MEPIMEPS-FrNCT07624474
Validation, in a Pediatric Population, of a French Translation of the MEPS/MEPI Score
A study testing MEPS-Fr version in people with MEPI and MEPS, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- What is being tested?
- MEPS-Fr version
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- 13 Apr 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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:
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80054
Céline Klein, MD, (33)322087571, klein.celine@chu-amiens.fr
About this study
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.
- Conditions
- MEPI, MEPS, PREE, DASH Elbow
- Being tested
- MEPS-Fr version
- Keywords
- MEPI, MEPS, PREE, DASH elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEPS-Fr versionDevice
The MEPS-Fr version will be tested on 120 patients treated either orthopedically or surgically for an elbow injury
| Study group | Role | What they receive |
|---|---|---|
| pre-test | Active comparator | patients without elbow injury Receives: Device: MEPS-Fr version |
| validation test | Experimental | patients treated either orthopedically or surgically for an elbow injury. Receives: Device: MEPS-Fr version |
What is being measured
The primary outcome is the main question the study is designed to answer.
MEPS-FR score
Mayo Elbow Performance Score (MEPS)
Measured: day 0
MEPS-FR score
Mayo Elbow Performance Score (MEPS)
Measured: 6 weeks
MEPS-FR score
Mayo Elbow Performance Score (MEPS)
Measured: 12 weeks
PREE Score
The Patient-Rated Elbow Evaluation is PREE
Measured: day 0
PREE Score
The Patient-Rated Elbow Evaluation is PREE
Measured: 6 weeks
PREE Score
The Patient-Rated Elbow Evaluation is PREE
Measured: 12 weeks
quick DASH Score
DASH is Disabilities of the Arm, Shoulder and Hand
Measured: day 0
quick DASH Score
DASH is Disabilities of the Arm, Shoulder and Hand
Measured: 6 weeks
quick DASH Score
DASH is Disabilities of the Arm, Shoulder and Hand
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start13 Apr 2026
- Primary completionApr 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MEPIStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624474
- Sponsor's protocol ID
- PI2025_843_0157
- Acronym
- MEPS-Fr
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 12 Jun 2026
- 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation, in a Pediatric Population, of a French Translation of the MEPS/MEPI Score
- ClinicalTrials.gov ID
- NCT07624474
- Acronym / sponsor ID
- MEPS-Fr / PI2025_843_0157
- Conditions
- MEPI, MEPS, PREE, DASH Elbow
- Keywords
- MEPI, MEPS, PREE, DASH elbow
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 3 Jun 2026 (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 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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-test | Active comparator | Device: MEPS-Fr versionpatients without elbow injury |
| validation test | Experimental | Device: MEPS-Fr versionpatients treated either orthopedically or surgically for an elbow injury. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| MEPS-Fr versionThe MEPS-Fr version will be tested on 120 patients treated either orthopedically or surgically for an elbow injury | Device | pre-test, validation test |
Primary outcome
MEPS-FR score
Time frame: day 0
Mayo Elbow Performance Score (MEPS)
MEPS-FR score
Time frame: 6 weeks
Mayo Elbow Performance Score (MEPS)
MEPS-FR score
Time frame: 12 weeks
Mayo Elbow Performance Score (MEPS)
PREE Score
Time frame: day 0
The Patient-Rated Elbow Evaluation is PREE
PREE Score
Time frame: 6 weeks
The Patient-Rated Elbow Evaluation is PREE
PREE Score
Time frame: 12 weeks
The Patient-Rated Elbow Evaluation is PREE
quick DASH Score
Time frame: day 0
DASH is Disabilities of the Arm, Shoulder and Hand
quick DASH Score
Time frame: 6 weeks
DASH is Disabilities of the Arm, Shoulder and Hand
quick DASH Score
Time frame: 12 weeks
DASH is Disabilities of the Arm, Shoulder and Hand
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for MEPI
Not yet recruiting
A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers
Venous Leg Ulcer (VLU), Compression Bandages
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEPS-Fr version in people with MEPI and MEPS, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 8 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Céline KLEIN, Pr (33+3 22 08 80 00 ext. 36 186, klein.celine@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MEPS-FR score (time frame: day 0). The study lists 9 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 12 Jun 2026.