Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512038
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-08
Brief Title:
The Use of DXA in Scoliosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Study of the Use of Dual-Energy X-ray Absorptiometry DXA in Scoliosis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Childrens Hospital Scoliosis PPI group will feedback on key aspects during the study and help define future studies suggested by this study
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 Childrens Hospital Scoliosis PPI group will feedback on key aspects during the study and help define future studies suggested by this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None