The Use of DXA in Scoliosis

April 15, 2026 updated by: Sheffield Children's NHS Foundation Trust

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Sheffield, United Kingdom, S10 2TH
        • Sheffield Children's NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ADDITIONAL DEXA SCAN
There is only 1 arm on this trial, if a participant agrees to take part they will have additional DEXA radiograph.
Radiation: DEXA Scan
If the participant consents to take part in the trial, they will have an additional DEXA scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation Dosage
Time Frame: Through study completion, an average of 6 months
DXA in comparison to X-Ray
Through study completion, an average of 6 months
Patient Satisfaction Questionnaire about the use of DXA in Scoliosis
Time Frame: 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'.
through study completion, an average of 6 months
DXA Image Quality
Time Frame: 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
Through study completion, an average of 6 months
Imaging Angles
Time Frame: 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
Through study completion, an average of 6 months
Beighton Score for joint flexibility
Time Frame: 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
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Children's NHS Foundation Trust

Collaborators

University of Sheffield

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2024

Primary Completion (Actual)

June 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

May 8, 2024

First Submitted That Met QC Criteria

July 15, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 335664

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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