Clinical trial NCT06512038: The Use of DXA in Scoliosis
Official title: A Pilot Study of the Use of Dual-Energy X-ray Absorptiometry (DXA) in Scoliosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Scoliosis Idiopathic
Keywords: scoliosis
Juvenile Scoliosis
Adolescent Scoliosis
Lead sponsor: Sheffield Children's NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Sheffield
First posted: 2024-07-22
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Parents unable to understand the study procedures.
* Patients unable to lie still for 1-2 minutes

Primary outcomes:
measure: Radiation Dosage
timeFrame: Through study completion, an average of 6 months
measure: Patient Satisfaction Questionnaire about the use of DXA in Scoliosis
timeFrame: through study completion, an average of 6 months
measure: DXA Image Quality
timeFrame: Through study completion, an average of 6 months
measure: Imaging Angles
timeFrame: Through study completion, an average of 6 months
measure: Beighton Score for joint flexibility
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Children's NHS Foundation Trust
Study officials:
References: