- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07624474
Validation, in a Pediatric Population, of a French Translation of the MEPS/MEPI Score (MEPS-Fr)
June 10, 2026 updated by: Centre Hospitalier Universitaire, Amiens
The MEPI (Modified Elbow Performance Index) or MEPS (Modified Elbow Performance Score) is a multidimensional assessment scale for elbow pain and function.
This score is widely used in scientific literature, particularly for post-traumatic and post-operative evaluation, including in many French-language studies.
However, no French translation of this score has undergone quality criteria verification and validation in a pediatric population.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
170
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Céline KLEIN, Pr
- Phone Number: 36 186 33+3 22 08 80 00
- Email: klein.celine@chu-amiens.fr
Study Locations
-
-
-
Amiens, France, 80054
- Recruiting
- CHU Amiens
-
Contact:
- Céline Klein, MD
- Phone Number: (33)322087571
- Email: klein.celine@chu-amiens.fr
-
-
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
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Pre-test volunteer group:
- Patients aged 4 to 17 years followed in the department without an elbow injury
- Follow-up schedule compatible with the study protocol
- No objection from a parent or legal guardian, with the child's consent if age permits
- Test volunteer group:
- Patients aged 4 to 17 years followed in the department with a diagnosis of an elbow injury
- Follow-up schedule compatible with the study protocol
- No objection from a parent or legal guardian, with the child's consent
Exclusion Criteria:
- Pre-test volunteer group:
- Language barrier, lack of understanding of French
- Refusal to participate
- Confounding factor impairing function
- Opposition of parent or legal guardian and/or refusal of child if age permits
- Test volunteer group:
- Language barrier, lack of understanding of French
- Refusal to participate
- Confounding factor impairing function
- Opposition of parent or legal guardian and/or refusal of child if age permits
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
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: pre-test
patients without elbow injury
|
The MEPS-Fr version will be tested on 120 patients treated either orthopedically or surgically for an elbow injury
|
|
Experimental: validation test
patients treated either orthopedically or surgically for an elbow injury.
|
The MEPS-Fr version will be tested on 120 patients treated either orthopedically or surgically for an elbow injury
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MEPS-FR score
Time Frame: day 0
|
Mayo Elbow Performance Score (MEPS)
|
day 0
|
|
MEPS-FR score
Time Frame: 6 weeks
|
Mayo Elbow Performance Score (MEPS)
|
6 weeks
|
|
MEPS-FR score
Time Frame: 12 weeks
|
Mayo Elbow Performance Score (MEPS)
|
12 weeks
|
|
PREE Score
Time Frame: day 0
|
The Patient-Rated Elbow Evaluation is PREE
|
day 0
|
|
PREE Score
Time Frame: 6 weeks
|
The Patient-Rated Elbow Evaluation is PREE
|
6 weeks
|
|
PREE Score
Time Frame: 12 weeks
|
The Patient-Rated Elbow Evaluation is PREE
|
12 weeks
|
|
quick DASH Score
Time Frame: day 0
|
DASH is Disabilities of the Arm, Shoulder and Hand
|
day 0
|
|
quick DASH Score
Time Frame: 6 weeks
|
DASH is Disabilities of the Arm, Shoulder and Hand
|
6 weeks
|
|
quick DASH Score
Time Frame: 12 weeks
|
DASH is Disabilities of the Arm, Shoulder and Hand
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
April 13, 2026
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
July 1, 2028
Study Registration Dates
First Submitted
May 28, 2026
First Submitted That Met QC Criteria
May 28, 2026
First Posted (Actual)
June 3, 2026
Study Record Updates
Last Update Posted (Actual)
June 12, 2026
Last Update Submitted That Met QC Criteria
June 10, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PI2025_843_0157
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.