NCT05893823

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2023

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2025

Completed
17 days until next milestone

Results Posted

Study results publicly available

July 1, 2025

Completed
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

May 26, 2023

Results QC Date

June 16, 2025

Last Update Submit

June 16, 2025

Conditions

Keywords

Iliopsoas ImpingementOverhanging Cup

Outcome Measures

Primary Outcomes (5)

  • 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)

Study Arms (2)

Cases

Patients that have symptomatic psoas impingement in a protruding acetabular cup documented by a Pelvis CT scan

Diagnostic Test: Pelvis CT scan

Controls

Asymptomatic patients with a protruding acetabular cup documented by a Pelvis CT scan

Diagnostic Test: Pelvis CT scan

Interventions

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.

CasesControls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Primary total hip arthroplasty
  • Execution of a postoperative Ct scan for pain, noises or planning of the contralateral THA
  • years minimum follow-up for the control group, tenotomy of the iliopsoas muscle in the cases group
  • Complete clinical and radiological data

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, 40141, Italy

Location

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Results Point of Contact

Title
Francesco Castagnini
Organization
IRCCS Istituto Ortopedico Rizzoli

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2023

First Posted

June 8, 2023

Study Start

June 6, 2022

Primary Completion

June 6, 2023

Study Completion

June 14, 2025

Last Updated

July 1, 2025

Results First Posted

July 1, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations