Hip Impingement SyndromeNCT05893823
Retrospective Study on Radiological Factors Predictive of Psoas Impingement
An observational study of Hip Impingement Syndrome and Prosthetic Complication, run by Istituto Ortopedico Rizzoli at 2 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Impingement Syndrome, Prosthetic Complication
- What is being tested?
- Pelvis CT scan
- How many people
- 52 participants
- Where
- 2 sitesItaly
- Study dates
- 6 Jun 2022to 14 Jun 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Istituto Ortopedico Rizzoli
Bologna, Emilia-Romagna, 40141
IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136
About this study
Official title: 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.
- Conditions
- Hip Impingement Syndrome, Prosthetic Complication
- Being tested
- Pelvis CT scan
- Keywords
- Iliopsoas Impingement, Overhanging Cup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvis CT scanDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients that have symptomatic psoas impingement in a protruding acetabular cup documented by a Pelvis CT scan Receives: Diagnostic Test: Pelvis CT scan | |
| Controls | Asymptomatic patients with a protruding acetabular cup documented by a Pelvis CT scan Receives: Diagnostic Test: Pelvis CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acetabular Cup Antiversion
The angle between the tangent to the cup opening and the tangent to the posterior ischial spines in the axial plane
Measured: at baseline (day 0)
Acetabular Cup Inclination
The angle between the tangent to the cup opening and the interteardrop line in the frontal plane
Measured: at baseline (day 0)
Femoral Offset
The distance between the center of rotation and the femoral axis in the frontal plane
Measured: at baseline (day 0)
Acetabular Offset
The distance between the center of rotation and the Kohler line in the frontal plane
Measured: 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
Measured: at baseline (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start6 Jun 2022
- Primary completion6 Jun 2023
- Study completion14 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hip Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893823
- Sponsor's protocol ID
- PSOAS IMP
- Status last verified
- Jun 2025
- First submitted
- 26 May 2023
- Last updated
- 1 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study on Radiological Factors Predictive of Symptomatic Psoas Impingement Development in Protruding Cups in Primary Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT05893823
- Acronym / sponsor ID
- PSOAS IMP
- Conditions
- Hip Impingement Syndrome, Prosthetic Complication
- Keywords
- Iliopsoas Impingement, Overhanging Cup
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 14 Jun 2025 (actual)
- First posted
- 8 Jun 2023 (actual)
- Results
- Posted 1 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Diagnostic Test: Pelvis CT scanPatients that have symptomatic psoas impingement in a protruding acetabular cup documented by a Pelvis CT scan |
| Controls | – | Diagnostic Test: Pelvis CT scanAsymptomatic patients with a protruding acetabular cup documented by a Pelvis CT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvis CT scanPost-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. | Diagnostic test | Cases, Controls |
Primary outcome
Acetabular Cup Antiversion
Time frame: at baseline (day 0)
The angle between the tangent to the cup opening and the tangent to the posterior ischial spines in the axial plane
Acetabular Cup Inclination
Time frame: at baseline (day 0)
The angle between the tangent to the cup opening and the interteardrop line in the frontal plane
Femoral Offset
Time frame: at baseline (day 0)
The distance between the center of rotation and the femoral axis in the frontal plane
Acetabular Offset
Time frame: at baseline (day 0)
The distance between the center of rotation and the Kohler line in the frontal plane
Eccentric Reaming
Time frame: at baseline (day 0)
The distance between the native hip center of rotation and the acetabular cup center of rotation in the axial plane
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Impingement Syndrome and Prosthetic Complication, run by Istituto Ortopedico Rizzoli at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acetabular Cup Antiversion (time frame: at baseline (day 0)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.