- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05893823
Retrospective Study on Radiological Factors Predictive of Psoas Impingement
June 16, 2025 updated by: Istituto Ortopedico Rizzoli
Retrospective Study on Radiological Factors Predictive of Symptomatic Psoas Impingement Development in Protruding Cups in Primary Hip Arthroplasty
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
52
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bologna, Italy, 40136
- IRCCS Istituto Ortopedico Rizzoli
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Emilia Romagna
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Bologna, Emilia Romagna, Italy, 40141
- Istituto Ortopedico Rizzoli
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
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
Description
Inclusion Criteria:
- Primary total hip arthroplasty
- Execution of a postoperative Ct scan for pain, noises or planning of the contralateral THA
- 5 years minimum follow-up for the control group, tenotomy of the iliopsoas muscle in the cases group
- Complete clinical and radiological data
Exclusion Criteria:
- Patient's refusal to participate
- Non adequate Ct scans or made for periprosthetic fractures, component mobilization, periprosthetic infection or wearing of the prosthesis
- Incomplete clinical and radiological data
- Inadequate follow-up or regression of the iliopsoas impingement symptoms with non-operative treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cases
Patients that have symptomatic psoas impingement in a protruding acetabular cup documented by a Pelvis CT scan
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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.
|
|
Controls
Asymptomatic patients with a protruding acetabular cup documented by a Pelvis CT scan
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eccentric Reaming
Time Frame: at baseline (day 0)
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The distance between the native hip center of rotation and the acetabular cup center of rotation in the axial plane
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at baseline (day 0)
|
|
Acetabular Cup Antiversion
Time Frame: at baseline (day 0)
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The angle between the tangent to the cup opening and the tangent to the posterior ischial spines in the axial plane
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at baseline (day 0)
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|
Acetabular Cup Inclination
Time Frame: at baseline (day 0)
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The angle between the tangent to the cup opening and the interteardrop line in the frontal plane
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at baseline (day 0)
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|
Femoral Offset
Time Frame: at baseline (day 0)
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The distance between the center of rotation and the femoral axis in the frontal plane
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at baseline (day 0)
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Acetabular Offset
Time Frame: at baseline (day 0)
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The distance between the center of rotation and the Kohler line in the frontal plane
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at baseline (day 0)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2022
Primary Completion (Actual)
June 6, 2023
Study Completion (Actual)
June 14, 2025
Study Registration Dates
First Submitted
May 26, 2023
First Submitted That Met QC Criteria
June 7, 2023
First Posted (Actual)
June 8, 2023
Study Record Updates
Last Update Posted (Estimated)
July 1, 2025
Last Update Submitted That Met QC Criteria
June 16, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PSOAS IMP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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