NCT06512038

The Use of DXA in Scoliosis

A Pilot Study of the Use of Dual-Energy X-ray Absorptiometry (DXA) in Scoliosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sheffield Children's NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 4 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Scoliosis Idiopathic

Interventions

Type	Name	Description
RADIATION	DEXA Scan	If the participant consents to take part in the trial, they will have an additional DEXA scan.

Timeline

• Start date: 2024-05-08
• Primary completion: 2024-12-06
• Completion: 2025-05-31
• First posted: 2024-07-22
• Last updated: 2024-07-22

Locations

1 site across 1 country: United Kingdom