Simple Bone Cysts in Kids (SBoCK)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 47
- 主要终点
- Cyst healing
研究概览
简要总结
Simple bone cysts (SBCs) are cysts filled with fluid that occur most frequently in the long bones (arms or legs) of children. There are many ways to treat SBCs but it is unclear if one is better than another. The purpose of this research trial is to compare the effectiveness of two common treatments that are used by surgeons today.
详细描述
In general, few randomized clinical trials have been undertaken in paediatric orthopaedics, and only one to date has addressed the problem of simple bone cysts (SBCs). Also known as unicameral bone cysts, they are the commonest bone lesion in children. Despite general opinion, these cysts do not resolve at skeletal maturity.
Many forms of treatment have been recommended but none, including the popular methods of corticosteroid or bone marrow injections, have reliably eradicated SBC. Although the lesions are considered benign (non-cancerous), they cause pain, frequently interfere with function, dramatically restrict play activity, may re-fracture leading to growth arrest and/or deformity, and cause enormous anxiety for children and their families.
With a well-developed network of surgeons and researchers, we will provide evidence comparing the effectiveness of two treatment interventions for SBC. More specifically, our goals for this study are:
- to compare the rate of radiographic healing between two standard treatments including curettage with puncture alone, and curettage with puncture followed by injection with Vitoss morsels;
- to identify prognostic radiographic factors associated with simple bone cyst healing and fracture;
- to determine the impact of simple bone cyst on children/family functioning.
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
- Double (Participant, Outcomes Assessor)
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
- 否
入选标准
- •Patients with a confirmed simple bone cyst in a long bone (ie. arm or leg) within last 3 months
- •At least 3 weeks must have elapsed since last fracture
- •At least 3 months must have elapsed since last cyst treatment
- •Patients and/or their legal representatives willing to provide written informed consent (and assent, when appropriate)
- •Patients with stabilizing implants in the bone where the cyst is located
排除标准
- •Patients with bone disease (ie. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)
- •Pregnant or breastfeeding female
- •Patients with cysts crossing the growth plate (area where bone grows)
结局指标
主要结局
Cyst healing
时间窗: 2 years
Healing will be graded according to a 4-point modified Neer's classification by radiologists
次要结局
- Functional measures (Questionnaire scores)(1 and 2 years)
- Clinical measures (Cyst features)(1 and 2 years)
研究者
James Wright
Orthopaedic Surgeon
The Hospital for Sick Children