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| Name | Class |
|---|---|
| DMS Apelem | INDUSTRY |
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Dual-energy X-ray Absorptiometry is frequently used to measure bone mineral density. A new medical device, Box 3D DXA, creates a 3D image using a statistics reconstruction model developed on the femur. This new imaging technique does not require additional irradiation and ought to improve bone measures as well as incorporating densitometric parameters into the diagnosis. This study will test the reconstruction of the 3D image from lombar spine measurements and compare accuracy against measurements made using CT scan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2nd lumbar spine acquisition in same position | Active Comparator | spine and hip STRATOS DR + 2nd lumbar spine acquisition in same position (with template) |
|
| 2nd lumbar spine acquisition | Active Comparator | spine and hip STRATOS DR + 2nd lumbar spine acquisition (no template) |
|
| 2nd hip acquisition in same position | Active Comparator | spine and hip STRATOS DR + 2nd hip acquisition in same position (with template) |
|
| 2nd hip acquisition | Active Comparator | spine and hip STRATOS DR + 2nd hip acquisition (without template) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DXA + CT | Other | Two dual-energy X-ray scans + CT scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concordance in lombar spine measurements between box 3D-DXA (index test) and CT scan (reference test) | Lin's concordance coefficient | Day 0 |
| Concordance in lombar spine measurements between box 3D-DXA (index test) and CT scan (reference test) | Bland Altman plot | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Reproducibility of the 3D-DXA Spine algorithm for lombar spine measurements | 2 acquisitions under the same conditions. Using root-mean-square coefficient of variation to calculate the Least Significant Change | Day 0 |
| Robustness of 3D-DXA Spine measurement for lombar spine measurements |
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Inclusion Criteria:
Exclusion Criteria:
60 anatomical females and 60 anatomical males
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nimes | Nîmes | 30029 | France |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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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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2 acquisitions under the same conditions. Using interquartile range as a measure of dispersion of the variable |
| Day 0 |
| Concordance in femur measurements between box 3D-DXA (index test) and CT scan (reference test) | Lin's concordance coefficient | Day 0 |
| Concordance in femur measurements between box 3D-DXA (index test) and CT scan (reference test) | Bland Altman plot | Day 0 |
| Reproducibility of the 3D-DXA Femur algorithm for femur measurements | 2 acquisitions under the same conditions. Using root-mean-square coefficient of variation to calculate the Least Significant Change | Day 0 |
| Robustness of 3D-DXA Femur measurement for femur measurements | 2 acquisitions under the same conditions. Using interquartile range as a measure of dispersion of the variable | Day 0 |
| D003720 |
| Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |