Hôpitaux Paris Est Val-de-Marne - Centre de Référence des Malformations des Membres
Saint-Maurice, 94410, France
Location contact
Adrien AL Leluc, MD
CONTACT
Adrien AL Leluc, MD
PRINCIPAL_INVESTIGATOR
Not Yet Recruiting
NCT Number: NCT07404514
Longitudinal Ulnar Deficit (ULNEER)
The management of patients with longitudinal ulnar deficiency is a clinical challenge due to the rarity of this condition and the wide variety of its manifestations. In particular, there is no consensus in the literature on the indications for surgery.
The aim of this research is to improve understanding and management of this malformation by analyzing existing data from patient medical follow-up.
No new clinical evaluations or occupational therapy assessments will be performed specifically for this study.
The analysis will be based on previous medical and paramedical data (consultation reports, imaging, occupational therapy assessments, etc.) in order to better describe the functional evolution of patients and identify the decision-making criteria that guide surgical management.
Parents will also receive standardized questionnaires (PROMIS and ABILHAND-Kids-CP) to gather their perceptions of their child's quality of life and independence.
The results will be used to propose recommendations for a more consistent and multidisciplinary assessment of longitudinal ulnar deficit in the future.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Age range
3 year–18 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients with unilateral or bilateral ulnar hand deformity, whether operated on or not
- Follow-up at CEREFAM and/or Trousseau Hospital
- Complete medical records containing previous assessments
Exclusion criteria
- Non-French-speaking patient
- No preoperative or postoperative assessment
Treatment and study plan
Primary outcomes
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Upper limb function and health-related quality of life (PROMIS Upper Extremity and ABILHAND-Kids)
Time frame: From baseline to study completion (up to 10 months)
Upper limb function and health-related quality of life will be assessed using validated parent-reported outcome measures:
- The Pediatric Outcomes Measurement Information System (PROMIS) Upper Extremity Pediatric questionnaire. PROMIS scores are standardized T-scores with a mean of 50 and a standard deviation of 10 in the reference population. Scores typically range from approximately 0 to 100, with higher scores indicating better upper limb function.
- The ABILHAND-Kids questionnaire (Assessment of Manual Ability for Children). ABILHAND-Kids scores are converted into a scaled measure ranging from 0 to 100, with higher scores indicating better manual ability.
Secondary outcomes
-
Upper limb functional ability score
Time frame: From baseline to study completion (up to 10 months)
Upper limb functional ability will be assessed using the ABILHAND-Kids questionnaire (Assessment of Manual Ability for Children). Scores are converted into a scaled measure ranging from 0 to 100, with higher scores indicating better manual ability.
-
Pediatric upper limb function
Time frame: From baseline to study completion (up to 10 months)
Upper limb function will be assessed using the Pediatric Outcomes Measurement Information System (PROMIS) Upper Extremity Pediatric questionnaire. PROMIS scores are standardized T-scores with a mean of 50 and a standard deviation of 10 in the reference population. Scores typically range from approximately 0 to 100, with higher scores indicating better upper limb function.
-
Pediatric health-related quality of life
Time frame: From baseline to study completion (up to 10 months)
Health-related quality of life will be assessed using the Pediatric Outcomes Measurement Information System (PROMIS) Pediatric Global Health questionnaire. PROMIS scores are standardized T-scores with a mean of 50 and a standard deviation of 10 in the reference population. Scores typically range from approximately 0 to 100, with higher scores indicating better health-related quality of life.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Hopitaux de Saint-Maurice
Other
Registry information
Official study title
Prospective and Retrospective Observational Study on Longitudinal Ulnar Deficit: Analysis of Existing Medical Data and Parental Questionnaires
Acronym: ULNEER
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Feb 11, 2026
- Registry last updated
- Feb 13, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.