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| Name | Class |
|---|---|
| University of Sheffield | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEXA Scan | Radiation | If the participant consents to take part in the trial, they will have an additional DEXA scan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheffield Children's NHS Foundation Trust | Sheffield | S10 2TH | United Kingdom |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D015502 | Absorptiometry, Photon |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Through study completion, an average of 6 months |
| D003720 |
| Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |