The Use of DXA in Scoliosis

Phase

N/A

Condition

N/A

Treatment

DEXA Scan

Clinical Study ID

NCT06512038

335664

Ages 4-16
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients with Adolescent Idiopathic Scoliosis (AIS, aged 10-16 years) or JuvenileIdiopathic Scoliosis (JIS, aged 4-9 years) having an x-ray to look for curveprogression OR to guide design of a new brace.
Patients with quadriplegic Cerebral Palsy (CP) having an x-ray to look for curveprogression. Within the age range for inclusion for patients with CP, the recruitingclinician will make a clinical judgement on whether the patient is able to lie stilllong enough to undertake the iDXA, before inviting the patient to take part.

Exclusion

Exclusion Criteria:

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

Study Design

DEXA Scan

May 08, 2024

May 31, 2025

Study 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.

Connect with a study center

Sheffield Children's NHS Foundation Trust
Sheffield, S10 2TH
United Kingdom
Active - Recruiting

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