Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Z-scores obtained using quantitative ultrasound
研究概览
简要总结
Simple bone cysts (SBCs), also known as unicameral bone cysts (UBCs), are benign bone lesions. Literature to date describes little agreement between clinicians on specific prognostic criteria for the prediction of cyst healing, recurrence or fracture. Evidence has shown that bone mineral density (BMD) is a reliable indicator of risk to SBC patients given its association with the mechanical properties of bone. There has been further exploration into the use of quantitative ultrasound to assess bone density by measuring the velocity of the ultrasound transmission over the bone. To determine whether the QUS can provide prognostic information with respect to cyst healing, recurrence or fracture with a SBC, further study is needed.
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
- 2 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Arm 1 - Simple Bone Cyst Patients
- •Inclusion Criteria
- •Patients ≥ 2 and ≤ 21 years
- •Patients with a diagnosis of simple bone cyst located in a long bone confirmed by imaging within 3 months prior to registration
- •All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
排除标准
- •Patients with implants to stabilize the bone where the cyst is located.
- •Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)
- •Patients who are pregnant or breastfeeding
- •Patients with a simple bone cyst crossing the growth plate
- •Arm 2 - Healthy Controls
- •Inclusion Criteria
- •Patients ≥ 2 and ≤ 21 years
- •All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
- •Exclusion Criteria
- •Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)
- •Patients receiving any bone-modifying agents (i.e. steroids, bisphosphanates, etc.)
- •Patients who are pregnant or breastfeeding
- •Arm 3 - Fracture patients
- •Inclusion Criteria
- •Patients ≥ 2 and ≤ 21 years
- •Patients who have undergone any type of casting or surgical treatment for their fracture
- •All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
- •Exclusion Criteria
- •Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)
- •Patients receiving any bone-modifying agents (i.e. steroids, bisphosphanates, etc.)
- •Patients who are pregnant or breastfeeding
研究组 & 干预措施
Simple Bone Cyst Patients
Z-score measurements will be taken from the mid-shaft tibia and distal third of the radius of both extremities where possible using quantitative ultrasound at baseline and once annually for 2 years.
There will also be optional blood samples taken o measure bone alkaline phosphatase.
干预措施: Sunlight Omnisense Quantitative Ultrasound (Device)
Fracture patients
Z-score measurements will be taken from the mid-shaft tibia and distal third of the radius of both extremities where possible using quantitative ultrasound at baseline, after 3 months and at future follow-up visits as clinically indicated or at a one year follow-up visit.
There will also be optional blood samples taken to measure bone alkaline phosphatase.
干预措施: Sunlight Omnisense Quantitative Ultrasound (Device)
Health volunteers
Z-score measurements will be taken from the mid-shaft tibia and distal third of the radius of both extremities where possible using quantitative ultrasound at baseline, after 3 months and at a one year follow-up visit.
There will also be optional blood samples taken to measure bone alkaline phosphatase.
干预措施: Sunlight Omnisense Quantitative Ultrasound (Device)
结局指标
主要结局
Z-scores obtained using quantitative ultrasound
时间窗: 2 years
次要结局
- Bone specific alkaline phosphatase(2 years)
研究者
James Wright
Orthopaedic Surgeon
The Hospital for Sick Children