Transcultural and Psychometric Validation of SUSHI and HOOS-12 Scores in Patients With Coxofemoral Pathologies

NCT04470232 | Unknown

• 1 other identifier: 20_RIPH3-03
• Study Type: observational
• Target: 120
• Locations: 2 countries
• Sites: 3

Brief 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 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.

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)

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

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.

Other: Self-assessment questionnaires

Interventions

Self-assessment questionnaires OTHER

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.

Patients with coxofemoral pathologies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a coxofemoral pathology.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Center of Martinique: lead
• Lariboisière Hospital: collaborator
• Saint-Gregoire Private Hospital Center: collaborator

Study Sites (3)

Hôpital Lariboisière - AP-HP

Paris, 75010, France

RECRUITING

Centre Hospitalier Privé Saint-Grégoire

Saint-Grégoire, 35760, France

RECRUITING

CHU of Martinique

Fort-de-France, 97261, Martinique

RECRUITING

Central Study Contacts

Mathieu SEVERYNS, MD

CONTACT

05 96 55 22 21; mathieu.severyns@chu-martinique.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 14, 2020
• Study Start: September 11, 2020
• Primary Completion: September 1, 2022
• Study Completion: March 1, 2023
• Last Updated: June 13, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1); FR (2)