no difference in sex, age or ethics.
排除标准
- •Space of braces is smaller than the probes.
结局指标
主要结局
Gray scale of US in bone gap.
时间窗: From the first day of lengthening to the removal of the external fixator.（Approximately 6 months.）
New bone states were divided into three stages: stage I (early lengthening): no obvious callus formation was found X-ray and ultrasound; stage II (lengthening stage): X-ray showed low density callus formation and uneven density, which was divided into three stages by ultrasound: IIa, punctate callus could be seen; IIb, linear callus was found, but not connected; IIc, connected linear callus was found; stage III (healing stage): the broken ends of the bone were joined, the periosteum was continuous, and the callus had disappeared.
New vessels of bone gap.
时间窗: From the first day of lengthening to the removal of the external fixator.（Approximately 6 months.）
The number of vessels in the lengthening gap, assessed via ultrasound techniques like SMI, reflects the vertical vessels growing into the distraction gap. This metric offers insights into the microvascular environment and angiogenesis of the new bone, aiding in evaluating healing progress and guiding lengthening protocol adjustments.
Resistance index of new vessles.
时间窗: From the first day of lengthening to the removal of the external fixator.（Approximately 6 months.）
The resistance index of new vessels, measured using ultrasound techniques like SMI, assesses blood flow resistance in the newly formed vessels within the lengthening gap.
Healing index
时间窗: From the first day of lengthening to 2 months after the removal of the external fixator.（Approximately 8 months.）
The healing index, calculated as healing time in months divided by lengthening distance in centimeters, serves as an objective indicator of limb lengthening prognosis. A smaller healing index signifies a faster healing rate.
次要结局
未报告次要终点