Coxofemoral PathologiesHIPNCT04470232
Transcultural and Psychometric Validation of SUSHI and HOOS-12 Scores in Patients With Coxofemoral Pathologies
An observational study of Coxofemoral Pathologies, run by University Hospital Center of Martinique at 3 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coxofemoral Pathologies
- What is being tested?
- Self-assessment questionnaires
- How many people
- 120 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 11 Sep 2020to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a coxofemoral pathology.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites, 2 recruiting
- Recruiting
Hôpital Lariboisière - AP-HP
Paris, 75010
Guillaume ODRI, MD, 01 49 95 91 51 ext. +33, guillaume.odri@ap-hp.fr
Guillaume ODRI, MD
- Recruiting
Centre Hospitalier Privé Saint-Grégoire
Saint-Grégoire, 35760
Charles KAJETANEK, MD, 02 23 25 30 85 ext. +33, charles.kajetanek@gmail.com
Charles KAJETANEK, MD
Martinique1 site, 1 recruiting
- Recruiting
CHU of Martinique
Fort-de-France, 97261
Mathieu SEVERYNS, MD, 05 96 55 22 21 ext. +596, mathieu.severyns@chu-martinique.fr
Mathieu SEVERYNS, MD
About this study
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).
Read more
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.
- Conditions
- Coxofemoral Pathologies
- Being tested
- Self-assessment questionnaires
- Keywords
- Coxofemoral pathologies, Self assessment questionnaire, Super Simple Hip score (SUSHI-score), Hip disability and Osteoarthritis Outcome Score (HOOS score), Transcultural validation, Psychometric validation, Hip and Groin score (HAGOS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-assessment questionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Self-assessment questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start11 Sep 2020
- Primary completionSep 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coxofemoral PathologiesStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital Lariboisière, Saint-Gregoire Private Hospital Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470232
- Sponsor's protocol ID
- 20_RIPH3-03
- Acronym
- HIP
- Status last verified
- Dec 2021
- First submitted
- 9 Jul 2020
- Last updated
- 13 Jun 2022
- 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 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcultural and Psychometric Validation of SUSHI and HOOS-12 Scores in Patients With Coxofemoral Pathologies
- ClinicalTrials.gov ID
- NCT04470232
- Acronym / sponsor ID
- HIP / 20_RIPH3-03
- Conditions
- Coxofemoral Pathologies
- Keywords
- Coxofemoral pathologies, Self assessment questionnaire, Super Simple Hip score (SUSHI-score), Hip disability and Osteoarthritis Outcome Score (HOOS score), Transcultural validation, Psychometric validation, Hip and Groin score (HAGOS)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Collaborators
- Hopital Lariboisière, Saint-Gregoire Private Hospital Center
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 14 Jul 2020 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with coxofemoral pathologies | – | Other: Self-assessment questionnairesFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a coxofemoral pathology.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
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 |
|---|---|---|
| Self-assessment questionnaires120 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. | Other | Patients with coxofemoral pathologies |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- 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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coxofemoral Pathologies, run by University Hospital Center of Martinique at 3 sites in 2 countries.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Martinique. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathieu SEVERYNS, MD (05 96 55 22 21 ext. +596, mathieu.severyns@chu-martinique.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcultural validation of the SUSHI-score and HOOS-12 score questionnaire (time frame: 1 month). The study lists 2 primary outcomes in all. 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 13 Jun 2022.