Psoas TendinitisERATONCT05029648
Evaluation of Predictive Factors for Psoas Tendinitis After First-line Total Hip Arthroplasty
An observational study of Psoas Tendinitis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Evaluation of predictive factors for psoas tendinitis after first-line total hip arthroplasty. A single-centre retrospective study of medical data from the medical records of patients undergoing total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoas Tendinitis
- What is being tested?
- Cohort
- How many people
- 1,199 participants
- Where
- 1 siteFrance
- Study dates
- 11 Aug 2011to 19 Jun 2024
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients who have had a total hip replacement for at least six months.
Who may be able to join
- Patient aged 18 years or older, having been informed of the research
- Patient who has had a total hip replacement implanted for at least six months as a first-line treatment
- Patient who has been regularly monitored since the operation and for whom all clinical and radiological data are available during follow-up visits
Who cannot join
- Patient undergoing revision surgery
- Patient who has indicated his opposition to the use of his medical data
- Patient under legal protection, guardianship or curators
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of predictive factors for psoas tendinitis after first-line total hip arthroplasty.
A single-centre retrospective study of medical data from the medical records of patients undergoing total hip arthroplasty.
Read the detailed description
From the medical records of a series of patients operated on for total hip arthroplasty:
Main objective: To assess individual and surgical factors associated with the development of psoas tendinitis.
Secondary objectives:
- To describe the frequency of occurrence of psoas tendinitis
- To describe the outcome of patients who underwent tenotomy.
- Conditions
- Psoas Tendinitis
- Being tested
- Cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CohortOther
Cohort
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Simple cohort Receives: Other: Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoas tendinitis development
Pain remission after tenotomy.
Measured: 6 months
Secondary outcomes (2)
Psoas tendinitis occurrence frequency
Frequency of occurrence of psoas tendinitis
Measured: 6 months
To describe the outcome of patients who have undergone tenotomy
To describe the outcome of patients who have undergone tenotomy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start11 Aug 2011
- Primary completion19 Jun 2024
- Study completion19 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoas TendinitisStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,199 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas BONIN, MD, Principal investigator, Clinique de la Sauvegarde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029648
- Sponsor's protocol ID
- COS-RGDS-2019-12-054
- Acronym
- ERATO
- Status last verified
- Jul 2024
- First submitted
- 16 Aug 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Predictive Factors for Psoas Tendinitis After First-line Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT05029648
- Acronym / sponsor ID
- ERATO / COS-RGDS-2019-12-054
- Conditions
- Psoas Tendinitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,199 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 11 Aug 2011 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 19 Jun 2024 (actual)
- First posted
- 31 Aug 2021 (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.
Evaluation of predictive factors for psoas tendinitis after first-line total hip arthroplasty.
A single-centre retrospective study of medical data from the medical records of patients undergoing total hip arthroplasty.
Detailed description
From the medical records of a series of patients operated on for total hip arthroplasty:
Main objective: To assess individual and surgical factors associated with the development of psoas tendinitis.
Secondary objectives:
- To describe the frequency of occurrence of psoas tendinitis
- To describe the outcome of patients who underwent tenotomy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Other: CohortSimple cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who have had a total hip replacement for at least six months.
Key inclusion criteria (3 listed)
- Patient aged 18 years or older, having been informed of the research
- Patient who has had a total hip replacement implanted for at least six months as a first-line treatment
- Patient who has been regularly monitored since the operation and for whom all clinical and radiological data are available during follow-up visits
Key exclusion criteria (3 listed)
- Patient undergoing revision surgery
- Patient who has indicated his opposition to the use of his medical data
- Patient under legal protection, guardianship or curators
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 |
|---|---|---|
| CohortCohort | Other | Cohort |
Primary outcome
Psoas tendinitis development
Time frame: 6 months
Pain remission after tenotomy.
2 secondary outcomes
Psoas tendinitis occurrence frequency
Time frame: 6 months
To describe the outcome of patients who have undergone tenotomy
Time frame: 6 months
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 3 Jul 2024.
- Individual participant dataSharing planned: No
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.
Nicolas BONIN, MD principal investigator
Clinique de la Sauvegarde
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 Psoas Tendinitis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 3 inclusion and 3 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 3 Jul 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?
Psoas tendinitis development (time frame: 6 months). 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 3 Jul 2024.