Evaluation of Predictive Factors for Psoas Tendinitis After First-line Total Hip Arthroplasty (ERATO)

July 1, 2024 updated by: GCS Ramsay Santé pour l'Enseignement et la Recherche

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1199

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
      • Lyon, France, 69009
        • Clinique de la Sauvegarde

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients who have had a total hip replacement for at least six months.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient undergoing revision surgery
  • Patient who has indicated his opposition to the use of his medical data
  • Patient under legal protection, guardianship or curators

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
Intervention / Treatment
Cohort
Simple cohort
Other: Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psoas tendinitis development
Time Frame: 6 months
Pain remission after tenotomy.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psoas tendinitis occurrence frequency
Time Frame: 6 months
Frequency of occurrence of psoas tendinitis
6 months
To describe the outcome of patients who have undergone tenotomy
Time Frame: 6 months
To describe the outcome of patients who have undergone tenotomy
6 months

Collaborators and Investigators

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

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Investigators

  • Principal Investigator: Nicolas BONIN, MD, Clinique de la Sauvegarde

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)

August 11, 2011

Primary Completion (Actual)

June 19, 2024

Study Completion (Actual)

June 19, 2024

Study Registration Dates

First Submitted

August 16, 2021

First Submitted That Met QC Criteria

August 25, 2021

First Posted (Actual)

August 31, 2021

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

July 1, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COS-RGDS-2019-12-054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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