DislocationNCT06571604
Preoperative Gluteal Muscle Atrophy: A Silent Predictor of THA Dislocation.
An observational study of Dislocation and Total Hip Arthroplasty, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dislocation, Total Hip Arthroplasty, Muscle Degeneration
- What is being tested?
- Dislocation and No dislocation
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 1 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients following THA at Nimes university hospital
Who may be able to join
- primary THA with preoperative CT-scan
Who cannot join
- 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,
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- late dislocations attributed to polyethylene wear,
- replacement following post-traumatic coxarthrosis due to acetabulum injuries.
- diameters of the prosthetic heads ≠ 32mm
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Dislocation, Total Hip Arthroplasty, Muscle Degeneration
- Being tested
- Dislocation, No dislocation
- Keywords
- Total Hip Arthroplasty, Muscle Fatty Degeneration, CT, Gluteal Muscles
- Medical subject headings
- Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DislocationDiagnostic test
One episode of total hip dislocation diagnozied on Xray within 2 years of surgery
No dislocationDiagnostic test
No experience of dislocation within two years post-surgery
| Study group | Role | What they receive |
|---|---|---|
| Dislocation group | Patients who underwent primary total hip arthroplasty with preoperative CT-scan and encountered an episode of dislocation. Receives: 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). Receives: Diagnostic Test: No dislocation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 cross-sectional area (CSA), measured in square centimeters (cm²) defines the average muscle surface area.
Measured: The CT scan of the pelvis used to plan the operation is performed between one and two months before the surgery.
Intramuscular Fatty Fraction
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.
Measured: The CT scan of the pelvis used to plan the operation is performed between one and two months before the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Jan 2020
- Primary completion1 Mar 2021
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DislocationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571604
- Sponsor's protocol ID
- THAdislocation glutealatrophy
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Gluteal Muscle Atrophy: A Silent Predictor of THA Dislocation.
- ClinicalTrials.gov ID
- NCT06571604
- Acronym / sponsor ID
- THAdislocation glutealatrophy
- Conditions
- Dislocation, Total Hip Arthroplasty, Muscle Degeneration
- Keywords
- Total Hip Arthroplasty, Muscle Fatty Degeneration, CT, Gluteal Muscles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dislocation group | – | Diagnostic Test: DislocationPatients who underwent primary total hip arthroplasty with preoperative CT-scan and encountered an episode of dislocation. |
| Control group | – | Diagnostic Test: No dislocationPatients 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients following THA at Nimes university hospital
Key inclusion criteria (1 listed)
- primary THA with preoperative CT-scan
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DislocationOne episode of total hip dislocation diagnozied on Xray within 2 years of surgery | Diagnostic test | Dislocation group |
| No dislocationNo experience of dislocation within two years post-surgery | Diagnostic test | Control group |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dislocation and Total Hip Arthroplasty, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.