Preoperative Gluteal Muscle Atrophy: A Silent Predictor of THA Dislocation.

August 23, 2024 updated by: Centre Hospitalier Universitaire de Nīmes
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Gard
      • Nîmes, Gard, France, 30900
        • CHU Nîmes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients following THA at Nimes university hospital

Description

Inclusion Criteria:

  • primary THA with preoperative CT-scan

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Dislocation group
Patients who underwent primary total hip arthroplasty with preoperative CT-scan and encountered an episode of dislocation.
Diagnostic test: Dislocation
One episode of total hip dislocation diagnozied on Xray within 2 years of surgery
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
No experience of dislocation within two years post-surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Attenuation Ratio
Time Frame: The CT scan of the pelvis used to plan the operation is performed between one and two months before the surgery.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cross-Sectional Area
Time Frame: The CT scan of the pelvis used to plan the operation is performed between one and two months before the surgery.
The cross-sectional area (CSA), measured in square centimeters (cm²) defines the average muscle surface 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
Time Frame: The CT scan of the pelvis used to plan the operation is performed between one and two months before the surgery.
Finally, the intramuscular fatty fraction (IFF) or percentage of intramuscular fat was calculated using the IB Delta Suite plug-in with thresholds of -30/0/150. Pixels below -30 HU and above 150 HU were designated as extra-muscular, while pixels ranging between 0 HU and 150 HU represented muscle fibers. Pixels falling between -30 HU and 0 HU denoted intramuscular fat, constituting the IFF.
The CT scan of the pelvis used to plan the operation is performed between one and two months before the surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • THAdislocation glutealatrophy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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