NCT06571604

Brief Summary

This study looks at how fat buildup in hip muscles relates to hip osteoarthritis and less favorable recovery after hip replacement surgery. While it is known that weak gluteal muscles might cause problems, it is not yet proven if this specifically leads to hip dislocation after surgery. The goal of this study is to compare fat buildup in gluteal muscles between patients who had a hip dislocation soon after surgery and those who did not.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

1.2 years

First QC Date

August 23, 2024

Last Update Submit

August 23, 2024

Conditions

Keywords

Total Hip ArthroplastyMuscle Fatty DegenerationCTGluteal Muscles

Outcome Measures

Primary Outcomes (1)

  • Mean Attenuation Ratio

    The mean attenuation ratio (MAR), representing muscle fat degeneration, corresponds to the mean grayscale pixels in the selected area, expressed in Hounsfield Units (HU). Subsequently, the segmentation process was applied, selectively retaining pixels within the range of -30 HU to 150 HU. This range corresponds to muscle fibers and intramuscular fat, effectively excluding extra-fascial fat and bone pixels.

    The CT scan of the pelvis used to plan the operation is performed between one and two months before the surgery.

Secondary Outcomes (2)

  • Cross-Sectional Area

    The CT scan of the pelvis used to plan the operation is performed between one and two months before the surgery.

  • Intramuscular Fatty Fraction

    The CT scan of the pelvis used to plan the operation is performed between one and two months before the surgery.

Study Arms (2)

Dislocation group

Patients who underwent primary total hip arthroplasty with preoperative CT-scan and encountered an episode of dislocation.

Diagnostic Test: Dislocation

Control group

Patients underwent primary total hip arthroplasty with preoperative CT-scan, who did not experience any episodes of dislocation within two years post-surgery, adhering to the previously outlined exclusion criteria (group control).

Diagnostic Test: No dislocation

Interventions

DislocationDIAGNOSTIC_TEST

One episode of total hip dislocation diagnozied on Xray within 2 years of surgery

Dislocation group
No dislocationDIAGNOSTIC_TEST

No experience of dislocation within two years post-surgery

Control group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients following THA at Nimes university hospital

You may qualify if:

  • primary THA with preoperative CT-scan

You may not qualify if:

  • malposition of acetabular implants outside the Lewinneck safe zone,
  • neurological or cognitive disorders,
  • associated spinal pathologies (within the context of a hip-spine syndrome),
  • chronic alcoholism,
  • aseptic osteonecrosis,
  • revision surgeries,
  • late dislocations attributed to polyethylene wear,
  • replacement following post-traumatic coxarthrosis due to acetabulum injuries.
  • diameters of the prosthetic heads ≠ 32mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nîmes

Nîmes, Gard, 30900, France

Location

MeSH Terms

Conditions

Joint Dislocations

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesWounds and Injuries

Study Design

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

Study Record Dates

First Submitted

August 23, 2024

First Posted

August 26, 2024

Study Start

January 1, 2020

Primary Completion

March 1, 2021

Study Completion

May 1, 2023

Last Updated

August 26, 2024

Record last verified: 2024-08

Locations