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Active, Not Recruiting

NCT Number: NCT06512038

The Use of 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Scoliosis Idiopathic Bone Diseases Musculoskeletal Diseases Scoliosis Spinal Curvatures Spinal Diseases

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheffield Children's NHS Foundation Trust

Sheffield, S10 2TH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DEXA Scan

Radiation

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

Primary outcomes

  1. Radiation Dosage

    Time frame: Through study completion, an average of 6 months

    DXA in comparison to X-Ray

  2. 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'.

  3. 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:

    • Excellent - almost as good as an x-ray
    • Good - Good quality and easily able to see required anatomical landmarks for measurement
    • Adequate - Poor quality but just able to see required anatomical landmarks for measurement
    • Poor - Unable to see required anatomical landmarks for measurement

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Sheffield Children's NHS Foundation Trust

Other

Collaborators

  • University of Sheffield

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 22, 2024
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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