Coxofemoral Pathologies Clinical Trial
— HIPOfficial title:
Transcultural and Psychometric Validation of SUSHI and HOOS-12 Scores in Patients With Coxofemoral Pathologies
| NCT number | NCT04470232 |
| Other study ID # | 20_RIPH3-03 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | September 11, 2020 |
| Est. completion date | March 2023 |
The management of coxofemoral pathologies is constantly increasing. In addition to degenerative hip pathology, the orthopedic surgeon is now confronted with pathologies such as femoro-acetabular conflict, pathologies of the gluteus medius and pathologies of the labrum whose early management limits arthritis degeneration. These pathologies are mainly encountered in young subjects (<60 years). Self-questionnaires play an important role in understanding patients' point of view on the impact of their coxofemoral pathologies and also allow an assessment of their condition after treatment. For the evaluation of coxofemoral pathologies in the young subject (<60 years) the Super Simple Hip score (SUSHI-score) was developed and validated. In the elderly subject with hip osteoarthritis, the HOOS score has the advantage of specifically measuring pain, symptoms, function and quality of life, but is made up of 40 items and is often considered rather heavy to submit. However, it has recently been simplified and the HOOS-12 (HOOS score with 12 items) has been developed and validated. These two scores are useful in current clinical practice but they are only validated in English.
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | March 2023 |
| Est. primary completion date | September 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Adult patient (age greater than or equal to 18 years old), - Patient with coxofemoral pathology, - Patient having been informed of the research, - Patient agreeing to participate in the study. Exclusion Criteria: - Minor patient, - Pregnant woman, - Patient out of state to agree to participate in the study, - Patient unable to answer a self-assessment questionnaire, - Patient under justice, guardianship or curatorship, - Patient who refused to participate in the study. |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Lariboisière - AP-HP | Paris | |
| France | Centre Hospitalier Privé Saint-Grégoire | Saint-Grégoire | |
| Martinique | CHU of Martinique | Fort-de-France |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Center of Martinique | Lariboisière Hospital, Saint-Gregoire Private Hospital Center |
France, Martinique,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Transcultural validation of the SUSHI-score and HOOS-12 score questionnaire | It will be a question of obtaining a version translated into French. The translated version tested on a small group of patients (15) will be submitted to the author of the original version of the tool, along with a report highlighting and explaining all the modifications and difficulties noted by a group of experts. | 1 month | |
| Primary | Psychometric validation of the SUSHI-score and HOOS-12 score questionnaire | Questionnaires will be passed by 120 subjects. Following parameters will be measured: feasibility and acceptability, validity, reliability, and sensitivity to change. | 12 months |