Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Presence of at least one fracture in the dorsal spine evaluated with a classical, standard-dose scan (Gold standard) |
YES/NO |
Day 0 |
|
| Primary |
Presence of at least one fracture in the lumbar spine evaluated with a classical, standard-dose scan (Gold standard) |
YES/NO |
Day 0 |
|
| Primary |
Presence of at least one fracture of the pelvis and proximal femurs evaluated with a classical, standard-dose scan (Gold standard) |
YES/NO |
Day 0 |
|
| Primary |
Presence of at least one fracture of the hands / wrists evaluated with a classical, standard-dose scan (Gold standard) |
YES/NO |
Day 0 |
|
| Primary |
Presence of at least one fracture of the feet /ankles evaluated with a classical, standard-dose scan (Gold standard) |
YES/NO |
Day 0 |
|
| Primary |
Presence of at least one fracture in the dorsal spine evaluated with a ULD scan |
YES/NO |
Day 0 |
|
| Primary |
Presence of at least one fracture in the lumbar spine evaluated with a ULD scan |
YES/NO |
Day 0 |
|
| Primary |
Presence of at least one fracture in the pelvis and proximal femurs evaluated with a ULD scan |
YES/NO |
Day 0 |
|
| Primary |
Presence of at least one fracture of the hands / wrists evaluated with a ULD scan |
YES/NO |
Day 0 |
|
| Primary |
Presence of at least one fracture of the feet /ankles evaluated with a ULD scan |
YES/NO |
Day 0 |
|
| Primary |
Presence of at least one fracture of the dorsal spine evaluated with a standard X-ray |
YES/NO |
Day 0 |
|
| Primary |
Presence of at least one fracture of the lumbar spine evaluated with a standard X-ray |
YES/NO |
Day 0 |
|
| Primary |
Presence of at least one fracture of the pelvis and proximal femurs evaluated with a standard X-ray |
YES/NO |
Day 0 |
|
| Primary |
Presence of at least one fracture of the hands / wrists evaluated with a standard X-ray |
YES/NO |
Day 0 |
|
| Primary |
Presence of at least one fracture of the feet /ankles evaluated with a standard X-ray |
YES/NO |
Day 0 |
|
| Secondary |
Presence of an abnormality of the bone structure at the anatomic site(s) concerned evaluated with a classical Gold Standard scan |
YES/NO |
Day 0 |
|
| Secondary |
Presence of an abnormality of the soft tissues at the anatomic site(s) concerned evaluated with a classical Gold Standard scan |
YES/NO |
Day 0 |
|
| Secondary |
Presence of an abnormality of the joints at the anatomic site(s) concerned evaluated with a classical Gold Standard scan |
YES/NO |
Day 0 |
|
| Secondary |
Presence of an abnormality of the invertebral discs at the anatomic site(s) concerned evaluated with a classical Gold Standard scan |
YES/NO |
Day 0 |
|
| Secondary |
Presence of an abnormality of the bone structure at the anatomic site(s) concerned evaluated with a ULD scan |
YES/NO |
Day 0 |
|
| Secondary |
Presence of an abnormality of the soft tissues at the anatomic site(s) concerned evaluated with a ULD scan |
YES/NO |
Day 0 |
|
| Secondary |
Presence of an abnormality of the joints at the anatomic site(s) concerned evaluated with a ULD scan |
YES/NO |
Day 0 |
|
| Secondary |
Presence of an abnormality of the invertebral discs at the anatomic site(s) concerned evaluated with a ULD scan |
YES/NO |
Day 0 |
|
| Secondary |
Presence of an abnormality of the bone structure at the anatomic site(s) concerned evaluated with a standard X-ray |
YES/NO |
Day 0 |
|
| Secondary |
Presence of an abnormality of the soft tissues at the anatomic site(s) concerned evaluated with a standard X-ray |
YES/NO |
Day 0 |
|
| Secondary |
Presence of an abnormality of the joints at the anatomic site(s) concerned evaluated with a standard X-ray |
YES/NO |
Day 0 |
|
| Secondary |
Presence of an abnormality of the intervertebral discs at the anatomic concerned site(s) evaluated with a standard X-ray |
YES/NO |
Day 0 |
|
| Secondary |
Image quality of the ULD scanner and standard X-ray |
By means of a 4-point Likert scale, both the senior and junior radiologists can give their subjective impression of the overall image quality of each of the two examination methods under study (ULD scan vs. standard X-ray) by saying how much they agree or disagree that the overall quality of the image is good enough to detect a fracture. On the Lickert scale, 1- Uninterpretable, 2- Interpretable in spite of a slight technical problem (centering, movement, constant), 3-Completely interpretable in spite of a slight technical problem. 4- No technical problem. |
Day 0 |
|
| Secondary |
Diagnostic quality of the ULD scanner and standard X-ray |
Using a 5-point Lickert scale (in which 1= Inacceptable, 2 = Sub-optimal, 3 = Acceptable, 4 = Above average, 5- Excellent) both the senior and junior radiologists will give their subjective impression of the overall diagnostic quality of each of the two examination methods under study (ULD scan vs. standard X-ray). |
Day 0 |
|
| Secondary |
Confidence level of the ULD scanner and standard X-ray |
Using a 5-point Lickert scale (1- Very poor, 2- Poor, 3- Fair, 4- Good, 5- Excellent) both the senior and junior radiologists will give their subjective impression of their overall level of confidence in the diagnosis made for each of the two examination methods under study (ULD scan vs. standard X-ray). |
Day 0 |
|
| Secondary |
Effective dose for each exam with the ULD scanner |
No. of millisieverts (mSv) |
Day 0 |
|
| Secondary |
Effective dose for each exam with the standard X-ray |
No. of millisieverts (mSv) |
Day 0 |
|
| Secondary |
Interpretation time for each exam with the ULD scanner |
Measured in minutes |
Day 0 |
|
| Secondary |
Interpretation time for each exam with the standard X-ray |
Measured in minutes |
Day 0 |
|
