- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04470232
Transcultural and Psychometric Validation of SUSHI and HOOS-12 Scores in Patients With Coxofemoral Pathologies (HIP)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mathieu SEVERYNS, MD
- Phone Number: +596 05 96 55 22 21
- Email: mathieu.severyns@chu-martinique.fr
Study Locations
-
-
-
Paris, France, 75010
- Recruiting
- Hôpital Lariboisière - AP-HP
-
Contact:
- Guillaume ODRI, MD
- Phone Number: +33 01 49 95 91 51
- Email: guillaume.odri@ap-hp.fr
-
Principal Investigator:
- Guillaume ODRI, MD
-
Saint-Grégoire, France, 35760
- Recruiting
- Centre Hospitalier Privé Saint-Grégoire
-
Contact:
- Charles KAJETANEK, MD
- Phone Number: +33 02 23 25 30 85
- Email: charles.kajetanek@gmail.com
-
Principal Investigator:
- Charles Kajetanek, MD
-
-
-
-
-
Fort-de-France, Martinique, 97261
- Recruiting
- CHU of Martinique
-
Contact:
- Mathieu SEVERYNS, MD
- Phone Number: +596 05 96 55 22 21
- Email: mathieu.severyns@chu-martinique.fr
-
Principal Investigator:
- Mathieu SEVERYNS, MD
-
Sub-Investigator:
- Lucas MATTESI, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with coxofemoral pathologies
For the transcultural validation, a french version of the 2 self-assessment questionnaires, SUSHI-score and the HOOs-12 score will be produced. For the psychometric validation, 120 patients with coxofemoral pathologies will pass the two questionnaires. The HAGOS (Hip and Groin Score) questionnaire will be also passed by the subject, for the convergent validity. |
120 patients with coxofemoral pathologies will pass the SUSHI-score and the HOOS-12 score questionnaires. The HAGOS (Hip and Groin Score) questionnaire will be also passed by the subject, for the convergent validity. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Transcultural validation of the SUSHI-score and HOOS-12 score questionnaire
Time Frame: 1 month
|
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
|
Psychometric validation of the SUSHI-score and HOOS-12 score questionnaire
Time Frame: 12 months
|
Questionnaires will be passed by 120 subjects.
Following parameters will be measured: feasibility and acceptability, validity, reliability, and sensitivity to change.
|
12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20_RIPH3-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Coxofemoral Pathologies
-
University Hospital, Strasbourg, FranceCompletedIncurable PathologiesFrance
-
AO Clinical Investigation and Publishing DocumentationSynthes Inc.CompletedHindfoot Arthrodesis | Hindfoot PathologiesUnited States, Germany, France, Sweden
-
W.L.Gore & AssociatesActive, not recruitingMultiple PathologiesAustralia, Italy, United States, Brazil
-
University Hospital, ToulouseCompletedSinonasal PathologiesFrance
-
Ain Shams Maternity HospitalUnknownGynecological PathologiesEgypt
-
University Hospital Inselspital, BerneRecruitingLung Pathologies of Unclear EtiologySwitzerland
-
University Hospital, Strasbourg, FranceRecruitingSleep Disorders | Neurological Pathologies | Psychiatric Pathologies | Ophthalmological PathologiesFrance
-
OptovueCompletedNormal Eyes and Eyes With Ocular PathologiesUnited States
-
Centre Hospitalier Universitaire de NiceCompleted
-
Laboratoires TheaIris Pharma; Axial Biotech, IncCompletedMeibomian Gland Dysfunction | Ocular Surface Disease | Palpebral PathologiesGermany, Spain
Clinical Trials on Self-assessment questionnaires
-
University Hospital Center of MartiniqueCompletedDiabetes Mellitus | Diabetes | Diabetes Complications | Foot Ulcer, DiabeticFrance
-
University Hospital, Strasbourg, FranceCompletedChronic Rhinosinusitis | Post-viral Anosmia | Post-traumatic Anosmia | Idiopathic Anosmia | Age-related Loss of SmellFrance
-
University Medical Centre MariborFaculty of Medicine, University of MariborCompletedSelf-Injurious Behavior | Self Injurious Behavior Without Suicidal Intent
-
University of California, San FranciscoAmerican Society of Clinical Oncology; Conquer Cancer FoundationRecruitingGynecologic Cancer | Malignant Female Reproductive System Neoplasm | Gynecologic NeoplasmUnited States
-
Jonsson Comprehensive Cancer CenterAmerican Cancer Society, Inc.TerminatedBreast Cancer | FatigueUnited States
-
Centre Francois BaclesseARCAGY/ GINECO GROUPActive, not recruitingGerm Cell Tumor | Sex Cord Stromal Tumor | Malignant Non-epithelial Ovarian TumorsFrance
-
Centre Henri BecquerelCompleted
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Hospices Civils de LyonNot yet recruitingQuality of Life | Medical ResidentsFrance
-
M.D. Anderson Cancer CenterCompletedAdvanced Cancer | Malignant Neoplasms of Independent (Primary) Multiple SitesUnited States