Trial Outcomes & Findings for Retrospective Study on Radiological Factors Predictive of Psoas Impingement (NCT NCT05893823)

NCT ID: NCT05893823

Last Updated: 2025-07-01

Results Overview

The angle between the tangent to the cup opening and the tangent to the posterior ischial spines in the axial plane

Recruitment status

COMPLETED

Target enrollment

52 participants

Primary outcome timeframe

at baseline (day 0)

Results posted on

2025-07-01

Participant Flow

Participant milestones

Participant milestones
Measure
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
Overall Study
STARTED
35
17
Overall Study
COMPLETED
35
17
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cases
n=35 Participants
Patients that have symptomatic psoas impingement in a protruding acetabular cup documented by a Pelvis CT scan
Controls
n=17 Participants
Asymptomatic patients with a protruding acetabular cup documented by a Pelvis CT scan
Total
n=52 Participants
Total of all reporting groups
Age, Continuous
53.5 years
STANDARD_DEVIATION 11.8 • n=35 Participants
54.1 years
STANDARD_DEVIATION 15.3 • n=17 Participants
53.7 years
STANDARD_DEVIATION 12.9 • n=52 Participants
Sex: Female, Male
Female
20 Participants
n=35 Participants
9 Participants
n=17 Participants
29 Participants
n=52 Participants
Sex: Female, Male
Male
15 Participants
n=35 Participants
8 Participants
n=17 Participants
23 Participants
n=52 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Cup protrusion
Cup protrusion on sagital plane
12.8 millimeters
STANDARD_DEVIATION 5.6 • n=35 Participants
14.9 millimeters
STANDARD_DEVIATION 5.4 • n=17 Participants
13.5 millimeters
STANDARD_DEVIATION 5.6 • n=52 Participants
Cup protrusion
Cup protrusion on frontal plane
5.9 millimeters
STANDARD_DEVIATION 4.8 • n=35 Participants
7.6 millimeters
STANDARD_DEVIATION 3.4 • n=17 Participants
6.4 millimeters
STANDARD_DEVIATION 4.5 • n=52 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Cases
n=35 Participants
Patients that have symptomatic psoas impingement in a protruding acetabular cup documented by a Pelvis CT scan
Controls
n=17 Participants
Asymptomatic patients with a protruding acetabular cup documented by a Pelvis CT scan
Acetabular Cup Antiversion
19.8 degree
Standard Deviation 9.5
11.5 degree
Standard Deviation 9.4

PRIMARY outcome

Timeframe: at baseline (day 0)

The angle between the tangent to the cup opening and the interteardrop line in the frontal plane

Outcome measures

Outcome measures
Measure
Cases
n=35 Participants
Patients that have symptomatic psoas impingement in a protruding acetabular cup documented by a Pelvis CT scan
Controls
n=17 Participants
Asymptomatic patients with a protruding acetabular cup documented by a Pelvis CT scan
Acetabular Cup Inclination
41.8 degree
Standard Deviation 6.9
43.5 degree
Standard Deviation 5.8

PRIMARY outcome

Timeframe: at baseline (day 0)

The distance between the center of rotation and the femoral axis in the frontal plane

Outcome measures

Outcome measures
Measure
Cases
n=35 Participants
Patients that have symptomatic psoas impingement in a protruding acetabular cup documented by a Pelvis CT scan
Controls
n=17 Participants
Asymptomatic patients with a protruding acetabular cup documented by a Pelvis CT scan
Femoral Offset
40.2 millimeters
Standard Deviation 5.8
38.4 millimeters
Standard Deviation 7.7

PRIMARY outcome

Timeframe: at baseline (day 0)

The distance between the center of rotation and the Kohler line in the frontal plane

Outcome measures

Outcome measures
Measure
Cases
n=35 Participants
Patients that have symptomatic psoas impingement in a protruding acetabular cup documented by a Pelvis CT scan
Controls
n=17 Participants
Asymptomatic patients with a protruding acetabular cup documented by a Pelvis CT scan
Acetabular Offset
32.0 millimeters
Standard Deviation 4.5
33.8 millimeters
Standard Deviation 5.6

PRIMARY outcome

Timeframe: at baseline (day 0)

The distance between the native hip center of rotation and the acetabular cup center of rotation in the axial plane

Outcome measures

Outcome measures
Measure
Cases
n=35 Participants
Patients that have symptomatic psoas impingement in a protruding acetabular cup documented by a Pelvis CT scan
Controls
n=17 Participants
Asymptomatic patients with a protruding acetabular cup documented by a Pelvis CT scan
Eccentric Reaming
1.8 millimeters
Standard Deviation 4.0
0.8 millimeters
Standard Deviation 3.7

Adverse Events

Cases

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Controls

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Francesco Castagnini

IRCCS Istituto Ortopedico Rizzoli

Phone: 0516366418

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place