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The purpose of this study is to identify radiological factors on TC of the hip that could lead to prediction of development of symptomatic psoas impingement in patients with protruding acetabular cup after primary total hip arthroplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | Patients that have symptomatic psoas impingement in a protruding acetabular cup documented by a Pelvis CT scan |
| |
| Controls | Asymptomatic patients with a protruding acetabular cup documented by a Pelvis CT scan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvis CT scan | Diagnostic Test | Post-THA hip pelvis CT scan execution for pain, noise or THA planning for the controlateral hip, with identification of acetabular cup protrusion. Comparation of cases and controls to identify radiological factors that could potentially lead to symptomatic psoas impingement prediction. |
| Measure | Description | Time Frame |
|---|---|---|
| Acetabular Cup Antiversion | The angle between the tangent to the cup opening and the tangent to the posterior ischial spines in the axial plane | at baseline (day 0) |
| Acetabular Cup Inclination | The angle between the tangent to the cup opening and the interteardrop line in the frontal plane | at baseline (day 0) |
| Femoral Offset | The distance between the center of rotation and the femoral axis in the frontal plane | at baseline (day 0) |
| Acetabular Offset | The distance between the center of rotation and the Kohler line in the frontal plane | at baseline (day 0) |
| Eccentric Reaming | The distance between the native hip center of rotation and the acetabular cup center of rotation in the axial plane | at baseline (day 0) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who had undergone a total hip arthroplasty with symptoms of iliopsoas impingement and radiological evidence of a protruding acetabular cup, detected on a Ct scan
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Bologna | Emilia-Romagna | 40141 | Italy | ||
| IRCCS Istituto Ortopedico Rizzoli |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cases | Patients that have symptomatic psoas impingement in a protruding acetabular cup documented by a Pelvis CT scan |
| FG001 | Controls | Asymptomatic patients with a protruding acetabular cup documented by a Pelvis CT scan |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cases | Patients that have symptomatic psoas impingement in a protruding acetabular cup documented by a Pelvis CT scan |
| BG001 | Controls | Asymptomatic patients with a protruding acetabular cup documented by a Pelvis CT scan |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acetabular Cup Antiversion | The angle between the tangent to the cup opening and the tangent to the posterior ischial spines in the axial plane | Posted | Mean | Standard Deviation | degree | at baseline (day 0) |
|
at baseline (day 0)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cases | Patients that have symptomatic psoas impingement in a protruding acetabular cup documented by a Pelvis CT scan |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Francesco Castagnini | IRCCS Istituto Ortopedico Rizzoli | 0516366418 | +39 | francescocastagnini@hotmail.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2025 | Jun 15, 2025 | Prot_SAP_000.pdf |
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|
| Bologna |
| 40136 |
| Italy |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Cup protrusion | Cup protrusion on sagittal plane and on frontal plane measured in millimeters: from the cup edge to anterior wall, at the center of the head | Mean | Standard Deviation | millimeters |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Acetabular Cup Inclination | The angle between the tangent to the cup opening and the interteardrop line in the frontal plane | Posted | Mean | Standard Deviation | degree | at baseline (day 0) |
|
|
|
| Primary | Femoral Offset | The distance between the center of rotation and the femoral axis in the frontal plane | Posted | Mean | Standard Deviation | millimeters | at baseline (day 0) |
|
|
|
| Primary | Acetabular Offset | The distance between the center of rotation and the Kohler line in the frontal plane | Posted | Mean | Standard Deviation | millimeters | at baseline (day 0) |
|
|
|
| Primary | Eccentric Reaming | The distance between the native hip center of rotation and the acetabular cup center of rotation in the axial plane | Posted | Mean | Standard Deviation | millimeters | at baseline (day 0) |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Controls | Asymptomatic patients with a protruding acetabular cup documented by a Pelvis CT scan | 0 | 17 | 0 | 17 | 0 | 17 |
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