A Pilot Study of the Use of Dual-Energy X-ray Absorptiometry (DXA) in Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Patient Satisfaction Questionnaire about the use of DXA in Scoliosis
研究概览
简要总结
This is a pilot study to look at image quality of iDXA AP supine spinal images to see if the investigators can accurately measure the size of the curve from iDXA images and to see how patients with scoliosis feel about iDXA imaging compared to normal x-rays. With normal x-rays being taken standing (or sitting if patients are in a wheelchair), it is important that the investigators understand how the lying down images compare to the standing images. Where there may be some clinical benefit, images will be taken standing (normal x-rays) and lying down (iDXA images). The investigators will see if the addition of iDXA images can help in brace design and brace monitoring.
详细描述
This pilot study is an interventional study where patients having routine standing or sitting spinal x-rays for scoliosis monitoring or as part of a treatment protocol will be approached to see if they would have an additional supine AP DXA image. Participants will only have one additional DXA image during the pilot study. The consent will be obtained by one of the spinal surgeons or a specialist spinal nurse. The DXA scan will be performed by one of the radiographers. This study may be performed by a medical student or junior doctor (either would be part of the care team) and supervised by the PI.
The pilot study is expected to last 9 months and consist of 25 patients. The DXA images will be reviewed by 2 consultant spinal surgeons and a consultant radiologist who will make a collective decision every month as to whether the study, or that part of the study, should continue.
Two scoliosis patients have read the study protocol and given their input. The Sheffield Children's Hospital Scoliosis PPI group will feedback on key aspects during the study and help define future studies suggested by this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Adolescent Idiopathic Scoliosis (AIS, aged 10-16 years) or Juvenile Idiopathic Scoliosis (JIS, aged 4-9 years) having an x-ray to look for curve progression OR to guide design of a new brace.
- •Patients with quadriplegic Cerebral Palsy (CP) having an x-ray to look for curve progression. Within the age range for inclusion for patients with CP, the recruiting clinician will make a clinical judgement on whether the patient is able to lie still long enough to undertake the iDXA, before inviting the patient to take part.
排除标准
- •Parents unable to understand the study procedures.
- •Patients unable to lie still for 1-2 minutes
研究组 & 干预措施
ADDITIONAL DEXA SCAN
There is only 1 arm on this trial, if a participant agrees to take part they will have additional DEXA radiograph.
干预措施: DEXA Scan (Radiation)
结局指标
主要结局
Patient Satisfaction Questionnaire about the use of DXA in Scoliosis
时间窗: through study completion, an average of 6 months
This will be self reported questionnaire completed by patients. They will use a simple pictorial scale to report about their experiences having both a DXA and X-ray. The Scale ranges from 'Very Uncomfortable/ very unacceptable', 'Uncomfortable / unacceptable' to 'Okay'.
Imaging Angles
时间窗: Through study completion, an average of 6 months
Cobb angle, apical vertebral translation and apical vertebral rotation will be measured from the x-rays and DXA scans for all the curves
Radiation Dosage
时间窗: Through study completion, an average of 6 months
DXA in comparison to X-Ray
DXA Image Quality
时间窗: Through study completion, an average of 6 months
Image quality as judged by 2 spinal surgeons and a consultant radiologist on a 4 point scale as: 1. Excellent - almost as good as an x-ray 2. Good - Good quality and easily able to see required anatomical landmarks for measurement 3. Adequate - Poor quality but just able to see required anatomical landmarks for measurement 4. Poor - Unable to see required anatomical landmarks for measurement
Beighton Score for joint flexibility
时间窗: Through study completion, an average of 6 months
Beighton score (flexibility) will be recorded by a clinician for all the patients with idiopathic scoliosis. The score will evaluate each patient's: * Passive dorsiflexion and hyperextension of the fifth MCP joint beyond 90° * Passive apposition of the thumb to the flexor aspect of the forearm * Passive hyperextension of the elbow beyond 10° * Passive hyperextension of the knee beyond 10° * Active forward flexion of the trunk with the knees fully extended so that the palms of the hands rest flat on the floor
次要结局
未报告次要终点