Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Correlation of functional and health status outcomes vs. RSA |
Analyses to examine the correlation of functional and health status outcomes vs. RSA observations may be explored |
2 years |
|
Primary |
Mean superior cup migration (subsidence) at 2 years |
RSA measured mean superior cup migration (subsidence: Y translation in mm) at 2 years for each surgical approach separately, as well as combined |
2 years |
|
Secondary |
RSA measured cup subsidence at 3 months |
RSA measured subsidence (in mm) of the Pinnacle Acetabular Shell |
3 months |
|
Secondary |
X-axis translation of acetabular shell at 3 months |
RSA measured X-axis translation of acetabular shell in mm |
3 months |
|
Secondary |
Z-axis translation of acetabular shell at 3 months |
RSA measured Z-axis translation of acetabular shell in mm |
3 months |
|
Secondary |
X-axis rotation of the acetabular shell at 3 months |
RSA measured X-axis rotation of the acetabular shell measured in degrees |
3 months |
|
Secondary |
Y-axis rotation of the acetabular shell at 3 months |
RSA measured Y-axis rotation of the acetabular shell measured in degrees |
3 months |
|
Secondary |
Z-axis rotation of the acetabular shell at 3 months |
RSA measured Z-axis rotation of the acetabular shell measured in degrees |
3 months |
|
Secondary |
Maximal total point motion of the acetabular shell at 3 months |
RSA measured maximal total point motion of the acetabular shell in mm |
3 months |
|
Secondary |
Harris Hip Score at 3 months |
Functional and health status as measured with the Harris Hip Score. This is a validated scoring system of the hip that has a result range of 0-100; the higher the score, the better the patient outcome. |
3 months |
|
Secondary |
HOOS Jr. Score at 3 months |
Functional and health status as measured with the HOOS Jr. score. This is a short version of the HOOS (hip disability and osteoarthritis outcome score) that has a result range of 0-100. A score of 0 indicates total hip disability and 100 indicates perfect hip health. |
3 months |
|
Secondary |
FJS-12 at 3 months |
Functional and health status as measured with the Forgotten Joint Score (FJS-12). This is a validated score that assesses patient outcomes. The result range is 0-100 where a higher score mean a more favorable result. |
3 months |
|
Secondary |
RSA measured cup subsidence at 6 months |
RSA measured subsidence (in mm) of the Pinnacle Acetabular Shell |
6 months |
|
Secondary |
X-axis translation of acetabular shell at 6 months |
RSA measured X-axis translation of acetabular shell in mm |
6 months |
|
Secondary |
Z-axis translation of acetabular shell at 6 months |
RSA measured Z-axis translation of acetabular shell in mm |
6 months |
|
Secondary |
X-axis rotation of the acetabular shell at 6 months |
RSA measured X-axis rotation of the acetabular shell measured in degrees |
6 months |
|
Secondary |
Y-axis rotation of the acetabular shell at 6 months |
RSA measured Y-axis rotation of the acetabular shell measured in degrees |
6 months |
|
Secondary |
Z-axis rotation of the acetabular shell at 6 months |
RSA measured Z-axis rotation of the acetabular shell measured in degrees |
6 months |
|
Secondary |
Maximal total point motion of the acetabular shell at 6 months |
RSA measured maximal total point motion of the acetabular shell in mm |
6 months |
|
Secondary |
Harris Hip Score at 6 months |
Functional and health status as measured with the Harris Hip Score. This is a validated scoring system of the hip that has a result range of 0-100; the higher the score, the better the patient outcome. |
6 months |
|
Secondary |
HOOS Jr. Score at 6 months |
Functional and health status as measured with the HOOS Jr. score. This is a short version of the HOOS (hip disability and osteoarthritis outcome score) that has a result range of 0-100. A score of 0 indicates total hip disability and 100 indicates perfect hip health. |
6 months |
|
Secondary |
FJS-12 at 6 months |
Functional and health status as measured with the Forgotten Joint Score (FJS-12). This is a validated score that assesses patient outcomes. The result range is 0-100 where a higher score mean a more favorable result. |
6 months |
|
Secondary |
RSA measured cup subsidence at 1 year |
RSA measured subsidence (in mm) of the Pinnacle Acetabular Shell |
1 year |
|
Secondary |
X-axis translation of acetabular shell at 1 year |
RSA measured X-axis translation of acetabular shell in mm |
1 year |
|
Secondary |
Z-axis translation of acetabular shell at 1 year |
RSA measured Z-axis translation of acetabular shell in mm |
1 year |
|
Secondary |
X-axis rotation of the acetabular shell at 1 year |
RSA measured X-axis rotation of the acetabular shell measured in degrees |
1 year |
|
Secondary |
Y-axis rotation of the acetabular shell at 1 year |
RSA measured Y-axis rotation of the acetabular shell measured in degrees |
1 year |
|
Secondary |
Z-axis rotation of the acetabular shell at 1 year |
RSA measured Z-axis rotation of the acetabular shell measured in degrees |
1 year |
|
Secondary |
Maximal total point motion of the acetabular shell at 1 year |
RSA measured maximal total point motion of the acetabular shell in mm |
1 year |
|
Secondary |
Harris Hip Score at 1 year |
Functional and health status as measured with the Harris Hip Score. This is a validated scoring system of the hip that has a result range of 0-100; the higher the score, the better the patient outcome. |
1 year |
|
Secondary |
HOOS Jr. Score at 1 year |
Functional and health status as measured with the HOOS Jr. score. This is a short version of the HOOS (hip disability and osteoarthritis outcome score) that has a result range of 0-100. A score of 0 indicates total hip disability and 100 indicates perfect hip health. |
1 year |
|
Secondary |
FJS-12 at 1 year |
Functional and health status as measured with the Forgotten Joint Score (FJS-12). This is a validated score that assesses patient outcomes. The result range is 0-100 where a higher score mean a more favorable result. |
1 year |
|
Secondary |
X-axis translation of acetabular shell at 2 years |
RSA measured X-axis translation of acetabular shell in mm |
2 years |
|
Secondary |
Z-axis translation of acetabular shell at 2 years |
RSA measured Z-axis translation of acetabular shell in mm |
2 years |
|
Secondary |
X-axis rotation of the acetabular shell at 2 years |
RSA measured X-axis rotation of the acetabular shell measured in degrees |
2 years |
|
Secondary |
Y-axis rotation of the acetabular shell at 2 years |
RSA measured Y-axis rotation of the acetabular shell measured in degrees |
2 years |
|
Secondary |
Z-axis rotation of the acetabular shell at 2 years |
RSA measured Z-axis rotation of the acetabular shell measured in degrees |
2 years |
|
Secondary |
Maximal total point motion of the acetabular shell at 2 years |
RSA measured maximal total point motion of the acetabular shell in mm |
2 years |
|
Secondary |
Harris Hip Score at 2 years |
Functional and health status as measured with the Harris Hip Score. This is a validated scoring system of the hip that has a result range of 0-100; the higher the score, the better the patient outcome. |
2 years |
|
Secondary |
HOOS Jr. Score at 2 years |
Functional and health status as measured with the HOOS Jr. score. This is a short version of the HOOS (hip disability and osteoarthritis outcome score) that has a result range of 0-100. A score of 0 indicates total hip disability and 100 indicates perfect hip health. |
2 years |
|
Secondary |
FJS-12 at 2 years |
Functional and health status as measured with the Forgotten Joint Score (FJS-12). This is a validated score that assesses patient outcomes. The result range is 0-100 where a higher score mean a more favorable result. |
2 years |
|
Secondary |
Linear head penetration at 1 year |
Amount of linear head penetration compared to baseline (6 weeks) measured in mm |
1 year |
|
Secondary |
Linear head penetration at 2 years |
Amount of linear head penetration compared to baseline (6 weeks) measured in mm |
2 years |
|