NCT05678894

Brief Summary

The main objective is to show that the upper acetabular anteversions calculated in standing, sitting, sitting hip in maximum flexion and supine positions are lower in patients with symptomatic DWI compared to healthy volunteers.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Sep 2023Sep 2027

First Submitted

Initial submission to the registry

December 22, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

September 28, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

3 years

First QC Date

December 22, 2022

Last Update Submit

November 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Anteversions comparison

    Comparison of anteversions of the superior plane of the acetabulum obtained from 3D CT reconstruction of the pelvis positioned standing, seated, seated hip in maximum flexion, and supine after matching by low-dose EOS X-ray images, between patients with symptomatic DWI and healthy volunteers.

    Day 0

Secondary Outcomes (8)

  • Functional limitation

    Month 6

  • Functional limitation

    Month 24

  • Subject quality of life

    Month 6

  • Subject quality of life

    Month 24

  • Return to previous activities

    Month 6

  • +3 more secondary outcomes

Study Arms (2)

femoro-acetabular impingement

EXPERIMENTAL

symptomatic patients with femoro-acetabular impingement

Other: Scanner and EOS imaging

Healthy volunteers

OTHER

Healthy volunteers

Other: Scanner and EOS imaging

Interventions

Cross-sectional imaging and 3D reconstruction to measure and compare acetabular anteversion in 4 functional pelvic positions.

Healthy volunteersfemoro-acetabular impingement

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient at least 18 years of age but \< 50 years of age
  • Patient with a confirmed diagnosis of DWI for whom arthroscopic impingement surgery is proposed
  • Patient who has given and signed free and informed consent
  • A patient who is a member of a social security plan or a beneficiary of such a plan
  • Person at least 18 years of age but \< 50 years of age
  • Person with no existing DWI diagnosis
  • Person who has given and signed free and informed consent
  • Person affiliated with a social security plan or beneficiary of such a plan

You may not qualify if:

  • Patient who has already undergone surgery on the same hip
  • Patient with previous spine surgery
  • Patient already included in the study for the opposite hip
  • Pregnant or breastfeeding patient
  • Patient who did not give consent
  • Patient for whom it is impossible to give informed information
  • Mentally impaired or any other reason that may interfere with understanding
  • Patient under court protection, guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique de la Sauvegarde

Lyon, 69009, France

RECRUITING

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 10, 2023

Study Start

September 28, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2027

Last Updated

December 3, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations