The Use of DXA in Scoliosis

NCT06512038 | Active Not Recruiting

• 1 other identifier: 335664
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis Idiopathic

Keywords

scoliosis; Juvenile Scoliosis; Adolescent Scoliosis

Outcome Measures

Primary Outcomes (5)

• Radiation Dosage

  DXA in comparison to X-Ray

  Through study completion, an average of 6 months

• Patient Satisfaction Questionnaire about the use of DXA in Scoliosis

  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

  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

  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

  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

Study Arms (1)

ADDITIONAL DEXA SCAN

OTHER

There is only 1 arm on this trial, if a participant agrees to take part they will have additional DEXA radiograph.

Radiation: DEXA Scan

Interventions

DEXA Scan RADIATION

If the participant consents to take part in the trial, they will have an additional DEXA scan.

ADDITIONAL DEXA SCAN

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sheffield Children's NHS Foundation Trust: lead
• University of Sheffield: collaborator

Study Sites (1)

Sheffield Children's NHS Foundation Trust

Sheffield, S10 2TH, United Kingdom

Location

MeSH Terms

Conditions

Scoliosis

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: July 22, 2024
• Study Start: May 8, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)