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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A02482-47 | Other Identifier | Agence nationale de sécurité du médicament et des produits de santé |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulnar Longitudinal Deficiency Observational Cohort | This arm represents a non-interventional observational cohort of children and adolescents with ulnar longitudinal deficiency. No intervention is assigned as part of the study. Clinical, radiological, and rehabilitation data are collected retrospectively from existing medical records and prospectively through parent-reported outcome questionnaires (PROMIS and ABILHAND-Kids-CP), without any modification of standard clinical care. |
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| Measure | Description | Time Frame |
|---|---|---|
| Upper limb function and health-related quality of life (PROMIS Upper Extremity and ABILHAND-Kids) | Upper limb function and health-related quality of life will be assessed using validated parent-reported outcome measures:
| From baseline to study completion (up to 10 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Upper limb functional ability score | 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. | From baseline to study completion (up to 10 months) |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of children and adolescents aged 3 to 18 years diagnosed with ulnar longitudinal deficiency, either unilateral or bilateral.
Participants are followed at a tertiary referral center for upper limb malformations and have available medical records allowing retrospective data extraction. Parent-reported outcome measures are collected prospectively as part of the study without modifying standard clinical care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Auriane AS SLAMA | Contact | 0143967556 | auriane.slama@ght94n.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Paris Est Val-de-Marne - Centre de Référence des Malformations des Membres | Saint-Maurice | 94410 | France |
Individual participant data will not be shared due to the small sample size, the pediatric population involved, and the need to ensure participant confidentiality in accordance with applicable data protection regulations.
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| Pediatric upper limb function |
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. |
| From baseline to study completion (up to 10 months) |
| Pediatric health-related quality of life | 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. | From baseline to study completion (up to 10 months) |